Environmental, Health and Safety (EHS) Management and Audit

An environmental, health and safety (EHS) management and audit program is now a prerequisite for organizations in various kinds of business. Allied to the emergence of and developing along with the concepts of worker safety and corporate social responsibility; the environmental, health and safety audit is today a major component of an organization. Organizations that need visibility and are desirous of earning a good name should make the environmental, health and safety management and audit a part of their culture.
The practice of companies auditing their environmental, health and safety (EHS) began in the 1970’s, almost contemporaneously with the enactment of OSHA. Around that time, the environmental issue was gaining ground in the corporate circles of the West with the governments and other agencies pitching in with their efforts to create greater awareness of the impact of business activities on the environment. As a result, the thinking that the top management of an organization needs to be viewing this issue more seriously started to develop and got ingrained over the years.
Cannot be glossed over
As a result of various legislations on the issue of environmental safety; the role of the Board of Governors became central in ensuring this aspect of the business. Environmental health and safety was no longer something that needed to be administered superficially, but in formal and designated ways, more specifically in the form of an audit. In order to incentivize corporate entities to implement environmental health and safety (EHS) management and audit; the trend started moving towards making these activities carry value addition to the organization.
Environmental health and safety management and audit is now a more formalized activity that needs to be carried out in a proper, set and well-defined manner. The processes that go into the EHS management and audit are clearly laid out in the form of standards such as the ISO 14001 standard, which is essentially an Environmental Management System (EMS) audit. To strengthen and enrich the audit activity and round it better; a few related and parallel standards such as the relevant parts of the 9000 family of standards, which deals with quality management, and 18000 series audits can be carried out with ease to supplement the environmental, health and safety audit.
Role of environmental health and safety (EHS) management and audit
Environmental health and safety (EHS) management and audit have now evolved into being a practice that is coupled with and fused into many business-related activities. The practice now is to make an environmental health and safety management and audit an inseparable part of the Quality Management System. Environmental health and safety (EHS) management and audit audits are now a sure means to ensure that the organization has a reputation for corporate social responsibility by implementing this audit.

Aspects of an environmental health and safety management and auditThe aim of environmental health and safety management and audit is to instill the EHS right from the top management down to the line level employee. A properly carried out EHS management and audit system should ideally take these factors into consideration:

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Developing an effective HR compliance program

Organizations need to devote substantial time and effort into developing an effective HR compliance program. Development of an effective HR compliance program is a strong safeguard against unsavory and avoidable legal issues that could result from a shoddy HR compliance program or improper implementation.
Developing an effective HR compliance program is a must for organizations that could be in any business. A basic doubt in the minds of many people could be this: What has HR got to do with compliance? Isn’t compliance for only those in charge of implementing regulatory requirements? Yes, that is true. This is also what answers the question of why developing an effective HR compliance program is necessary: It is a regulatory requirement.
There are many regulations pertaining to HR. These regulations have come into existence because of the importance of proper hiring policies. Since HR is tasked with recruitment and everything else following this; HR compliance becomes necessary to ensure that the organization does not face legal hurdles vis-a-vis its hiring, working and firing policies. This is a primary reason for which developing an effective HR compliance program is a must.
Compliance is needed with various lawsOver the past few decades, successive US governments have enacted laws that have had a very major bearing on employment. Compliance with the various laws relating to employment, such as the Equal Employment Opportunities Act, Age Discrimination in Employment Act (ADEA) and Americans with Disabilities Act (ADA) is mandatory for organizations that come under their purview. Further, there are laws such as The Fair Labor Standards Act (FLSA), which was enacted to ensure that the employee does not get exploited by getting underpaid for the work she does.
Similarly, the OSHA standards are meant to ensure that the workplace is free of hazards. Depending on the kind of workplace, many OSHA provisions have to be complied with. In short, there are a host of employment laws that organizations have to comply with.
Developing an effective HR compliance program has to take all these laws into consideration and has to spell out the way in which it will ensure that the organization complies with the laws.

HR compliance is not a fixed or limited action planThe starting point to developing and implementing an effective HR compliance program is the realization that an HR compliance program is a journey, not a destination. This is why: it consists of a set of processes that relate to the various HR laws. There should be process for implementing recruitment laws. Due diligence must go into the recruiting methods to ensure that no wrong step was taken in the recruitment process. Then, there should be processes for the implementation of the next set of laws, those pertaining to employment conditions. When developing an effective HR compliance program, anti-discrimination laws, laws on sexual harassment, laws on dealing with violent employees or those who have addiction problems, laws on workplace safety and many others need be taken into consideration and carefully complied with.
Finally, there should be those dealing with legally tenable terminations.
Prerequisites for implementing an effective HR compliance programGiven the importance of developing an effective HR compliance program, the following are some of the conditions that will help to make it effective:

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How to choose a supply chain management solution

Any business that opts for a supply chain management solution has to have clarity on how to choose a supply chain management solution. This is because the supply chain management solution is expected to carry out a number of very important functions. Choosing the wrong or inappropriate one can backfire on the business and derail and impede, rather than ease its work.
Businesses have to take a few important factors into consideration when they have to choose a supply chain management solution. For the supply chain management solution to perform its function of facilitating the supply chain for the business, it needs to perform its functions smoothly without causing hiccups to the business. This is where the decision-making ability of the business owner comes into picture.
So, what factors need to be taken into consideration when a business has to choose a supply chain management solution? Try considering these:
1. Choose by industryThis is obviously a no brainer, but it is an important first consideration nevertheless in choosing a supply chain management solution. Many supply chain management solution providers sell the idea that these are one-size-fits-all solutions that work across a number of industries since the core functions are essentially the same.
This may be true to an extent, but while a number of functionalities are common across a few industries; it is important to get down to the one that is built for your business. A supply chain management solution that works best for retail, for example, may not be as effective for an automobile store. Getting down to the details and dissecting the functionality that the supply chain management solution performs for your particular industry is an important first step in choosing a supply chain management solution.

2. Define your needThis is the next important consideration when choosing a supply chain management solution. A number of supply chain management solutions are available in the market. Choose the one that suits your need the best. In order to do this, the business has to define its need to the fullest extent. It could take a few factors such as this into consideration:

3. Understand the integration function of the supply chain management solutionIntegration is, well, the very soul of a supply chain management solution. The business should have clarity on what functions need to be integrated into the supply chain management solution. The reason for which the integration function is built into a supply chain management solution is to facilitate synchronization of the whole chain. This makes it one of the core factors that determined how to choose a supply chain management solution.
4. Insist on the visibility featureVisibility is a great means for the business to have control over its sales, inventory, logistics, and a host of other functions. The supply chain management solution has to offer visibility on all these functions.

5. Customer relationship management (CRM)A supply chain management solution is incomplete if it does not come equipped with a strong CRM feature. The CRM is the determinant in helping to establish a good relationship with the customer. The CRM feature should enable the business to completely understand the nature of the orders and their status, plus, more importantly, help in customer query responses and other important customer-related features.

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The Challenges before the Supply Chain Management and Logistics Industry

A look at the challenges before the supply chain management and logistics industry is instructive. Huge figures sit rather incongruously with the reality of the industry, which is that while from a universal point of view, the industry has been growing at a steady rate and is set to continue the upward trend; it has its own set of challenges and inequalities, depending on the market one is analyzing. The challenges before the supply chain management and logistics industry need to be looked at, if one were to analyze the supply chain management and logistics industry.
Let us start with a look at the size of the supply chain management and logistics industry.

Impressive overall figuresThe supply chain management and logistics industry employs over six million workers of various cadres in the US alone, again a fair indication of its enormous size. The good news is that by 2018, the industry is expected to need nearly a million and a half jobs. What factors have pushed this industry into such growth figures?
From almost a decade, the supply chain management and logistics industry has been seeing new and rapid changes and developments. These developments have mostly been in high-specialty areas such as marketing, data analytics, management and human resources, are involved. The reason for which the industry is in need of such high specialization jobs is that technology has made such forays into the segment that models on which most supply chain-dependent businesses were built are no longer viable.
What are the challenges before the supply chain management and logistics industry?The challenges before the supply chain management and logistics industry are dispersed based on the market one is looking at. The major challenge for the mature markets such as the US and the other markets in the west is in finding new recruits despite its being an industry that is in need of workers. The main challenges before the supply chain management and logistics industry in advanced countries are:

Challenges before the supply chain management and logistics industry in developing economiesOn the other hand, the problems of developing markets such India, where the retail industry is growing at a rapid pace, entertaining hopes of fueling the growth prospects of the supply chain and logistics industry, are of a different nature. In developing countries, despite the recent high rate of growth in this industry; the problems concern lack of good infrastructure, lack of governmental regulation for an industry that largely is seen as belonging to the unorganized sector, and challenges to warehousing, all of which are directly related to the supply chain and logistics industry. A country like India has a long way to go before it can build the kind of infrastructure of the kind seen in the developed countries. Although it has a huge network of railroads and roads; the quality is pathetically low, affecting the efficiency of the supply chain. Delivery gets affected in an environment of poor infrastructure and low implementation of technology, although India is relatively stronger in the latter area. Logistics and warehousing need to improve in a large measure if the demand for growth in this sector has to be matched by the requisite infrastructure.
Infrastructure is the very backbone of this industry, and this is one of the biggest areas of weaknesses in India. This places major handicaps and hurdles right at the very heart of the industry that is poised for huge growth. A number of steps need to be taken if the challenges before the supply chain management and logistics industry have to be overcome.

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Trends that will shape Supply Chain and Logistics in 2017

Trends that will shape Supply Chain and Logistics in 2017 is an interesting topic to think about. Though most of the trends are a takeoff from the previous years, unless something really disrupting happens out of the blue at some point of time in the year; the signals are strong that the trends that emerged in the previous few years are set to solidify and get reinforced.
What are the trends that will shape supply chain and logistics in 2017?

For a sector that is dependent heavily on infrastructure for its working; there has been little of path breaking significance in terms of what has been added to the existing infrastructure in any country of significance in the world, at least not to the extent that it can impact the industry in a significant way. The Chinese hobbyhorse, the One Belt One Road (OBOR) initiative, is not slated for completion in this year. The completion of this grand project could spell a major change for the shape supply chain and logistics, but nothing of such drastic significance is set to take place in 2017.
In the other “happening” countries – for the supply chain and logistics industry that is – 2017 is not likely to see a signal shift. But the developments that have been happening over the past few years are likely to gather pace. Technology is one area in which the change is to be expected. While again, technology itself may not really be new till this point of time in this year; a few trends have been emerging, promising to make some impact on the shape supply chain and logistics industry in 2017.
Big Data as a driver of changeBig Data is the word on everyone’s lips. How can one expect an industry that is so completely data driven as logistics and supply chain to be insulated from its influence?

Transition to m-commerceA notable development that is expected in the supply chain and logistics in 2017 is the evolution of ecommerce into m-commerce. This again, is nothing new or defining for 2017, but the year is likely to see a continuation of the trend set earlier.

People all over the world are finding it much easier to shop with the help of their mobile devices, and are adapting to this medium, albeit at different levels and speed. The explosion in the number of smartphones being purchased globally has added impetus to m-commerce. Try-ons as a new trendA new feature of online shopping is the try-on option that consumers are now being given. Online shoppers are given the option of choosing 4-5 varieties of their chosen product. All these pieces are delivered with the order, and the consumer can try out each of them and select the one that she thinks suits her best. The idea is to replicate the actual shopping to the extent possible.
This trend has its challenges, for sure, because the cost of making it work could be unimaginably high. As with any new trend, it is going to be some time before the economies of scale of such huge logistical operations start kicking in. Yet, this is a very tangible factor that is sure to count among the supply chain and logistics trends of 2017.

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Global Supply Chain Regulatory Compliance

Global supply chain regulatory compliance has become more important than ever before because of the confluence of a number of factors. As globalization becomes inevitable and inescapable, the global supply chain is one of the core arenas in which it plays out. The outgrowth brought about by globalization, namely outsourcing, has further increased the need for global supply chain regulatory compliance.
Global supply chain regulatory compliance has now become something on which organizations cannot compromise. Any shipment of any item that reaches foreign shores can get rejected if it has not met global supply chain regulatory compliance. Such a consignment could even get labeled as counterfeit. This explains the importance and need for global supply chain regulatory compliance. Being in global supply chain regulatory compliance means adhering to even the local laws of the foreign country into which goods and products are exported.
Governments have become more stringent 
As a result of these trade and technological developments; governments all around the world without exception are jumping on the bandwagon to formulate laws that apply to the supply chain industry. For most governments, global supply chain regulatory compliance is a must. They are becoming extremely strict in enforcing these laws and are handing out severe punishments to businesses and organizations that are lax in enforcing global supply chain regulatory compliance. Most countries are legislating laws regarding global supply chains almost exclusively, in a way that other political acts are framed. This has pushed the need for global supply chain regulatory compliance further.
Other related developmentsAs technologies advance in the global supply chain, many developments in auxiliary and supplementary fields have hastened global the push for supply chain regulatory compliance requirements. For example, heavy paperwork, which used to be hallmark of most merchandising businesses, has made way for automation. Global supply chain regulatory compliance has to take factors such as these into consideration.
Other developments in allied areas such as intellectual property rights have gone on to strengthen the role of global supply chain regulatory compliance. As countries demand greater protection for their intellectual property products, they use global supply chain regulatory compliance as an instrument to enforce these, when these products concern exports.
In addition, there could also be other critically important issues in global supply chain regulatory compliance that may not be related to any of these, but can play a decisive role in disrupting global businesses. Think of natural disasters such as the Fukushima earthquake or the many natural disruptions such as hurricanes in South and North America. These could throw businesses out of gear. Global supply chain regulatory compliance is a kind of insulation against the uncertainties caused by events such as these.
In other words, global supply chain regulatory compliance should leave no stone unturned. There is no scope for compromise of any kind in implementing global supply chain regulatory compliance provisions.

Items that go into global supply chain regulatory complianceMeeting global supply chain regulatory compliance requirements means having to take care of a number of ingredients. Some of these are:
Upcoming crucial global supply chain regulatory compliance regulation in the USSeveral legislations aimed at bringing about global supply chain regulatory compliance are in place. However, at this point of time, a really crucial global supply chain compliance regulation that could play a major role in the US in the coming years is the Automated Commercial Environment (ACE).
In a nutshell, this U.S. Customs and Border Protection (CBP)-mandated regulation aims to bring in place a single portal which will make information on imported goods flow electronically from the businesses themselves right to the respective departments or agencies that require and handle them. The ACE is aimed at making import and export related work paperless, while also seeking to become a major facilitator of trade.

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Why Trade Compliance and Logistics Must Work Together

Trade compliance and logistics must work together for a number of important reasons. While on the surface, trade compliance for logistics may seem burdensome for many organizations, the benefits of getting their trade compliance and logistics to work together are multifold and far outweigh the short term effort that goes into it, and that of noncompliance.
Undoubtedly, the most important reason for which trade compliance and logistics must work together is that they ensure that there is compliance with the laws of the countries into which the goods travel. It is a lot easier and a lot uncomplicated to have goods moving within national boundaries, where one can expect familiarity with the rules and the operating environment. In the case of global trade, the story is different.
Need to grapple with multiple laws
There is great diversity and complexity of laws that govern trade compliance and logistics. They are now more integrated than at any point of time before because of the advent of new technologies. This brings in a motley mix of the elements of global business, such as currencies, laws, locations, people and so on. Businesses that have a stake in the global trade have to deal with these varieties and diffuse elements. One of the surest ways of ensuring that these are managed rightly is by getting trade compliance and logistics to work together.
Since there is a multitude of international laws that need to be complied with at many stages of the global supply chain; trade compliance and logistics must work together. This is the only sure way of ensuring that the company’s goods and products meet the required international trade guidelines and reach their destination safely.
A way out of the complexity
For many in the business of exports, complying with the global supply chain may seem complex. However, knowledge of the laws of respective countries and building a sound logistics and supply chain infrastructure will go a long way in mitigating the problems associated with these. This is why trade compliance and logistics must work together.
Imagine a consignment of textiles originating somewhere in the Middle East headed for North America. This consignment has to pass through a few countries, at each of which it has to be sure it meets the compliance requirements. Finally, even when it reaches its destination, it must ensure that the laws of that country are complied with.

Increased efficiency and enhanced reputation  Another important reason for which trade compliance and logistics must work together is that there are substantial long term gains to be had by doing so. Supply chains that have come about as a result of trade compliance and logistics working together become more reliable and efficient. All these mean reduced costs in the long run, increased customer satisfaction, and enhanced reputation in the business.
Elaborating on the point above, it is also equally true that trade compliance and logistics must work together to pump up nations’ economic growth. A country that ensures that trade and logistics are in accordance with internationally legislated laws on the subject are more likely to be trusted by global businesses. Countries in which trade compliance and logistics work together and result in sound business infrastructure are naturally more preferred by businesses as transit routes or destinations for their products. This brings in substantial revenues to the countries.

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What is logistics and supply chain management?

Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.
Logistics and supply chain management is emerging as a major area of business because of the evolution and growth of globalization. Many products and goods are produced in one country and consumed in another situated thousands of miles away. The right logistics and supply chain management helps to deliver the goods and products to the right person, at the right time, at the right place and in the right condition. Lack of proper logistics and supply chain management is a recipe for disaster.

What is logistics and supply chain management?

Among the lay people, there is a tendency to use the two words synonymously and interchangeably. In trade, however, there are major differences between the two. Logistics is just a part of the supply chain. In simple, general and broad terms, one can understand the difference between logistics and supply chain in the following ways:
Logistics is a part of supply chain, meaning that it is a set of activities that are carried out within an organization. Supply chain, on the other hand, is the full set of activities that are carried out from start to finish, i.e., from the time it departs the organization that it is leaving till the time it reaches its logical destination. In this process, supply chain management involves the coordination and collaboration of many entities. In this sense, supply chain is a whole set of activities, of which logistics is only a part.
Another way of understanding logistics and supply chain management 
Another way of understanding logistics and supply chain management is this:
Logistics can be understood as being a discipline in which the following activities are involved:

On the other hand, supply chain management can be said to include more extended activities, which include:
Logistics and its extended activitiesLogistics often is described in terms of inbound and outbound logistics. Simply put, inbound logistics is the movement of raw materials and goods that are bought by and transported into a company. When these are processed and finished and shipped to customers; they become part of outbound logistics.
Logistics and supply chain management in a broader contextWhen one tries to get an understanding of logistics and supply chain management at a higher or broader level in the way logistics has been described above; supply chain management can be understood as consisting of these elements:
A sound supply chain system seeks to create value for the organization by building and utilizing logistics infrastructure. Logistics and supply chain management become meaningful when the organization synergizes demand with supply, stock and supply and inventory management

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The Foreign Corrupt Practices Act – a look

The Foreign Corrupt Practices Act, or the FCPA, was enacted by the American Congress in 1977. Its primary purpose is the prevention of bribing of foreign officials to favor their business interests. In particular, the anti-bribery provisions of the Foreign Corrupt Practices Act prohibit using mails or other such means of communication to seek favors and making payments of money or other articles of value with the intention of obtaining favorable terms of business.
The purview of the Foreign Corrupt Practices Act is extensive in that even though it directly concerns foreign officials, any national or domestic official who belongs to the US can also be hauled up if he or she is found to have any level of involvement in dealings considered illegal by this Act.
The Foreign Corrupt Practices Act sought to correct the transparency requirements of the earlier Securities Exchange Act of 1934. The Foreign Corrupt Practices Act has undergone two major amendments, one in 1988, and the other, a decade later.
To whom does the Foreign Corrupt Practices Act apply?The Foreign Corrupt Practices Act applies to a number of individuals and entities. It applies to a person who has a business dealing with some business, individual or official in the US, even if that entity is not present in the US.

People subject to the Foreign Corrupt Practices ActThe Foreign Corrupt Practices Act considers the following entities as being subject to its purview:
Effect of the implementation of the Foreign Corrupt Practices ActThe Foreign Corrupt Practices Act has brought to book many malpractices in the American corporate sector and has penalized enormous amounts of money on offending individuals or organizations in some cases. The heaviest penalty it levied was on Siemens, which was forced to pay close to half a billion dollars for its offences relating to the Foreign Corrupt Practices Act. This is just one of the many cases the Foreign Corrupt Practices Act has settled, awards and penalties of all of which have run into billions of dollars.

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The FDA Export Reform and Enhancement Act of 1996 – a brief understanding

The FDA Export Reform and Enhancement Act of 1996 is a landmark Act passed by the American Congress. A landmark legislation in that it instilled and reinforced the concept of free global trade; the FDA Export Reform and Enhancement Act of 1996 removed the need for American pharma companies to obtain FDA approvals for the products that they export to select markets. Following the passage of the FDA Export Reform and Enhancement Act, American companies need to only get approval of the respective countries regulatory authorities.
One of the highlights of the FDA Export Reform and Enhancement Act of 1996 is that it was one of the very few Acts that were put into effect almost immediately after being passed into law. This perhaps reflected the immediacy of the benefit the Act wanted to bestow on American companies.
The overriding highlight of this legislation is that it almost totally obviated the need for FDA approval for products that were being exported to a few select countries. American pharmaceutical companies saw this as a great concession that they got to export their products, as it completely helped them bypass the tedious FDA approval process.
The FDA Export Reform and Enhancement Act of 1996 allowed the following categories of non-FDA regulated products to be exported to any country of the world:

• Any unapproved new drug
• Human biological product
• Animal biological product, or
• Medical device

The Listed Countries

Subject to marketing approval by the respective regulatory bodies of the 25 developed nations; American companies can market their products to what the FDA Export Reform and Enhancement Act of 1996 considers “Listed Countries”:

• Australia
• Canada
• Israel
• Japan
• New Zealand
• South Africa
• Switzerland, and
• The European Economic Area

Requirements of the FDA Export Reform and Enhancement Act of 1996The FDA Export Reform and Enhancement Act of 1996 prescribes vastly liberalized general requirements which pharma companies need to adhere to in order to be able to export non-FDA approved medical products to the Listed Countries. The following core components have been greatly relaxed or exempted for export approval:

• 510 (K) requirements for Class I and Class II devices
• GMP requirements
• Simple Notification
• Devices that carry imminent hazards
• Labeling requirements

Requirement from receiving countriesFinally, the FDA Export Reform and Enhancement Act of 1996, upon the insistence of the Listed Countries, ruled that manufacturers who wanted to benefit from this legislation had to obtain clearance from the FDA that there were no regulatory or legal actions pending on these companies.

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Effective Complaint Handling Guidelines serve as a basis for improvements in medical devices

Far from being frowned upon, complaints should serve as an opportunity for medical device manufacturers to understand the customer’s expectations better and lead to improvements in the product quality.
The FDA describes a complaint as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution”.
FDA’s complaint handling guidelines are critical for ensuring that an organization maintains safety with regard to the medical devices they manufacture. Errors in medical devices can result in complaints, and improper handling of complaints can lead to problems for the patient, ranging from injury to fatality.
It is to prevent these problems that the FDA has issued complaint handling guidelines. FDA’s thinking is based on the reasoning that a complaint may be an indicator of serious safety, but implementing effective complaint handling guidelines can greatly mollify the gravity of the issue. It is also the first step to initiating new product development, which in turn has the potential to greatly reduce risks associated with noncompliance.

Regulations in place

Provisions relating to effective complaint handling provisions are contained in FDA 21 CFR Part 820 and GxP regulations.
Firstly, these complaint handling guidelines require medical device manufacturers to maintain complaint files. Manufacturers have to make this the first step towards establishing a sustainable complaint management system.
Secondly, Section 198 of Part 820 warrants the following:

Thirdly, FDA 21 CFR Part 820 requires the manufacturer to establish and maintain procedures for the receipt, review, and evaluation of complaints.

What should records of investigation contain?

Records of investigation should contain the following:

• Identifiers related to the device and reported event
• If Medical Device Reporting is made, it should investigate the following:
  • Whether there were any specifications the device failed to meet
  • Whether it was for treatment or for diagnosis that the device was being used
  • In what way the device was related to the reported event, if applicable

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Business Process Management in Healthcare helps reduce inefficiencies

For many years before the advent of automation and computerization ,healthcare processes, such as billing, admissions, and many elements of care were carried out manually. Although it was a capable method to quite an extent, it relied on the use of the manual process or the human method. This was always prone to mistakes and errors, because humans are prone to committing errors that can creep in even with the best of intentions, as a result of which the healthcare industry ended up losing billions of dollars that could otherwise have gone into meaningful forms of investment.

A result of technological developments

This is why Business Process Management (BPM) in Healthcare came into existence with the advent of and as a byproduct of automation. Business process management in healthcare is being considered a major step in helping healthcare settings reduce costs and inefficiencies. When a unit implements business process management in healthcare; there is an automatic reduction in errors and inefficiencies. Let us see how:

Impetus from the higher authorities

There is now a general tendency and effort to push for automation in the healthcare industry. Even the American Congress has been aggressively pushing for reforms in the healthcare industry, a prime feature of which is fostering business process management in healthcare. Overall, BPM in healthcare is a means for improving efficiencies throughout the healthcare chain and bringing about greater integration and accountability through automation.

Core areas of business process management in healthcare

Business process management in healthcare is useful across the healthcare process chain, but is particularly so in at least there important areas:

Billing:This is one of the prime areas in which business process management in healthcare can make a huge difference. With complete automation of this critical area of business, healthcare units ensure that there is total coordination and traceability of the billing process. Software:Apart from billing, another area in which business process management in healthcare helps tremendously is software. Software applications can bring about a huge change in the speed of operations. This area of BPM in healthcare reduces the need for human intervention at various stages of the business process.
Big data:Another of the areas in which business process management in healthcare holds huge promise is big data. Big data can help to make sense of various data used in healthcare administration and disease management across entire geographies. This makes the role of business process management in healthcare all the more meaningful and exciting.

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Digital Marketing for Pharmaceutical companies offers tremendous opportunities

There is enormous potential for digital marketing for pharmaceutical companies. Proper exploitation of the social media can take pharmaceutical companies to their market in a more pinpointed and accurate manner than traditional marketing.
Gone are the initial days of reluctance on the part of pharmaceutical companies to embrace social media as a powerful marketing medium. That was in the past, when the concept of social media was new, and regulations in the pharmaceutical industry had yet to catch up with explosive pace at which the social media grew.

More and more pharmaceutical companies are on the social media

Today, one is likely to see any pharmaceutical company worth its name being active on YouTube, Facebook and Twitter to interact with its customers. Changes brought about by digital marketing in the pharmaceutical industry have seen companies like Johnson and Johnson and Pfizer being among the several majors associated with YouTube lately for creating and promoting their image. This is a result of the realization that social media can, far from being unconducive to the industry, can be quite amiable to it.

• In a study in late 2014, the New England Journal of Medicine estimated that leading pharmaceutical companies spend up to a quarter of their marketing budgets on the social media
• The study pointed out that the social media were as powerful and effective as EHRs and mobile applications as marketing tools, signaling a new dynamic for digital marketing in the pharmaceutical industry.

Social media as a key differentiator

The defining area in which the social media can be different and more effective than traditional marketing tactics for pharmaceutical companies is this: earlier methods such as trade conferences, promotions, gifting doctors for prescribing a company’s brands were effective, but were carried out outside the healthcare setting and in isolation of the patient. The reach and intervention of the social media has made digital marketing for pharmaceutical companies so much more effective that they can get right into the arena of treatment and be of assistance with valuable inputs and suggestions.

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Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU's regulatory body, the MDD.

The Design History File

The history of the Design History File is an interesting one. It evolved out of the FDA's realization, over time and experience; that the major part of a device's problems was happening during the design stage and change phases, regardless of whether it was a new product or a changed one. This led to the birth of the concept of Design Control, aimed at tracking, monitoring and correcting the design elements at every stage from start to finish.

Outstanding characteristics of the Design History File

What should the Design History File contain?

The DHF should contain the following:

Now, the Technical File and Design Dossier

In short and simple terms, one can understand the Technical File and the Design Dossier as the EU's version of the Design Control and the DHF. In other words, what Design Control and Design History File are for the FDA; the Technical File and Medical Device (MDD) are for the Medical Device Directive.

What should the TF and DD contain?

These files should have all the basic sections needed to support the requirements of the Medical Device Directive (MDD), Essential Requirements (for that product), and the company's "Declaration of Conformity" for that product:

• General Information/Product Description/EC Authorized Representative
• Classification Determination
• Essential Requirements
• Risk Analysis
• Labeling
• Product Specifications
• Design Control
• Clinical Evaluation
• System Test Reports
• Functional Bench Testing
• Lab Testing
• Sterilization validation (or AAMI TIR 28 Analysis)
• Packaging Qualifications
• Manufacturing
• Sterilization
• Conclusion
• Declaration of Conformity
• Appendix

Differences between the Technical File and Design Dossier

At a broad level, in general terms, while the Technical File is for MDD Class I and Class II a or II b; the Design Dossier is for MDD Class III devices
While Technical Files are retained in the premises of the manufacturer or the Authorized Representative for review of the Competent Authorities or/and Notified Body; Design Dossiers need to be submitted to the Notified Body for review before the product gets its CE-marking.

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Design Control for Medical Devices

Design Control for medical devices is of utmost importance to the medical device industry. In order to get a grasp of its importance, one needs to get an understanding of what Design Control is. In simple terms, Design Control for medical devices is a set of logical and linear steps that medical device manufacturers have to take to ensure that:

1. The medical device being manufactured is safe
2. The medical device manufacturer follows all the steps and procedures for ensuring that the device it develops is what was meant to be developed
3. Design controls for medical devices have to be put in place to ensure that the final product – the medical device – meets all the required and prescribed regulatory procedures and guidelines and meets the customer’s expectation

In short and simple terms, design controls for medical devices are verifiable and provable assurances that medical device manufacturers have taken adequate steps to guarantee that a medical device meets its set of required standards and procedures to ensure its safety and meet customer requirements.
FDA and ISO expectations of design controls for medical devicesBoth the FDA and the ISO have regulatory requirements from medical devices that expect some Design Control standards. The FDA’s requirements for design controls for medical devices are spelt out in FDA 21 CFR 820.30, while ISO 13485 is the standard for design controls for medical devices. Although formed by different regulatory or standards bodies; both the FDA 21 CFR 820.30 and the ISO 13485 are essentially similar. Their purview of the areas of design controls for medical devices is almost identically similar to each other. Sections of the FDA 21 CFR 820.30 and the ISO 13485 speak of requirements relating to the following in their various sections:

• Design and development planning
• Design output
• Design input
• Design review
• Design verification and validation
• Design transfer
• Design changes.

In just one area of design controls for medical devices, namely Design History File, there is a small difference, in that while the FDA’s regulatory requirements for design controls for medical devices include DHF; in the case of the ISO 13485, this is treated separately. There is thus near total convergence between the FDA 21 CFR 820.30 and the ISO 13485 when it comes to design controls for medical devices.
Basic requirements of FDA 21 CFR 820.30 and ISO 13485Both the FDA 21 CFR 820.30 and the ISO 13485 have expectations for design controls for medical devices. These are the core areas:

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Aspects of Regulatory History in the US

The beginnings of all that the USFDA regulates can be traced right to the early decades of the founding of the nation. In a sense, the FDA, even if came to be called by that formal name much later; embodies the discipline and value set that the new created nation sought to represent. Regulation of all aspects of American life was deeply ingrained very early in the nation’s history, and the FDA was one of prime institutions that played a part in making this happen.
How has the FDA evolved and shaped up over the years? What are the important milestones of this history? This makes interesting reading, because the USFDA has had the kind of history whose colorfulness is matched by few other regulatory agencies around the world.
An indication of the extent to which the FDA attaches importance to ensuring the wellbeing of the American people can be gauged from the fact that the food and other products that this agency regulates account for a fifth of the total money that the nation’s consumers spend. Just its budget – well over four billion in 2014 – is a good indicator to the way in which the FDA has spread its influence in the various spheres of American life. It regulates almost all food items with the exception of meat and poultry.
This situation has not been reached accidentally or overnight. The FDA has by and large kept pace with the developments in the areas it regulates. This was largely true till the advent of very recent technology-led areas such as biotechnology and the social media, where too, the FDA has been trying to put its best foot forward.
The start of formal regulation 
A look at the history of the FDA points to the year 1848 as the start of the first formal aspects of regulatory history. That was the year in which Lewis Caleb Beck took his appointment with the Patent Office. His mandate was to chemically analyze agricultural products. This is considered as the first task that was aimed at regulating a product that people consumed. This function rolled over to the Department of Agriculture, which was created in 1862.
The Act of 1906The next step in solidifying the regulatory aspects of life in the US was taken in 1906, with the promulgation of the Pure Food and Drugs Act in 1906. Stretching to some two decades of wrangling between the American Congress and the food industry to formulate, the Act of 1906 sought to prohibit adulterated and misbranded food and drugs from interstate commerce.
The 1938 Food, Drug, and Cosmetic ActThe next major milestone in the aspects of regulatory history in the US took place in 1938. The 1938 Food, Drug, and Cosmetic Act prescribed and detailed the legal requirements for products the FDA – which this Act created – regulated. In this Act, one can trace the earliest tidings of a major activity that the FDA has been carrying out since then: Prescribing the requirements for ensuring quality by prohibiting false claims by manufacturers and advertisers.

President Franklin D. Roosevelt signing the 1938 Food, Drug, and Cosmetic Act. Over time, the 1938 Act expanded to include more areas such as cosmetics, devices and veterinary medicines, thus strengthening the foundation for regulation and making it more expansive. Since the passage of the 1938 Food, Drug, and Cosmetic Act; two major events happened on the regulatory scene. The outbreak of tetanus and diphtheria diseases in the 1960’s compelled the FDA to take a more proactive approach to vaccinations.
Another major, earthshaking event was the tragedy that thalidomide unleashed on Europe in the 1960’s, which stunted the growth of hundreds of children, which was mainly due to regulatory lapse. This did not happen in the US, mainly because of the efforts and diligence shown by Frances Kelsey, in her role as FDA reviewer. Frances plainly refused to approve thalidomide because she was not convinced about its safety, an act which made her a cult figure in FDA and American and Canadian medicinal history till her death in 2015.

Aspects of regulatory history in the US in the 1990’sFollowing the 1960’s, the next major milestone in the aspects of regulatory history in the US happened in 1990, when the Nutrition Labeling and Education Act was passed. This law was important because it changed the American perspective of labeling of products in the food and pharmaceutical industries. The Nutrition Labeling and Education Act requires manufacturers to provide nutritional information about products on their labels, with the caveat that false labeling information will lead to consequences.

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Good Documentation Practice Guideline is simple: just write

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.
Good Documentation Practices are essential for a number of disciplines. The soul of documentation is, naturally, the written word. What happens when something that happened is not actually written down? It is a work of no practical use, because apart from those that carried out the particular undocumented task; no one else is aware of it. And even when the people who did that task or were witness to it are prone to have their own interpretation and perception of what was done. This is why proof in the form of writing is the most important element of Good Documentation Practices.

What to write, and how toGDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FDA. This enables everyone concerned, from the people in the organization to the auditors to the regulatory agencies, to clearly identify what action was carried out, by whom and when. This further leads to a discovery of the impact of the actions. This is the key to determining the effectiveness of the application of the GDP principles in the particular case.
This is why the FDA has very clear-cut requirements and expectations of GDP from the industries it regulates. These clearly explain the method by which to document the said document, the ways of doing it, and what actions to take when the need arises.
Quality Assurance is unthinkable without the application of GDP principles. The main reason for establishing GDP is ensure that the documentation does the following to the record in question:

What needs to be documented?Another major element of GDP is to determine what is to be documented. The FDA and other regulatory agencies require the principles of Good Documentation Practices to be applied across a number of activities at different stages. These include:

The EMA’s requirements
The EMA also has clear-cut guidelines on Good Documentation Practices. Some of its core requirements relate to

• Specifications
• All aspects of the manufacturing including the product’s formulae, the way in which the processing was done, the methods of its packaging, and the extent to which its testing instructions are written down
• SOPs
• Protocols
• Technical agreements

Further, most regulatory agencies have their own requirements with regard to the styling, ways by which the amendments, if any, need to be jotted down, the type of ink to be used, the way in which the review, if any, needs to be entered, and who should put signatures and where, so on. Manufacturers who fall under the purview of respective regulatory agencies need to adhere to these.
And, for other reasons, as wellImplementing Good Documentation Practices is a great idea to have for meeting regulatory requirements, because companies that do not meet these requirements are in a spot of bother about a number of issues. However, in addition to this, there is also the need for maintaining GDP for business reasons, as well. A business that complies with the requirements set out by the FDA or other regulatory agencies in relation to Good laboratory practices, the CFR regulations such as 21 CFR Parts that apply to various industries, and also as required as part of national and global agencies; earns a good name in the market and is considered a reliable company.

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What is risk-based monitoring?

Sponsors of clinical studies adapt many methods that are aimed at reducing the complexity of clinical trials. They also look for methods by which they can increase the efficacy of the results, while keeping the costs low. Risk-based monitoring is one of these methods.
How is risk-based monitoring understood?One can understand risk-based monitoring in several ways. This varied understanding is because there is no one definition or application of this concept. Risk-based monitoring is a method of evaluating and preventing risk in a clinical trial. This broad definition of course, conceals more than it reveals, since risk-based monitoring can happen in a number of ways and can be applied in a number of areas concerning the clinical research.
FDA and EMA guidelines on risk-based monitoringIn 2011, the FDA, as well as the European Medicines Agency (EMA) their respective sets of draft guidance aimed at helping sponsors of clinical research get a better understanding of the regulatory requirements and obligations for the conduct clinical trials using risk-based monitoring. However, these guidelines were not specific. Moreover, they did not make any procedure or methodology or rule relating to risk-based monitoring mandatory. Since these guidelines on were more or less prescriptive and suggestive by nature; they did not address the core issue relating to risk-based monitoring, leaving the topic rather hazy.
Since this is the current state of risk-based monitoring regulations, most clinical trials sponsors have stuck to the traditional mode of risk-based monitoring. These generally include:

The importance of cloud technology to risk-based monitoringSince all these are generally disparate from each other; risk-based monitoring has now required more and more extensive use of technology that will enable his. Risk-based monitoring has now increasingly become technology-driven and technology reliant. As new technologies such as the cloud gain more acceptance; risk-based monitoring has grown with it, since it will help keep track of the various activities at various levels and helps integrate these in real time.

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FDA Warning Letters – an understanding

As the primary regulator of the biological, healthcare, life sciences and other related industries; the FDA has power and authority over how its work is carried out. FDA Warning Letters are among the primary mediums through which it enforces its authority.
The FDA issues a Warning Letter to a company when it determines, following its inspection of a facility from an industry that it regulates, that the facility is violating some or other terms of the provisions of the FDA Act. The FDA Act is a legislation that gives the FDA the authority to carry out its inspections.
The issuance of an FDA Warning Letter is an indication that the facility is practicing some degree of nonconformity. A Warning Letter is among the FDA’s strongest tools of ensuring voluntary compliance from organizations with the provisions of the FDA Act.
The FDA publishes on its website any deviances of regulatory significance that it discovers from a facility during its investigations. In its viewpoint, a deviation of regulatory significance is one that leads to enforcement actions if the facility fails to carry out corrective action of whatever violations the FDA has documented.
Types of Warning Letters from the FDATo enable the public and concerned parties to view the Warning Letters it issues from time to time; the FDA has classified these on its website in the following manner:
A General Warning Letter is one that is issued to a company in whose activities the FDA notes significant variations from the principles laid out in the FDA Act. The Warning Letter carries a description of the variation or violation that the manufacturer has been practicing, along with a description of what actions needs to be taken to correct it.
Tobacco Retailer Warning Letters are those that are issued to manufacturers of products made out tobacco, such as cigarettes, smokeless cigarettes and related ones, who are found to be violating the provisions of the FDA’s Tobacco Control Act and with provisions of Title 21 of the Code of Federal Regulations, Part 1140 (21 C.F.R. Part 1140).
Drug Marketing and Advertising Warning Letters (and Untitled Letters to Pharmaceutical Companies) are those Warning Letters that the FDA website sorts out by month and consist only of Division of Drug Marketing and Communications and Drug Warning Letters. This kind of Warning Letter is issued to sellers of prescription drugs online when they are found to violate terms set out by the FDA.

Warning Letter closeout program
When the FDA issues a Warning Letter to a facility that comes under the various classifications; it follows up with it from time to time to ensure that the suggestions it advises are carried out. When the facility has carried out the necessary corrective actions; the FDA issues the Warning Letter Closeout, which closes the matter associated with the Warning Letter until the next FDA inspection. Methods of issuing Warning LettersIt is only when it discovers violations that the FDA issues Warning Letters. It is through inspections that it discovers violations, from which Warning Letters follow. However, the FDA can also issue Warning Letters to facilities about which its receives complaints of wrongdoing from state personnel.
An FDA Warning Letter is not an enforcement action
In the perspective of the FDA; a Warning Letter is of an informal and advisory nature. An FDA Warning Letter is a description of the violation observed at a facility; but this in itself does not make the FDA take enforcement action. Rather, through a Warning Letter, the FDA advices the organization on what steps it has to take in order to rectify and correct the reasons for which the Warning Letter was issued. An FDA Warning Letter offers the organization enough opportunity to take corrective action that is of a voluntary and appropriate.

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