Quality System Regulations are general guidelines that need to be customized

Key Takeaway:

The FDA's Quality System Regulations (QSR) are a family of wide-ranging regulations meant for a number of industries, as well as a number of medical devices. They need to be applied using the manufacturer's discretion on what constitutes a state-of-the-art practice.

The FDA has issued Quality System Regulations (QSR). The objective of putting in place Quality System Regulations is that they must be used as the guidelines by manufacturers to establish that their products meet appropriate specifications and requirements consistently.

These are issued alongside medical device Good Manufacturing Practices (GMP). The reason for this is to fortify the practices related to the two disciplines and related ones. The Quality Systems (QS) of the following FDA regulated industries are jointly called Current Good Manufacturing Practices (cGMP's):

• Food
• Drugs
• Biologics, and
• Devices

Umbrella approach

The important premise on which quality systems regulations are built is that a quality system has to contain broad guidelines that can be used across the industries for which they are formulated. 21 CFR 820 of the QS regulation thus has expansive guidelines for covering all these designated industries, and require their selective and subjective interpretation from manufacturers to select the one that suits them best. QS Regulations are, in this sense, a kind of canopy under which these industries have to operate their respective guidelines and best practices.

The FDA states that since their Quality System Regulations have what it terms an "umbrella approach" in that it applies to a swathe of industries and devices; it does not prescribe in very great detail the way in which a manufacturer has to produce a particular device. Rather, it requires manufacturers to develop and follow procedures and then fill up details in consonance with the latest or current state-of-the-art manufacturing for that particular device.

FDA's 21 CFR 820 of the QS regulation's broad guidelines

These are some of the broad areas that are covered in 21 CFR 820:

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Risk-Based Computer System Validation is a remedy to expensive and time-consuming computer system validation methods

Key Takeaway:

Organizations that implement a risk-based approach to computer system validation decrease, in the long run, time and cost overruns associated with validation.

Computer system validation is a must for organizations involved in a number of businesses and activities. Regulatory authorities such as the FDA, apart from the European Medicines Agency (EMEA), Medicines and Healthcare Products Regulatory Agency and the Ministry of Health, Labor and Welfare (MHLW) of Japan exhort organizations under their purview to implement a risk based computer system validation.

Yet, there is general widespread reluctance about its implementation, because many organizations are concerned at the apparent high costs associated with risk based CSV. Many are fine with the general, mechanical elements of CSV, such as implementing methodologies, processes and documentations, but are somehow loathe to the idea of implementing a computer system validation that is risk based. Most of the reservations organizations have are centered on:

• Lack of clarity about standards to be implemented or their overlap
• Lack of a robustly structured quality system
• Existence of myriad interpretations and opinions
• Low or total lack of exposure to CSV
• Perception of low returns and immeasurable improvement in quality on relatively high investment

Despite all these skepticisms, a risk based approach to computer systems validation is considered a vastly improved methodology over the traditional system of validating everything for everything. With the coming into existence of21 CFR Part 11; there has been a shift in focus from validating everything to validating the core, critical aspects of CSV.

Why a risk based approach to CSV?

The need for importance of a risk based approach to computer system validation has to be understood from the following standpoints:

Principles of risk based computer system validation

Risk based CSV is primarily run on two major principles:

Risk based CSV involves inputs of some additional costs in the short run, but the organization that implements it gets its risk identification, assessment and mitigation right and saves in the long run.

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• Fda
• Regulatory Compliance
• Computer System Validation

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  Written by

  Ronald Gardner

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Diligence should go into Software Validation Process for 21 CFR Part 11

Key Takeaway:

Software Validation Process for 21 CFR Part 11 is all about authenticity and integrity of electronic signatures and records. Care should be taken to avoid confusion and get validation right.

The FDA's Code of Federal Regulations (CFR) is a collection of laws that regulate the various government agencies. Different titles of the CFR govern respective regulated areas.

What is 21 CFR Part 11?

Codes contained in21 CFR Part 11 relate to electronic records and approval signatures, which are digital versions of paper documents and handwritten signatures. 21 CFR Part 11enables

• A paper record to be replaced by an electronic record
• Any handwritten signature to be replaced with an electronic signature
• The software of these systems to be validated, so that the authenticity of electronic signatures can be proven
• An organization to implement good business practices.

Why is software validation process for 21 CFR Part 11 necessary?

With the widespread proliferation, reach and prevalence of the use of computers; it is a given that people would like to use electronic records instead of paper records. CFRs became necessary as records graduated to the electronic format, because of which validation of these signatures for their authenticity also became necessary.

An intrinsic part of SOPs

The software validation process for 21 CFR Part 11 is enshrined in the regulated company'sStandard Operating Procedures (SOP's), which describe the way in which processes are to be performed. In the course of implementation of the software validation process for 21 CFR Part 11; any paper record, inclusive of signatures, is to be replaced with an electronic one, given that the computer system is validated and has appropriate features.

Primary areas software validation process for 21 CFR Part 11 compliance

21 CFR Part 11 compliance consists of three primary areas:

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Supplier Evaluation and Internal Auditing are crucial for organizations

Key Takeaway:

There are many challenges associated with supplier evaluation and internal auditing, but compliance with QSR and ISO 13485 and diligence are the antidote to these.

In any organization, continuous and scientific evaluation is a must. This is all the more important for an FDA-regulated industry. Supplier evaluation and internal auditing are done to ensure that the intended quality standards are met on a consistent and continuous basis.

Features of supplier evaluation and internal auditing

• Both supplier evaluation and internal auditing are necessary and critical for almost any organization
• Supplier evaluation and internal auditing complement and supplement each other as separate, but deeply related programs
• The ways in which these two elements work are different, since they deal with different aspects of the quality process, but both supplier evaluation and internal auditing are intertwined.

Supplier evaluation

Supplier evaluation is a very critical aspect of almost every industry, since a majority of organizations -be they in pharmaceuticals, medical devices, software or any other - rely on external suppliers for many of their needs. Most raw materials are sourced from external parties. Since it is these raw materials that determine the quality of the final output; it is imperative for an organization to ensure that the raw material is of the required quality and up to industry standards.

Major challenges associated with supplier evaluation

Solutions for problems associated with supplier evaluation

Complying with QSR and ISO 13485 requirements for supplier selection and assessment is the answer to challenges associated with supplier evaluation. These standards have guidelines on:

Internal auditing

Internal auditing follows supplier evaluation. While supplier evaluation is about assessing the quality of raw material from an external party; internal auditing is a process in which:

• The material sourced from outside is audited from within the organization
• The internal auditing is also done for raw materials or other related materials not sourced from outside, but produced within the organization
• Products made out of raw materials procured from external sources are also audited internally

This consists of a series of stringent quality checks, since internal auditing is about how well the risks are mitigated.

Challenges in internal auditing

Way by which to address challenges of internal auditing

Unlike resort for CFR and ISO 13485, which act as effective safeguards against supplier evaluation issues; there are no such regulatory remedies for addressing challenges associated with internal auditing. It is left to managements to intuitively look for solutions to issues relating to internal auditing. Some of these can be looked into:

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