Software as a Service, SaaS is a method of delivering applications
over the Internet. This small definition just about summarizes the core
of SaaS: It provides Software as a Service using just the Internet. SaaS
applications go by different nomenclatures such as on-demand software,
hosted software, or web-based software.
SaaS is a fundamentally different method of delivering applications,
because when a client chooses SaaS; there is no need to install and
maintain software. It can be accessed with just an Internet connection.
SaaS applications can be run on the provider’s servers. Since it is the
provider who takes over the responsibility of managing all aspects of
the application, such as making it available and secure, and also for
its performance; the client is spared the headache of having to manage
unfamiliar and often complex software and hardware.
This sunny side of SaaS appeals to many clients, which is the primary
reason for which SaaS is a huge market. From over $ 10 billion in 2011
in the US; the global SaaS market is set to grow to around $ 120 billion
by 2019. Speculated to grow at a CAGR of anywhere between 18 and 24
percent; SaaS is estimated to make up more than one fifth of all
software services by that year.
The difficult side of SaaS
This makes the prospects for the SaaS market very bright. However,
there is a catch: Most SaaS providers outsource their resources to cut
costs. This activity exposes them to the seamy side of this exploding
market. Most
regulations such as 21 CFR Part 11 are only for the provider,
and very little of these are for the vendor. Since there is very less
regulation that will offer safeguards to the user from the vendor; the
onus of ensuring compliance for both infrastructure qualification and
Computer System Validation lies with the regulated company, for it is
they who have to show compliance with the regulations and prevent issues
relating to availability, performance and protection of data.
Failure in doing so hurts their reputation, because it is they, and
not the vendor, that is regulated. This regulated provider is the one
that becomes the target of FDA inspections on software validation and
should hence do everything it can to avoid FDA actions such as Warning
Letters and 483’s. There is thus a major need for regulated companies,
software vendors and SaaS/cloud providers to show
compliance with 21 CFR Part 11 and other regulations such as Annex 11. This is the only way to avoid legal and other issues associated with noncompliance.
Learn the ways of staying compliant
How do regulated companies, software vendors and SaaS or cloud
providers ensure compliance and safeguard and enhance their reputation
as trustworthy providers? It is this critical issue that will be
discussed threadbare at a very useful and educative two-day seminar that
is being organized by GlobalCompliancePanel, a highly regarded provider
of professional trainings for the regulatory industries.
At this seminar, David Nettleton, who is an industry leader, author,
and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation,
and Computer System Validation, will be the Director.
Want to understand how David explains the way by which regulated
companies can offer legally compliant SaaS and cloud solutions? Then
please register for this seminar by logging on to
Understanding 21 CFR Part 11 compliance for software validation and SaaS/Cloud.
This seminar has been pre-approved by RAPS as eligible for up to 12
credits towards a participant’s RAC recertification upon full
completion.
Demonstrating proven techniques
The purpose of this seminar is to demonstrate proven techniques for
reducing costs associated with implementing, using, and maintaining
computer systems in regulated environments. Towards imparting this,
David will address the latest computer system industry standards for
data security, data transfer, audit trails, electronic records and
signatures, software validation, and Computer System Validation.
With the
FDA performing both GxP and Part 11 inspections;
the EMA has released an updated Annex 11 regulation that expands Part
11 requirements and companies must update their systems and processes to
maintain compliance. David will discuss this. He will give participants
an understanding of the specific requirements associated with local and
SaaS/cloud hosting solutions.
Validation in a number of specialized areas
Since almost every computerized system used in laboratory, clinical,
manufacturing settings and in the quality process has to be validated;
the ways by which they can decrease software implementation times and
lower costs using a 10-step risk-based approach to
Computer System Validation will be imparted.
The Director will review recent FDA inspection trends and discuss how
to streamline document authoring, revision, review, and approval.
Anyone who uses computer systems to perform their job functions in
the regulatory, clinical and IT areas of health care, clinical trial,
biopharmaceutical, and medical device sectors will find this seminar
highly useful. It is of high value for software vendors, auditors, and
quality staff involved in GxP applications.
