Can Vendors Provide 'FDA Compliant' Software?
Vendors of software and computer systems frequently advertise their
products as 'FDA approved', 'FDA Compliant', 'Part 11 Compliant' or
'Certified for FDA Compliance". The questions is if such statements are
accurate. There is no doubt that companies and individuals with little or no
understanding of regulations and computer validation are impressed. They
purchase software and install it and expect to pass FDA inspections.
Computer validation professionals are not impressed by such statements,
even less FDA inspectors. Just the opposite happens: companies making such
statements are easily recognized as having little or no knowledge about
regulatory requirements. And FDA officials state that people need to
be wary of claims that a vendor may have that it is somehow FDA-approved.
'FDA compliance' does not only mean that software has the functionality, it
also means that the software and complete system is installed, validated and
operated in compliance with the regulations. This also means the operators
should be trained to use the software in FDA compliant manner. The best a
vendor can do is to state that the software has the technical functionality
that will allow the user to operate the software and system in compliant
Recommendations from an FDA/Industry-Training
This Question also came up during an FDA Industry Training back in 2003.
Question from the chairman: "Whenever there is a gap or a void in the
market somebody jumps in and sells something. So the question gets to be -
there are probably going to be, if there are not already, companies that
will sell you systems that will help a company to comply with part 11
through encryption and so on. Does the FDA improve or endorse any of those?"
Answer from the FDA official: "No we don't. We don't get into that
business. In the same manner that we don't approve or disapprove
specifically equipment that companies use to manufacture FDA-regulated
products. So people need to be wary of claims that a vendor may have that it
is somehow FDA-approved. I think the best thing that a prospective vendor
can do is simply compare and contrast the features that they have in their
product with part 11 requirements and let a prospective buyer make up his
(Labcompliance Usersclub members can
watch a video clip
with this quote
Recommendations from Labcompliance
- Users should write specifications for the intended system including
user requirement specifications and functional specifications, or
combine them in one document and call them system requirement
specifications. In preparation for this users can ask the vendor if they
can provide them with a list of functional specifications of the
- Users should include regulatory requirements in the specifications,
e.g., audit trail for 21 CFR Part 11.
- Users should ask the vendor to respond to the specifications list.
Answers related to regulations should include some statements on how
requirements are met or or how services are delivered.
- Users ask vendors about their software development processes and how
the software has been qualified during development. Special focus should
be on testing, because the more documented evidence of testing a user
has on testing at the vendor site, the less testing is required at the
- Users should ask vendors how they can assist a user during
validation at the user's site. This could be test scripts, SOPs or
services for complete IQ/OQ.
- For vendors we recommend to prepare a table with regulatory
requirements, e.g., 21 CFR Part 11 and a description of how each
requirement is built into the software or delivered as a service.
- Vendors should never advertise products as 'FDA approved' or 'FDA
compliant' While they may impress companies with little experienced in
computer validation, they will loose their reputation at more
knowledgeable companies. Instead include phrases like: "Has functions to
enable Part 11 compliance", "With built in functionality for GMP, GLP
and Part 11", "Part 11 Ready",
- Vendors should support their statements about functionality with a
functional specifications document and technical papers describing in
more detail how the functionality is built.
For more information on vendor/user relationship and to get SOPs on how
to qualify vendors and to get reference papers on vendor contributions, we
recommend to attend the audio seminars
Assessment of Software and Computer System Suppliers
to get the most out of Supplier Support for Equipment and Computer
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