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’s Standard 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:
GxP in Computer System Validation.
GxP (Good X Practice, where according to FDA compliance; X can mean Clinical, Laboratory, Manufacturing, Pharmaceutical, etc., and used according to the situation in which they occur) in Computer System Validation occupies a position of primacy in the field of technology because of various reasons. The important ones among these are the heavy use of software in a wide range of medical activities, and the changing nature of computer technology, which has a deep impact on pharmaceutical devices and related products. Companies in these businesses need to ensure that the best practices in software are implemented mainly to keep abreast of the developments.
GxP in Computer System Validation has developed at a rapid pace of late because of the trend to integrate electronic records into manufacturing practices. While this has led to huge improvements as far as the speed of processing records is concerned; it has also brought in its wake a few inevitable challenges. .
Critical aspects of GxP in Computer System Validation
GxP in Computer System Validation consists of at least three extremely important aspects. One, GxP in Computer System Validation in the life sciences industry is not a monolithic and inflexible set of instructions. It consists of various rules and applications that need to be applied by companies according to their need and requirements. In other words, a generalized, “one size fits all” approach does not work for GxP in Computer System Validation.
Secondly, these validation requirements need to be implemented at various stages of the Software Development Lifecycle (SDLC). This means that medical device, pharmaceutical, life sciences and other related industries need to comply with GxP validation at every stage of development of the product.
Also, it goes without saying that compliance is mandatory. Noncompliance invites penalties, because GxP requirements set out by the FDA have the effect of the law.
Asking why Computer System Validation (CSV) is important in FDA-regulated industries is like asking why an engine is important to a vehicle.
Before going on to get an understanding of this issue, let us understand that there is a difference between the ways in which the term “validation” is used in the general area of computers and that used in FDA-related circles. In the field of computer science, the term means the ability of software to meet its stated requirements. For the FDA, validation of a computer system incorporates all activities that go into a computer system and these should be documented and made available to the FDA. We could use the word “verification” to associate the same meaning and understanding of what “validation” means to the FDA.
The critical importance of computer system validation in FDA regulated industries can be learned from at least two perspectives:
1. When a company is carrying out systematic CSV; it nips potential serious problems in the bud by preventing software problems from reaching production stages and environments. When a problem in a Life Science software application reaches the production environment, this can lead to serious adverse consequences. On the one side, there is the human element of getting the CSV validation wrong, which can result in serious product consequences, which can be disastrous to the patient’s health; on the other, businesses that get their CSV wrong can also face anything from lawsuits and heavy penalties to having to shut shop permanently. Long drawn out court cases can result in serious problems including bankruptcy.
2. FDA’s regulations requiring companies to carry out systematic CSV have the effect of law, which means that companies that come under the ambit of the FDA are legally bound to follow the guidelines set out by FDA’s regulations. When companies fail during an FDA audit; it can invite inspectional observations (“483s”) and warning letters.
The most important element of CSV that companies need to bear in mind is that they need to get their validation right alright; they also need to get it right stage by stage. Some companies have tried the short cut method of overlooking or circumventing a step or two. While this may give them short term savings; their long term costs are far higher than these savings.
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