3 Things to Know About CSV and Electronic Records

With so many electronic life science products on the market these days, it’s easy to focus on a process fit and implementation instead of details, like computer system validation (CSV) activities. If there isn’t a robust quality management system in place or the group is strapped for resources, validation activities for commercial products becomes a lesser priority. However, that’s an audit risk that life science companies should weigh carefully. Here are three things to know about CSV as it relates to 21 CFR Part 11.

1. The law requires validation.

According to 21 CFR Part 11 Section 11.10, closed computer systems that are used to modify, maintain or transmit electronic records must employ procedures to maintain authenticity, integrity and confidentiality of those records. Those procedures and controls shall include validation of those systems.

2. The law does not prescribe validation methods.

While vague and nonspecific, the law clearly states that some sort of validation must occur and that documentation should be kept in the event of an audit. Validation means different things to different life sciences companies based upon the system being validated, its intended use, whether it’s custom or commercial, and even the approach to validation. Historically, CSV has been a very document-heavy, long process based upon the classic V-model of the software development lifecycle (SDLC). Adapting CSV to fit agile implementation and SaaS products has proven difficult. That being said…

3. Change is coming.

A draft FDA guidance expected since 2019 and slated for release this year will introduce the FDA’s approval of shifting from CSV to CSA – computer systems assurance. CSA will allow companies to approach validation activities using a risk-based approach and focus upon intended use of the system. The point is to spend more time with unscripted testing and attempts to break the system as opposed to paperwork.

Validation can be a difficult and confusing process. For assistance with your validation activities, Contact Us today!