In an effort to enhance consistent quality, address data integrity challenges, reduce costs, and minimize risk, Life Science companies are seeking to optimize their Validation processes. In doing so they naturally consider going paperless and typically look at an existing IT system, before considering a built for purpose paperless validation solution.
Data Integrity is a major concern for the global pharmaceutical and medical device industries, across many of their business areas. Global regulatory authorities have increased their inspection focus to ensure good Data Integrity practices are being implemented. The increased focus results from inspection observations of significant deficiencies.
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Process validation is a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals (21CFR 211) and of the GMP regulations for medical devices (21 CFR 820) and therefore applies to the manufacture of both drug products and medical devices.
It’s a question commonly asked in the validation arena, what is the difference between a FAT and a SAT. This article will finally explain what the difference is and why each one is required.
Any project that involves equipment being developed from a third party should have a FAT and SAT incorporated into the system life-cycle. If both the FAT and SAT are performed correctly is will lead to a much easier IQ/OQ process.
What is a FAT