Leading biotechnology company

• Medicine manufacturing systems must work perfectly to ensure product safety and quality.
• Auditors demand a clear history of all tests completed.

Developing and manufacturing life-preserving medicines demands high-level production expertise combined with an unwavering focus on quality and safety. Defects and errors could lead to significant harm, and companies must adhere to strict regulations in all of the countries in which they operate.

This leading biotechnology company must assess each of the systems and processes powering its business activities. And for those systems directly or indirectly impacting patient safety, more stringent validation is required by regulations such as US FDA 21 CFR. A spokesperson comments: “We really do evaluate every single one of our systems down to the finest detail—from the software supporting our back-office activities all the way through every production system and the final packaging machines.”

With a presence in more than 100 countries, managing and monitoring testing is a complex operation, with regulatory standards varying in different jurisdictions. The company must not only conduct tests in line with regulatory standards, but also keep a detailed record of its testing activities to maintain full compliance.

To achieve this, a dedicated team conducts Computer Systems Validation (CSV) activities regularly to test, validate and document all the systems used by the company. At the start of the CSV assessment, the company determines which of the Good Automated Manufacturing Practices (GAMP 5) categories each system fits into, based on guidelines from the International Society for Pharmaceutical Engineering.

Once a GAMP 5 category is established, testers then begin the validation process to ensure that the system in question is fit for the intended use and meets the relevant regulatory requirements. This includes adherence to industry-standard ALCOA+ principles, which target data integrity with the goal of ensuring that the entire system is Attributable, Legible, Contemporaneous, Original, Accurate, plus complete, consistent and enduring throughout its lifecycle.

With hundreds of computer-based systems across its sites, managing testing cycles can be exceptionally time-consuming – not least because around 3,500 users are involved. The company found that its existing processes such as manually handling evidence and a physical signature process made managing and monitoring testing activities complex and cumbersome.