More from Dr Zuhdi Hussein
The CAPA process from the side of regulatory compliance of both U.S. FDA requirements (21 CFR 820.100) and EU regulatory requirements (ISO 13485, 8.5.2) is one of the most important elements of a Quality Management System (QMS).
It is essential to develop a system the right way to assure QMS effectiveness and minimize irregular findings on regulatory audits.
Improve Manufacturing with CPPs
Data integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of the conformity backlash. There continues to be heightened regulatory focus on diverse cybersecurity topics, including data integrity.
Pharmaceutical firms that wish to create product lines and cater to consumers as reliably as possible must ensure that their products are of a consistently high enough quality to fulfill user needs. While certain post-production checks and assurances can aid in this area, many organizations find it far more helpful to institute quality by design standards (QbD).
When GxP firms take actions to maintain compliance with recommendations from the FDA and the EU, it's critical that they actually analyze the results after the fact. Failing to assess your compliance implementations effectively and on a periodic basis could result in a regulatory authority taking action against your company.
Medical device manufacturers and pharmaceutical companies use advanced IT tools to maintain sensitive business information, manufacture products and establish valid Quality Systems. In the past data integrity has been an important topic and is an increasingly important focus for FDA and EU regulators. The architectures employed by life sciences firms must be designed to facilitate consistent oversight and well-maintained compliance.