The European Union (EU) recently revised Annex 11 of its "Volume 4: Good Manufacturing Practice" for human and veterinary medicines to address problems stemming from an increasingly computerized GMP environment, in which computer programming can potentially replace human judgment. Annex 11 provides guidance to help ensure electronic record integrity, which in turn helps ensure product safety.
While Annex 11 is not a regulation, it is key to compliance with GMP principles in EU directives (regulations) covering human and veterinary medicinal products. Ignoring EU Annex 11 could be as detrimental as ignoring the directives.
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The revised EU Annex 11 covers a broad area that includes electronic signatures and archiving, emphasizes risk management, and expounds more on validation and security. MasterControl was designed to comply with the most rigorous regulations and standards, including EU Annex 11. Here is how it can help life science companies with their compliance efforts in the European Market:
Obtaining marketing authorization for a new medicine or medical device is a costly and arduous process, but doubly so in Europe, where there are multiple regulatory bodies. Pharmaceutical and medical device companies are likely to have simultaneous marketing authorization applications (MAA) with various agencies.
MasterControl can help companies accelerate compliance by streamlining and connecting all processes critical to their MAA documentation. Apart from complying with EU Annex 11, MasterControl offers these additional benefits:
For more information on MasterControl and how it can help with EU Annex 11 computerized software systems, please contact a MasterControl representative.