Data Acquisition and Retention System Qualification
The capture, storage and retrieval of operating conditions for process equipment and controlled environments is a critical compliance element in pharmaceutical and biotech industries. With the evolution of computer technology, legacy paper-based systems are increasingly being replaced with electronic software-based systems which require minimal maintenance while also providing much greater fault tolerance and capabilities.
It is important to note that computer software-based systems that manage electronic data in cGMP applications must be validated per United States Food and Drug Administration 21 CFR part 820 subpart G and 21 CFR part 11 subpart B, and EU EudraLex Volume 4 Annex 11.
While there are numerous advantages of electronic data management over manual legacy systems, the validation approach and additional regulatory considerations can introduce unexpected challenges. Masy BioServices can support the integration of your new or upgraded data acquisition and retention system by evaluating your specific requirements and risk elements and implementing a robust and compliant validation strategy.
Contact Masy BioServices today for your data acquisition and retention system qualification needs.