Validating pharmaceutical systems

The list itself should be organized by Gx P (GCP, GLP or GMP) so you can sort the list accordingly during an inspection or for analysis purposes.

Next, the list should include a system owner for each system so you know who is responsible for the system and who to call upon during an inspection.

Often times, the FDA comes to inspect your facility for reasons other than your CSV program.

This white paper uses that FDA guidance as an input to define an “easy-to-implement” framework for systems validation.

Finally, the paper identifies a best practice, which calls for IT organizations and software vendors to proactively audit their software development and implementation processes on an ongoing basis to identify and correct any systemic issues to lower the cost of compliance. Current Good Manufacturing Practices (c GMP) are mandated by the FDA to ensure that the products manufactured by the industries such as pharmaceutical, biotech and medical devices, meet specific requirements for identity, strength, quality, and purity.

In order to comply with c GMP, companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs), Master Production Batch Record (MPBR), Production Batch Record (PBR), Equipment log books etc.

Traditional computer system validation is an inefficient and time consuming paper based process that is plagued with a significant amount of inefficiencies.

Paper-based computer system validation requires that highly skilled technical resources dedicate approximately 50% of their time on non-value added activities which include the following inefficiencies: Traditional computer system validation requires resources to dedicate a significant amount of effort to create and maintain traceability matrixes during the lifecycle.

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