DEACOM’s software development model allows it to act as a “Commercial off the Shelf” (COTS) software, simplifying the 21 CFR Part 11 validation process during implementation.
DEACOM ERP software provides many tools to assist with the process which includes recording the history of all data conversion loads completed during implementation, outlining base test scripts that can be configured to support the OQ process, and providing Standard Operating Procedure (SOP) functionality to make creating the documents easier.
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.
The table below outlines Deacom’s typical deliverable schedule for each of the primary areas of the validation process.
The schedule may be tailored for individual companies as necessary.
The FDA requires a specific set of documents as part of the 21 CFR Part 11 validation process and they are listed below.