One of the most common failures cited by FDA inspectors in Warning Letters is the…
10/18/2018 Cary, NC – Adopters of electronic software solutions are required to complete various computer system validations outlined in the FDA’s Quality System Regulations (QSR), 21 CFR 820.75, and in the General Principles of Software Validation; Final Version for Industry and FDA Staff.
Thus, InstantGMP, Inc., creator of the InstantGMP™ suite of software created test scripts in the latest 3.009.001 updates and releases of the software to both expedite the validation of new versions and to lessen the resource-intensive burden for required for manufacturing of products under Code of Federal Regulations (CFR) Part 211 for Pharmaceuticals.
Computer System Validation can be broken down into two major parts: Software Development Life Cycle (SDLC) steps and the Computer Validation steps. The SDLC steps oversee the development of user requirement specifications; functional specifications, and detailed design specifications. Once developed, the code is subjected to unit test and factory acceptance testing before it can be released.
The Computer Validation steps started after the finished SDLC steps and include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). To make their validation more thorough, InstantGMP, Inc. implemented a streamlined, automated OQ process validation tool for compliance with the FDA’s pharmaceutical, biopharmaceutical, biologics, and biotech manufacturers and distributors validation rules.
The FDA considers software validation to be “confirmation by examination and provision of the objective evidence that software specifications conform to their needs and intended uses, and that the particular requirements developed through software can be consistently fulfilled.”
The scope of validation is outlined in a Validation Master Plan to ensure that any process affecting the efficacy, quality, and batch documentation is qualified, as reproducibility is the core philosophy of the FDA’s regulations.
The automated OQ validation tests, created by qualified experts, is consistent with the rules of Part 820.75(b)(1) and internally checks the functionality of InstantGMP™ PRO and InstantGMP™ INV software against established user requirement specifications. Once completed, the test scripts output a completed report of the OQ results compliant with Part 820.25(b)(2).
Computer validation, as well as QSR, are components of Good Manufacturing Practices (GMPs) compliance and must be maintained on an ongoing basis. With each new update and release, the automated validation must be completed before deployment and is available an optional addition to licenses of InstantGMP™ PRO for bioprocessing or InstantGMP™ INV for inventory management. Both InstantGMP™ PRO and InstantGMP™ INV assist companies with improved batch and quality management, as well as increased compliance with CFR Part 211.
About InstantGMP, Inc.
InstantGMP, Inc. is the creator behind the InstantGMP™ software that organizes and manages manufacturing processes with the goal of improving batch quality and consistency across several different industry verticals; including biopharmaceuticals, biotech, cannabis, CBD & hemp, cosmetics, dietary supplements, e-liquids, and medical devices. The software is the brain-child of Dr. Richard Soltero, a pharmaceutical veteran, and quality extraordinaire. InstantGMP, Inc.’s focus is developing software for products that are regulated by the FDA.