We provide Computer System Validation (CSV) to insure compliance to FDA Validation guidelines.
FDA Validation Overview
In order to successfully validate a software application, a validation process must be started at the beginning of a project. All phases of the project must be documented and the party(s) responsible for each of the function areas, QA, Development, Project Management, Data Base, etc. must have their documentation complete and all requisite signatures must be obtained. A validated system is one that, prior to going into production, has all of the project documentation complete, up to date, signed and in compliance with FDA guidelines. A library of the project documentation must be kept and it should be organized logically and in an easily accessible manner.
Quality Assurance plays a critical role in FDA validation. QA must establish a testing process and ensure all testing documentation (test plan, test cases, defects, etc.) is signed and dated. The FDA validation auditors usually keep the validation library for the project and review all project documentation to ensure FDA regulatory compliance and compliance with 21 CFR Part 11. For larger projects, a team of CSV auditors is required to ensure the entire project is FDA compliant.
MGD Services has many years of experience working on Computer System Validation (CSV) projects as part of the QA development process for the pharmaceutical industry. These projects require compliance to FDA Validation guidelines for computer systems used in FDA submissions. To this end, we supply CSV Auditors to ensure FDA compliance. We work closely with all project participants to ensure the entire project is in complete compliance, including 21 CFR Part 11 (see http://www.21cfrpart11.com/ for more information on Part 11). Additionally, MGD Services can provide Pharmaceutical Quality Control personnel to oversee and ensure Manufacturing Quality Assurance. See our presentation on FDA validation and compliance below.