Computer system Validation

    In Earlier post we understood what is System Release Certificate (SRC) in computer system validation? Now in this article we are going to understand Checklist which useful for Computer System Validation Documents Preparation & Review. The checklist items provide a frame of reference for users and auditors to better determine potential compliance issues with computer system validation.   All items in the checklist should be checked effectiveness of CSV for individual systems, especially where those systems use different control measures. This checklist will enable you to systematically assess the strengths and weaknesses of a computer system validation using a uniform approach. This checklist can be used to evaluate potential validation contract vendors/suppliers (front cover letter included). This checklist was created in line with regulatory requirements of your computer system validation such as FDA 21 CFR Part 11 Electronic records and elec...

  In Earlier post we understood What is Validation Master Plan, Its content & Regulatory requirement in Computer system validation? Now in this article we are going to understand what is System Release Certificate (SRC) in computer system validation. System Release Certificate (SRC) is authorizes the release of System for use in the Production Environment at Location for the users in the department. The objectives of this SRC are to certify that System has been successfully validated and can be used by the users in the department at Location. It is essential because it confirms that all project/system has been completed as per regulatory standard mentioned in project plan.   This certificate provides confirmation that all activities specified in the validation plan have been completed & all acceptance criteria have been met and the software is ready for deployment. All system-related documents/procedures will be provided, developed and/or will be revised be...

  What is Validation Master Plan & Is your auditors happy to seeing validation plans? In Earlier post we understood How to Conduct a GAP Assessment in Computer System Validation process. Now in this article we are going to understand What is Validation Master Plan, Its content & Regulatory requirement in Computer system validation? What is Validation Master Plan? EU GMP Vol. 4 Annex 15 says: “The key elements of a validation program should be clearly defined and documented in a validation master plan (VMP) or equivalent documents.” Validation Master Plan helps give sense and organization to your validation efforts, and an understanding of how it supports the goals of your facility. It makes auditors happy because they are used to seeing validation plans. Top management is not always aware of the real requirements for validations and qualifications. They generally focus on finances and business processes. The Validation Master Plan helps educate management ...