Validation Plan Template
The Process Flow
Validation Master Plan – Your company policy on Validation approach
User Requirements Specification – Specify your needs
Validation Plan – Document your Validation Method and specific plan here
FAT – Factory Acceptance Testing (Test all requirements at supplier site
Installation Qualification (IQ) Document your installation requirements
Operational Qualification (OQ) Document all Operational/Functionality Checks
Performance Qualification (PQ) Document Performance consistency
Summary Report Summarise all your validation findings
What is Validation? Validation is to license equipment, a system or process to function against a predetermined outcome which has been established through prior studies of materials, product or the process itself. The Validation procedure begins as a project and then becomes a living state until the equipment, process or system is decommissioned or is no longer required. Validation is a legal requirement under the European and US law governed by regulatory bodies – MHRA for the European market and the FDA for the US market. Validations began heavily in the pharmaceutical industry and were later adopted by the Medical Device industry under legal requirements from the FDA and MHRA. It is now becoming a practise in the Automotive and Electronics industry.
Your Standard Operating Procedures – SOPs As part of your manufacturing procedure you must have Standard Operating Procedures to ensure that all stages of the process of manufacture is standardised under a controlled document that is easy to follow which can be assisted with aid of visual diagrams or photos. The SOP must also be written in the language that is understood and be clear and unambiguous. The SOP must follow Good Documentation Practise.
Your Master Validation Schedule – controlling your programme Your Validations need to be outlined in a clear timeline with dates for completion with responsibilities. This must be a living document with dates for revalidation once the original validation has been completed. The revalidation frequency can be determined on risk and criticality of process. A frequency of yearly or every two years is common. At the intervals the equipment/process/system will typically be review for any change or any issues raised during the interval, and an assessment will be made if any revalidation activity needs to take place or if this can be justified with a rationale.
Your Validation approach – Validation Master Plan/Policy Your site wide document and take on validations should be clearly outlined in a high level document which is your Validation Master Plan or Policy which indicates your approach to validation from software systems to lab, cleaning, equipment etc. Responsibilities and your revalidation programme should also be listed here. A statistical programme must also be clearly outlined here.