This document describes the Validation Master Plan employed at <company>, including the mechanism used to manage validation activities and the documentation prepared to support the validation effort.
This SOP defines the System Development Life Cycle (SDLC) methodology to be utilized during the validation of a computer system, including the development, use, maintenance, and retirement of the system for Food and Drug Administration (FDA) regulated business activities at <company>. The SDLC adopted at <company> will be referred to in this document as the methodology used for the Validation Master Plan.
This corporate Standard Operating Procedure (SOP) applies to <company>. This SOP does not supersede any procedures supporting similar computer validation initiatives at the site or local level.
This SOP applies to all vendor-purchased, in-house developed, local, and enterprise computer systems applicable under FDA regulations, that are used to create, modify, maintain, archive, retrieve, or transmit electronic records governed by the requirements set forth by the FDA. Such computer systems are required to be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
Validation documentation produced from the SDLC is required to be part of FDA regulated, IS projects. However, the details associated with each deliverable will be dependent upon individual department or site SOPs and the complexity of the computer system being evaluated. This SOP identifies the minimum requirements for each validation deliverable described for validated systems. Refer to Section 8 for the typical deliverables in each phase of the SDLC.
Download the associated presentation, "Developing a Validation Master Plan that Survives the Life Cycle," from IVT's 16th Annual Validation Week, Philadelphia, PA, 2010.