The traditional validation approach is typically very inefficient due to several issues that impact cycle time, cost, quality and the intent of the process.
One of the areas that have a direct impact on efficiency is the reliance on traditional protocols for all validation activities.
Traditional protocols require resources to manage the entire document lifecycle that includes activities such as the creation, review, and approval of validation protocols.
These activities also require additional activities such as managing, consolidating comments, and negotiating with key stakeholder to complete the lifecycle with a final document approval.
These traditional activities such as relying on protocols for all validation activities are not efficient, cost effective, and are not a reliable tool to ensure the quality of the process and compliance with regulatory requirements.
This article will also discuss alternatives to the traditional validation approach of relying on validation protocols for all validation activities.