The Importance of Validation & Compliance

Your business requires compliance and validation. But what does validation mean? At its simplest, validation is a method used to regulate electronic records and signatures. So how did this all begin, and what significance does validation hold today?

As technology advanced during the early 1990s, it became clear that organization and company paper records and signatures might need to be supplemented or replaced by electronic records and signatures. The Food and Drug Administration (FDA) therefore began a series of steps to initiate rules to address implementation of good business practices for electronic records, starting in 1991. By 2007, the final FDA guidance for such rules was published.

CFR 21 Part 11

The FDA set forth a series of guidelines for electronic records and electronic signatures, one of which is called CFR 21 Part 11. Its full name is part 11 of Title 21 of the Code of Federal Regulations (CFR); Electronic Records; Electronic Signatures. It applies to electronic records and signatures that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements in the FDA regulations. It also applies to records covered by the Public Health Service Act. CFR 21 Part 11 arose from the good manufacturing practice qualifications for pharmaceutical, medical device, and life sciences industries.

It is essential for such companies to maintain any validation, audit trails, record retention, and record copying in accordance with these FDA regulations. Computerized systems must be validated to ensure they are accurate, reliable, available, and authentic.

Qualer’s CRF 21 Part 11 Validation Service: How Our Platform Stands Apart

Qualer not only addressed the requirements of CFR 21 Part 11, is has also set forth a series of validation and compliance plans that reduce time and increase efficiency for validating applications. Qualer’s validation is executed in accordance with GxP standards, and maintains a validation library.

To validate systems in accordance with GMP standards, Qualer’s validation service protocol incorporates several documents. These protocols include a Validation and Compliance Plan (VCP), System Design Specifications (SDS), Functional Requirement Specification (FRS), Installation and Operations Qualification (IOQ) protocol, Validation Summary Report (VSR), Validation Deviation Report (DSR), and Validation Traceability Report/Traceability Matrix (TX).

Learn more about Qualer’s comprehensive Validation and Compliance Plan at https://qualer.com/qualer-validation-and-compliance-plan/.