FDA Validation Testing


Title 21 CFR Part 11 is the section of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations for electronic records and electronic signatures (ERES). This defines the criteria by which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records.

If this puts you to sleep, it’s time to wake up and smell the regulatory coffee! You may be fine with pen, paper, and filing cabinet, but the world is going “e” and the FDA has generously provided guidelines by which life sciences companies can keep their businesses flowing along the wires without running afoul of Uncle Sam. You’re probably going to need some help with that, and Pyramid is here for you!


Today, with increasing regulatory scrutiny and requirements to comply with FDA regulations, more and more companies are seeking solutions to compliance requirements. But the FDA’s regulations for validation and testing present their own unique challenges. Pyramid can help.

Pyramid Validation And Testing Strategy

Pyramid follows FDA-certified General Principles of Software Validation and Guidance. The following diagram shows the Pyramid Validation model.

Design Qualification

Design review is a primary tool for managing and evaluating development projects. Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet the user requirements specification (URS), and to identify gaps and problems.

Installation Qualification

The scope of the IQ testing/inspections will verify that all components related to the installation are installed and work as specified, and that all required components and documentation needed for continued operation are installed and in place.

Operational Qualification

Operational qualification ensures that all aspects of the operational solution, including processes, procedures and all equipment included in the overall solution are operating correctly.

Performance Qualification

Performance qualification is implemented after successful completion of IQ and OQ steps. Testing is targeted at verifying that the performance specified in the user requirement specification (URS) is being delivered.

Component Qualification

Component qualification refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels, or even phase change material.

Why Pyramid?

Pyramid’s unique strengths set us apart:

  • We have the experience and knowledge to achieve Part 11 compliance.
  • We are experienced in applying GAMP methodology across the life cycle for computer systems validation.
    Our expertise includes pharmaceutical and biologics manufacturing, medical device manufacturing, clinical research organizations, and GLP laboratories.
  • Our jump start kits maximize your return on investment.