Validation Center™

Example letter requesting FDA documents available due to Freedom of Information.

The Airlie Software Council's booklet of software testing basic concepts and implementation techniques.

October, 2004 Society of Quality Assurance response to the FDA regarding the petition to revoke 21 CFR Part 11.

The Airlie Software Council's booklet of software testing principles and best practices.

September, 2004 citizen petition to the FDA from an Industry Coalition to revoke 21 CFR Part 11.

This Standard Operating Procedure (SOP) addresses the FDA requirement that computer systems be validated in a consistent and rigorous manner to ensure quality, reliability, and conformance with regulatory requirements. 

This SOP applies to computerized systems where one or more of the following conditions are met:

This Standard Operating Procedure (SOP) establishes the development life-cycle that is used to guide design, procurement, configuration or customization, maintenance, and retirement of commercial off-the-self (COTS) software systems.  This SOP applies to all computer software applications that are purchased and enable the business’ functions irrespective of FDA validation requirements.  As used in this

SOP to define the steps and controls needed to recover the Information Technology infrastructure in the event of a system failure or disaster.

This Standard Operating Procedure (SOP) establishes the development life-cycle that is used to guide design, development, maintenance, and retirement of custom developed software systems.

SOP to define the steps and controls needed to back up the Information Technology software and data for use in system restoration or recovery.   Topics include risk assessment and control, backup schedules, backup content, backup review, storage locations, and verification logs.