Audit Trail Review – A Data Integrity Issue

Data integrity demands a great amount of attention in the life science industry. This is now truer than ever with increased focus from the FDA, EU, and industry standards on data integrity issues and best practices. Audit trails for computerized systems are required for all FDA / EU regulated systems.more


Medical Device Programming System Validation

Medical Device Programming System Validation

The service engineering department of a leading medical device manufacturer developed a fully custom medical device programming system for distribution to its global service centers.  This new programming system was a down-scaled version of a larger and more complex automated system that the client used in production for the testing and programming of electronically driven motorized surgical devices.more


Data Integrity – Audit Trail Review

Data integrity demands a great amount of attention in the life science industry. This is now truer than ever with increased focus from the FDA, EU, and industry standards on data integrity issues and best practices. Audit trails for computerized systems are required for all FDA / EU regulated systems.more


2017 Society of Quality Assurance Annual Meeting

Are you planning to attend the 2017 Society of Quality Assurance Annual Meeting March 26-31, in National Harbor, Maryland?

If YES, please plan to stop by Booth 315 to meet Kevin Marcial of the Performance Validation team.

Performance Validation is a Value Added Reseller of the Adaptive GRC solution. … more


Governance, Risk, and Compliance (GRC) Basic Concepts

Governance, risk, and compliance or GRC is a term one in the pharma or biotech world might not hear all that often. It is a concept most often employed in financial, legal, and information technology divisions. “Governance” refers to the processes/procedures/activities used to manage the organization – such as management processes.… more


Testing and Risk-Based Computer System Validation

Performance Validation recently featured an introductory post on risk-based computer system validation. It is an approach by which one can focus the validation effort on critical business and regulatory requirements and reduce the need for excessive testing and redundancy. A fundamental aspect of this approach is to leverage software vendor functional testing.more


Risk Based Computer System Validation – A Primer

Risk-based computer system validation is a term widely used in our industry now, but understanding and implementing it can be challenging. Often, organizations want “cheaper, faster, better” but when the details of a risk-based computer system validation (CSV) plan are defined, they may find that their expectations have not been met.… more


Part 11 Compliance Considerations for SCADA Systems

Supervisory Control and Data Acquisition (SCADA) systems are tremendous assets in the pharmaceutical, medical device, and other FDA regulated manufacturing industries, providing cost efficiencies and improving the consistency of product quality. They have also enabled the industries to move from hardcopy to electronic production records.… more


FDA Proposed Rule for a GLP Quality System

Those of us who have worked in pharmaceuticals or medical device are familiar with the concept and requirements of a Quality System. On August 24, 2016, the FDA issued a proposed a rule to the Good Laboratory Practices (GLPs, 21 CFR part 58), titled  “Good Laboratory Practice for Nonclinical Laboratory Studies”.more