Software as a Medical Device (SaMD): Clinical Evaluation and Validation

Your doctor is probably not using the data from your wearable (e.g. fitbit) to make decisions about your health. However, this is the kind of question we begin to ask when considering Software as a Medical Device (SaMD). By definition, these are applications (software) intended for medical use without the use of hardware (International Medical Device Regulators Forum (IMDRF) guidance).more


503B Electronic Record Data Integrity

For compounding pharmacies regulated under section 503B, electronic record data integrity concerns are increasing in regulatory and customer visibility. The concepts of good data integrity practices is not new. Yet an organization can inadvertently open itself up to serious problems with their electronic record integrity if proper operating and computer system validation procedures are not followed.more


Validation of Ignition SCADA (Inductive Automation) System for Medical Device Assembly

A leading medical device manufacturer introduced a new production line to their assembly facility.  The new line was designed to accommodate the simultaneous production of several makes and models of hand-held motor-driven surgical devices.  This new line was designed to apply the latest integrated manufacturing technology to optimize flexibility, efficiency, quality controls, and real-time accountability toward meeting immediate market demand for product.  … more


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

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