Performance Validation has assisted domestic and international Medical Device manufacturers in meeting the US FDA and ISO 13485 requirements. PV has assisted several large (Fortune 500) companies, foreign subsidiaries, and smaller medical device companies in the review, audit, and enhancement of their Quality Systems.
Our team includes ASQ certified quality auditors, ISO 13485 certified auditors, and Lean Six Sigma Black Belts and Green Belts that have experience in the regulated industry.
Services provided have included development, enhancement and implementation of:
- Validation Program which provide an industry standard approach based on the concepts of GHTF, ICH, GAMP, ISPE, and ISO to meet the expectations set forth in the Quality System Regulations.
- Development of Procedures that address other QSIT elements, including management controls, design controls, corrective and preventive actions, and production and process controls.
- Auditing of client Quality Management System, and or suppliers including audits of:
- Validation program (Governing documents such as production equipment qualification, facility qualification, process validation, cleaning validation, computer system validation, analytical equipment qualification and methods qualification).
- Supplier assessments of new or current vendors.
- Completed qualification and validation packages.
- Design History File
- Change Control
- Batch Record Reviews
Programs developed on the behalf of our customers have been successfully evaluated by client internal audits, FDA inspection and ISO certification/recertification audits. These programs have allowed our clients to transition from Official Action Indicated (USFDDA) to No Action Indicated (USFDA) on subsequent inspections.