Case Study: NAMSA (North American Science Associates) achieves rigorous FDA and ISO compliance with MasterControl

NAMSA, a Leading Contract Testing Laboratory, Relies on MasterControl in Meeting Rigorous FDA and ISO Requirements

North American Science Associates (NAMSA) is a multinational contract testing laboratory founded in 1967 that provides testing, consulting and sterility-assurance products to medical device, pharmaceutical and biotech companies. Facing strict FDA (21 CFR Parts 820 and 11) and ISO requirements, NAMSA had been managing thousands of SOPs, reports and protocols manually in Word files and folders, a slow, error-prone process that made review, approval and training inefficient and compliance more difficult.

NAMSA implemented the web‑based MasterControl quality management suite (going live on time and on budget) to centralize document control, automate forms and workflows, and validate electronic records. The system now handles ~4,000 documents, provides robust revision control, status tracking, time‑stamped audit trails and secure vaulting, improved efficiency and traceability across departments, and has helped NAMSA maintain compliance without adverse FDA findings.

NAMSA

Lisa Swartz

Document Administrator