Challenge
This global leader in medical technology and services needed to ensure that its validation procedures and systems complied with the FDA Quality System Regulation (21CFR Part 820), and FDA electronic records and signatures regulation 21 CFR Part 11.

Solution
Performed FDA validation assessment of select systems and recommended a strategy for on-going compliance programs to maintain market leadership.

Benefits
The strategy assessment produced key items for a regulatory action plan, including:

• Developing a validation training program
• Establishing formal Standard Operating Procedures (SOPs) for validation determination, computer systems validation and system development lifecycle
• Developing a 21 CFR Part 11 compliance plan

Download full PDF