FDA Part 11, Pre-Approval Inspections and Clinical Data Integrity
Getting ready to submit a new medicine or product for FDA approval is a hectic, anxious time. Worry that FDA will raise questions about data integrity and Part 11 only adds to the stress. Amid it all, day-to-day business must go on. And let’s not forget organizational dynamics, cross-functional challenges and tightened budgets.
Here’s what one senior manager of clinical compliance had to say about Cerulean’s help during this stressful time:
“John’s approach to Part 11 compliance was skillful in emphasizing how pharma and biotech companies can balance bottom lines to align with FDA expectations. He demystified the technical concepts of Part 11 and translated them into real-world best practices to help us manage patients’ safety, rights, and data integrity.”
– Mai Nguyen, Senior Manager, R&D Quality and Compliance, Boston, Massachusetts
If you’re looking for a trustworthy, common-sense Part 11 consultant or an electronic data integrity expert, take a look at our specialized Part 11 compliance consulting services or download and read some of our 21 CFR 11 “how to” articles. And then contact us when you’re ready to streamline, simplify and strengthen FDA Part 11 compliance.