Data Integrity Audits
- Why Work With NSF?
Data integrity has come under increasing focus by many of the world’s regulatory agencies, and many companies are struggling with data integrity issues. NSF Pharma Biotech experts have conducted numerous data integrity reviews and audits, identifying data integrity issues and providing remediation solutions to systems and practices needing correction. We have helped companies lift import restrictions associated with data integrity observations and have assisted companies with data integrity reviews under the FDA’s Application Integrity Policy (AIP).
Our audits review all aspects of your records and data recording practices including laboratory systems and electronic storage. We also verify the accuracy and reliability of data submitted in drug and biologic marketing authorization applications.
Why Work With NSF?
Our data integrity audits, and the resulting remediation plans, are trusted by pharmaceutical and biotech companies – and regulatory agencies – all over the world. Our unique blend of former regulatory agency inspectors and industry professionals ensures that you receive a thorough audit with no stone left unturned and sound, pragmatic recommendations for improvements and remediation.
- 4 months ago
FDA Regulatory and Compliance News FDA announced the availability of a draft guidance for industry and FDA staff entitled, “Public...
- 4 months ago
FDA Regulatory and Compliance News FDA announced the approval of Torax Medical’s Fenix Continence Restoration System to treat fecal incontinence...
- 6 months ago
ANN ARBOR, Mich. and ARLINGTON, Va. – NSF Health Sciences Certification, LLC (NSF), which provides testing, auditing, certification and training...
- Wednesday, April 20, 2016
- 8:30am - 12:00pm Pacific Time
- San Diego, California, United States
- Thursday, May 5, 2016
- 1:00pm - 1:30pm GMT
- Webinar, United Kingdom
- Monday, May 9, 2016
- 8:30am - 3:00pm GMT
- Glasgow, United Kingdom
- Monday, May 16, 2016
- 8:30am - 5:00pm GMT
- Manchester, United Kingdom