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.
- 1 week ago
FDA Regulatory and Compliance News FDA ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health...
- 2 weeks ago
FDA Regulatory and Compliance News FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously, 21-0, that the benefits and risks of...
- 1 month ago
ANN ARBOR, Mich. and ARLINGTON, Va. – NSF Health Sciences Certification, LLC (NSF), which provides testing, auditing, certification and training...
- Monday, November 30, 2015
- 8:30am - 4:00pm GMT
- Manchester, United Kingdom
- Thursday, December 3, 2015
- 11:00am - 12:00pm Eastern Time
- Webinar, District of Columbia, United States
- Monday, December 7, 2015
- 1:00pm - 2:00pm GMT
- Webinar, United Kingdom
- Monday, January 18, 2016
- 8:30am - 3:00pm GMT
- York, United Kingdom