Data Integrity Remediation Consulting

When a company faces remediation, NSF offers the full range of services from gap assessments to remediation support.

Gap assessments help determine the scope of the problem and include:

• Addressing cultural root cause(s) of data integrity issues
• Applying systemic data integrity remediation, which can be incorporated as part of the overall quality management system, using practical yet compliant solutions
• Providing training and education to all levels of an organization
• Supplying specific computer system expertise for compliance with 21 CFR Part 11 and EU Annex 11 required controls

We provide remediation support for regulatory actions including:

• EU critical inspection findings
• EU statements of non-compliance
• U.S. 483s
• U.S. warning letters
• U.S. consent decrees
• U.S. Application Integrity Policy (AIP)
• U.S. import alerts (DWPE)

We can also provide a third-party data integrity expert to help you with your remediation efforts.

For more information about FDA and Health Canada related services in quality systems and compliance, email uspharma@nsf.org or call +1 202.822.1850.

For European and other international agencies, email pharmamail@nsf.org or call +44 1751 432 999.

Why Work With NSF?

Challenge: A large manufacturer in the southeastern U.S. that was under FDA consent decree regarding data integrity contacted NSF.

Solution: We served as the subject matter expert on FDA’s Application Integrity Policy (AIP), developed the FDA-approved application integrity audit plan protocol, determined the scope of issues and procedures for evaluating the company’s product evaluation, performed on-site New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) data verification, and provided ad hoc consulting on all aspects of the AIP and consent decree processes, including recommendations related to interactions with the FDA.

Benefits

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.