Data and Document Auditing

As you know, clear and consistent documents contribute to a faster approval time. Our data and document quality assurance team at Polaris is extremely detail-oriented. We can conduct quality audits on your data, reports, and documents, and make sure they are both compliant with applicable regulations and internally consistent. Then you can focus on the bigger picture.

Data and Document Auditing Here are some of the types of data and report we can audit:

Stability Protocols and Reports
Annual Product Reports
Periodic Safety Update Reports
Non-clinical Study Reports
Clinical Study Reports
Investigator Brochures
Integrated Summaries of Efficacy
Integrated Summaries of Safety
SAE narratives
Analytical data vs. source documentation
Contributions by various departments
CMC, non-clinical, and clinical sections for NDAs and ANDAs

Depending on the type of document or data you ask us to review, Polaris auditors will:

Perform internal consistency checks
- Compare text to tables, tables to appendices, appendices to listings, listings to CRFs
Evaluate compliance with applicable regulations and guidelines
Compare manufacturing, non-clinical, and clinical overview/summary sections, Investigator Brochures, and integrated clinical summaries for INDs, NDAs, ANDAs, and BLAs to the underlying records, study reports, published references, etc.
Compare clinical study reports to the protocol, CRFs, data listings, and database
Assess technical transfer for manufacturing and test methods
Review submitted method validations

We conduct compliance audits
and save time to market for
our customers worldwide.
How can we help you?

Polaris Compliance Consultants, Inc.
1151 Executive Circle Suite 202

Cary, NC 27511-4589
(919) 463-0003

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Data & Document

Data and Document Auditing