Data IntegrityPROTECTING DATA. PRESERVING TRUST.

Protect Data

With the rise of electronic and hybrid systems, data vulnerabilities are increasing. Incomplete records, audit trail failures, and data security gaps are among the most cited issues in FDA warning letters.

2024 TOP FDA 483 OBSERVATIONS

Lack of Adequate Procedures (SOPs)

Data Integrity Issues

Failure to Investigate Deviations

Environmental Monitoring Deficiencies

Poor Documentation Practices

Supplier Qualification Gaps

Inadequate Training Programs

CAPA Not Effectively Implemented

Product Release Without QA Review

Incomplete Batch Records

Our SolutionsEND-TO-END DATA INTEGRITY SERVICES

Ensure your data is complete, secure, and inspection-ready. Our experts provide end-to-end assessments, remediation, and governance strategies aligned with regulatory expectations.

Assessments

Remediation

Governance

CSA Acceleration

“CG’s support in aligning our systems with industry regulations has transformed our compliance practices. Thanks to their guidance, we are confidently embracing compliance challenges with necessary skillsets for ensuring success.”

– CIO, Pharmaceutical Company

Need Answers?KEY QUESTIONS WE HELP YOU SOLVE

How do you document and
review audit trails?

What qualifies as
backup verification?

What governance model fits
your size and complexity?

Our Integrity

Compliance Group co-authored the CSA Appendix in the ISPE GAMP Data Integrity by Design guide. We apply CSA principles to simplify and strengthen your DI program.