Data Integrity Auditing & CSV

Compliance with cGMP requires companies record, track, manage, store, and easily access documents such as Standard Operating Procedures (SOPs), Batch Records, Test Data, and log books. Current regulations also require manufacturers to review Electronic Batch Records (EBRs) of manufactured batches and resolve all discrepancies prior to batch release. EBRs consisting of electronic records should be reliable, trustworthy, traceable, and verifiable to conform with US FDA’s 21 Code of Federal Regulations (CFR) Part 11 and European Union’s Annex 11.

Contact us »

How we can help

Our data integrity, validation, and quality experts perform comprehensive computer systems and data assessments to ensure your system requirements are fully met and adequately documented.

Data governance and management practices are evaluated using risk-based validation strategies to protect the integrity of your data and strengthen your quality system in the process. Compliance gaps identified during the assessment are addressed through comprehensive remediation.

Thorough computer system validation (CSV) ensures your system stands up to scrutiny, leaving you secure in the knowledge that your data is safe, reliable, and available. Our CSV experts implement systems and obtain “fit for use” certification in the areas of computer and cloud systems validation and data integrity.

Our framework for CSV and data integrity assessment can be applied to both proprietary and commercially available software. Projects are planned and executed by leading computer system validation experts with intimate knowledge of current regulatory requirements and years of experience enhancing IT operations, control systems, and data integrity for pharmaceutical, medical device, and biotechnology companies.

Our comprehensive data integrity and computer systems validation services include, but are not limited to: 

  • Computerized and Cloud System Validation (CCSV) and qualification
  • Establishing data integrity infrastructures
  • Third party CMO audits
  • Vendor audits
  • Mock Pre-Approval Inspection (PAI) audits of data integrity
  • Formal risk assessments and risk mitigation strategies

Additionally, we assist clients in: 

  • Planning and remediation assistance for data integrity gaps
  • Guidance and development of Data Governance and Data Management Programs
  • FDA-483 and warning letter responses for data integrity
  • Pre-audit preparation and support during audits
  • Training and development of training programs in data integrity and CSV


Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.

Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf. 

Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.

Contact us »

Why work with The FDA Group?

  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

Read our brochure »

Contact us today to learn more about our data integrity auditing and CSV services.