Protect the integrity of your data and ensure your systems stand up to regulatory scrutiny.

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.

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

Contact The FDA Group today for a Data Integrity & Computer System Validation consultation.