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REGULATORY COMPLIANCE SERVICES

  • A Data Integrity Gap Assessment Worksheet Template.
  • Step-by-step procedure on how to document data integrity gaps during the evaluation of laboratory data. 
  • Document risk assessment and impact to product quality.
  • Determine company's quality level in cGMP compliance.

The Food and Drug Administration (FDA) has increased its attention on data integrity and taken regulatory and enforcement actions against regulated companies. The Agency's mission in consumer protection is being impacted since the information it receives from regulated companies in some cases is not trustworthy.  The accuracy, reliability, and general trustworthiness of data is a broad concept and applicable to areas other than computer system validation (CSV) and electronic records/electronic signatures (21 CFR Part 11). 


​GCGI’s Data Integrity support services are systems-oriented. Within this system, there are three (3) subsystems that can be thought of as gears: Validated State, Human Performance Technology (HPT) and Requirements Traceability. 

Contact Johnny Guerra, former FDA Computer Specialist & FDA Supervisory Chemist, to support your Laboratory Data Integrity activities.

Data Integrity

  • A data integrity approach to input/output laboratory process.
  • Learn data integrity content and structure.
  • Learn how to document circumstances under which records were created.
  • Analytical Method Validation.
  • SOPs, Sample Management & Laboratory Records. 
  • Equipment, Instruments & Computers. 
  • Chromatographic Data Systems. 
  • Microbiology Laboratory Operations.

FDA Data Integrity in Laboratory Operations

Training Aids

You may also be interested in GCGI's Data Integrity Program - QA & Manufacturing Operations


  • Learn how to execute a Data Integrity Traceability Action Plan related to Laboratory Operations.
  • Learn FDA’s Data Integrity expectations on:
  • ​Learn how to document extreme laboratory GMP issues.

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Energizing these gears are four catalysts:


  1. Strategies: Design and planning activities for regulatory compliance.
  2. Assessment: Measures of Effectiveness (MOE) on data integrity efforts.
  3. Data: Used to quantify progress and deficiency to develop necessary corrective and preventive action plans.
  4. Knowledge Transfer: To both share and homogenize the entire data integrity effort among firm’s corporation, suppliers and sites.

These gears and catalysts provide firms with an outcomes-based, data-driven, top-down GMP system that supports regulatory requirements. Experience has shown that by making regulations work to firms’ advantage, many companies have increased productivity and improved product quality while decreasing expensive rework.


GCGI’s Consulting, Auditing and Training services provides the required knowledge to put into action the four catalysts. Understanding how these subsystems work together allows firms to fully integrate data integrity principles into daily GMP laboratory activities.