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 QA and manufacturing activities. 

  • That the human-user has the ability to identify and detect invalid or altered records.
  • The application of human performance technology applicable to the detection, correction and prevention of intentional or inadvertently modification of data.
  • Record integrity and trustworthiness when information-objects are shared between multiple computing environments during normal business workflow.
  • That manufacturing applications are robustly designed, scientifically specified, validated, implemented, operated, maintained, and upgraded/replaced in accordance with documented GMPs throughout product’s lifecycle.
  • That data and records are contemporaneous and consistent, with all elements of the record, such as the sequence of events, being dated and/or time stamped in the expected sequence.
  • That sequence checks can be configured to direct process and workflow activities. Application environments can be configured to execute a work process while interacting with human operators, either in the direct control of equipment or ensuring that manual operations are performed in the correct order.
  • That the original record is complete with all data present and available.
  • That data and records be accurate, and with no errors or editing without documented amendments. 

You may also be interested in GCGI's Data Integrity Program in Laboratory Operations

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

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

  • That error logs and audit trails associated with a record provide the users/managers/auditors with a history of operations and transactions affecting record content, structure, and context.
  • That all record-manipulation activities be recorded in order to result in a higher degree of record integrity and trustworthiness.
  • That the historical account provided by the error log and audit trail can be configured to reconstruct preceding events and demonstrate the continuing integrity of the application’s environment.
  • Adequate enhancements to data-integrity based on the implementation of technological controls over procedural control, i.e., replacing data-entry and collection systems with robust and trustworthy validated electronic applications.
  • That record integrity and trustworthiness is maintained when the chain of custody moves from one system to another, and that they are robustly designed, scientifically specified, validated, implemented, operated, maintained, and upgraded/replaced in accordance with documented GMPs throughout product’s lifecycle.
  • Traceability for process workflows including data which must be stored securely and available on demand (if requested by auditors). 

FDA Data Integrity in Quality Assurance & Manufacturing Operations

Data Integrity

Allows personnel execute crystal-clear, accurate GMP controls to manufacturing and associated quality control activities.

The program detects and corrects actions to questionable data preventing the possibility of a company losing its license to manufacture and distribute products or the dreaded prospect of product-recall, if still valid with poor quality records!


​“Established since 1999”




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