Data Integrity is currently a regulatory hot topic and has been included as documented observations in a number of recent inspection reports.

For GxP applications, Data Integrity arrangements must ensure that the accuracy, completeness, content and meaning of data are retained throughout the data lifecycle.

The way in which regulatory data is generated has continued to evolve in line with the introduction and ongoing development of supporting technologies, supply chains and ways of working. Systems to support these ways of working can range from manual processes with paper records to the use of computerised systems. However, the main purpose of the regulatory requirements remains the same; having confidence in the quality and the integrity of the data generated and being able to reconstruct activities remain fundamental requirements.

Systems and processes should be designed in a way that encourages compliance with the principles of data integrity. Consideration should be given to ease of access, usability and location whilst ensuring appropriate control of the activity guided by the criticality of the data.

Regulatory Authorities require Life Science manufacturing organisations to take responsibility for the computer systems utilised during manufacturing operations and the GxP Data they generate.

Life Science manufacturing organisations are expected to implement, design and operate a documented system that provides an acceptable state of control based on a documented Data Integrity Risk Assessment supported by a sound rationale.

The organisational culture should ensure that the generated data is complete, consistent and accurate in all its forms, i.e. paper and electronic.

Zener Engineering Services Ltd (ZES) perform Data Integrity audits against the latest Regulatory Requirements and Guidance. If Data Integrity weaknesses are identified, ZES support the manufacturer to ensure that appropriate corrective and preventive actions are implemented across all relevant activities and systems.

The ZES Data Integrity Audit includes, but is not limited to, the following subject matters:

• Data Criticality and Inherent Integrity Risk
• System and Process Design
• ALCOA+

Following the submission of a 37-page Data Integrity Audit Report from ZES, the client provided feedback, part of which is quoted below:

"........ turns out that on a national level the BMS [Building Management System] has never been validated by [supplier organisation removed]. So we have opened up a can of worms for them! [Organisation removed] are arranging each centre in the country to validate it.."

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Senior management is responsible for the implementation of systems and procedures to minimise the potential risk to data integrity, and for identifying the residual risk.

Routine data reviews should evaluate the integrity of an individual data set, compliance with established organisational and technical measures and any data risk indicators.

Where GxP computerised systems are used to capture, process, report, store and archive raw data electronically, system design should always provide for the retention of audit trails to show all changes to the data while retaining previous and original data. Electronic Signatures and Records (ERES) must provide integrity.

Backup and recovery processes should be validated and periodically tested.

For information on GxP computer systems and databases

ZES have validated to ensure Data Integrity, click below: