Data Integrity Is Currently A Regulatory Hot Topic!

Are Your Electronic Records
And Electronic Signatures Secure?

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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.

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Data Integrity Audits Performed By ZES

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:

• ALCOA+
• Data Life Cycle
• Company Culture
• Data Governance
• Data Organisation
• Regulatory Updates
• System and Process Design
• Data Integrity Supporting Processes
• Data Criticality and Inherent Integrity Risk

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Testimonial

Pharmaceutical Manufacturing: DCS CSV

"I worked with David [of Zener Engineering Services] on a project to deliver an ABB 800XA DCS system for a Blue Chip Pharmaceutical company. He was the QA lead for the supplier.

We jointly reviewed and approved a very large FAT document set in lieu of a reduced SAT and OQ. David's approach is very professional, critical, but crucially pragmatic.

I enjoyed working with him and would welcome any future opportunities to do so."

Steve Del-Bianco
Computer Systems Validation Analyst
GlaxoSmithKline GMS WARE

Guidance for the UK.

The GxP Data Integrity guidance has a high degree of alignment with documents published by other regulators such as PIC/S, WHO, OECD (guidance and advisory documents on GLP) and EMA. It is designed to facilitate compliance through education, whilst clarifying the MHRA’s position on data integrity and the minimum expectation to achieve compliance.