Once again Zener Engineering Services (ZES) Ltd representatives are asked to support the fight against the Coronavirus. On this occasion ZES undertook a Data Integrity Audit for a Coronavirus treatment research and manufacturing centre.

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 sound rationale.

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

Zener Engineering Services (ZES) Ltd representatives performed Data Integrity audits against the latest Regulatory Requirements and guidance. If Data Integrity weaknesses are identified, ZES can 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 subject matters such as:

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

A busy time for ZES Director David Easton as he personally helps in the fight against the Coronavirus.

David explains ‘We’ve been asked to perform a Data Integrity Audit across an Organisation's manufacturing operation. The site is gearing up to develop and manufacture a Coronavirus vaccine and / or treatments.’

David continues ‘We found a number of issues and submitted a report, suggesting a number of improvements. The audit was performed against MHRA regulatory requirements and guidelines, whilst focusing on Data Integrity requirements for manufacturing and laboratory equipment.

The audit went very well over the course of a 3-day period, with myself and the Organisation's representatives working very well together. I would like to thank the organisations team who were very accommodating and open minded during the audit. ZES hope to further engage with the Organisation to remediate the audit findings in due course.'

Adherence to Data Integrity Regulatory Requirements is key to providing a safe treatment or vaccine against the Coronavirus. Throughout the course of any audit performed by ZES, the ZES auditor will utilised their many years of practical experience to identify areas for improvements and establish a strategy to mitigate any perceived shortcomings and risk.

The ZES auditor can spend a number of days reviewing an Organisation's current provision and practices for safeguarding electronic Data Integrity against Industry Best Practice, focusing in particular on areas such as:

• User Accounts, User Access and Administrator Roles
• Electronic Signatures, Records, Audit Trail
• ALCOA+, Raw Data, Meta Data
• Review and Approvals
• Data Governance

The Audit Report from Zener Engineering Services Ltd will detail areas of concern and opportunities for improvement.

Data Integrity is defined in the MHRA guidance as:

‘Data integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.’

Need a Data Integrity Audit Performed by an Industry Expert?

If you would like to find out more about our Audit Services or Computer System Validation Services (CSV) or Data Integrity ,

then please Contact ZES.

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