Zener Engineering Services (ZES) representatives were asked to support the fight against the Coronavirus by conducting a Data Integrity Audit for a life sciences company.
On this occasion ZES undertook the audit at 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.
The ZES Data Integrity Audit includes subject matters such as:
- Data criticality and inherent integrity risk
- System and process design
- ALCOA+
ZES director David Easton, said: “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.
“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 three-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.”
