Remediation

15/02/2024

Data Integrity Remediation

Cheshire Scientific Service offer a wide range of bespoke services for the pharmaceutical and biotechnology sector. As such we were able to support our global vaccine producing client with preparation, execution and reporting of computer system validation (CSV) and data integrity remediation work as part of a site remediation project. Equipment scope was SCADA/PLC based manufacturing process and QC equipment. The completion of this project gave the client confidence to engage with health authority inspections around data integrity challenges

Data Integrity Remediation

Legacy Remediation

A global audit of this small molecule testing facility identified gaps in software and analytical method template validated status across several areas of the testing laboratory. Cheshire Scientific services were tasked with re-validation of GMP laboratory software and equipment, including analytical method template re-validation as part of an authored data integrity remediation plan.

Legacy Remediation
Legacy Remediation