Data-integrity (ALCOA+) review completed

Data integrity is the foundation of a pharmaceutical quality system: a batch is only as trustworthy as the records that describe how it was manufactured and tested. Over recent months, a cross-functional team drawn from Quality Assurance, Quality Control and IT at the Ergopharm Advanced Research Centre reviewed how records are generated, captured, reviewed and archived, mapping each control point against the ALCOA+ expectations. ALCOA sets the baseline that data be Attributable, Legible, Contemporaneous, Original and Accurate; the plus extends this to Complete, Consistent, Enduring and Available. The review covered both paper-based documents, such as Batch Manufacturing Records and analytical worksheets, and electronic sources, including chromatography and environmental-monitoring systems.

“Trustworthy manufacturing begins with trustworthy records, and ALCOA+ is the standard against which Ergopharm holds its own data.”

Attributability was examined first: every entry, correction and approval must be traceable to a named, trained individual. The team verified that user accounts are unique, that shared logins have been removed on affected systems, and that access rights are aligned to role. Contemporaneity was tested by confirming that records are made at the time an activity is performed rather than reconstructed afterwards, and that system clocks are synchronised and protected so date-and-time stamps cannot be altered by operators. Completeness was assessed by tracing selected batches end to end, checking that raw data, metadata and audit trails are retained alongside the reported result, and that no original observation is discarded once a value has been recorded.

The review supports the wider pharmaceutical quality system described in ICH Q10, feeding directly into the elements of process and product monitoring, corrective and preventive action, change management and management review. Where minor gaps were identified, they were logged through the site's deviation and CAPA processes, with changes to procedures and system configuration handled under formal change control. Findings and remediation status were escalated to senior management as part of the periodic quality review, ensuring accountability at the level required to sustain the improvements.

The practical benefit is a more defensible record trail behind every Certificate of Analysis and Qualified Person release. Robust, review-ready data integrity underpins Ergopharm's serialisation and traceability commitments and its readiness for external inspection, and it strengthens the assurance that each serialised, prescription-only pack has been manufactured and tested exactly as its records state. Figures and scope described here are illustrative of the site's own processes.