Starting point
A food manufacturer needed a cross-system DI assessment across production and process control, LIMS and change control systems, including a complete system inventory as the basis.
In parallel cube one ran a structured DI gap assessment on validated GxP software: missing audit trail filter and insufficient session isolation when the application was locked. Both programmes address regulatory inspection risks ahead of authority review.
Approach
The assessment followed GAMP 5 and 21 CFR Part 11. Findings were prioritised, communicated and tracked through to verification.
Food manufacturer assessment
- Assessment of production and process control systems for ALCOA++ conformity.
- LIMS analysis regarding audit trail, access controls and data security.
- Review of change control systems; complete system inventory as basis.
- Prioritised findings and action plan with owners and timelines.
Service line: data integrity consulting.
GxP software vendor gap assessment
- Identification of critical compliance gaps at the software vendor.
- Formal communication of findings and close tracking of gap closure.
- Final verification after patch release in the validation dossier.
Related: supplier qualification FDA.
Result
Food manufacturer
- DI status of all relevant systems fully captured and assessed.
- All assessed systems meet requirements for authority and internal inspections.
- Concrete action plan with defined owners handed over.
Software vendor
- All identified compliance gaps remediated by the vendor.
- Fully audit-ready documentation of findings and measures.
- Re-assessed after patch release; no open DI risks remained.
Related: data readability and data archiving.