Starting point
A complex process control system in human pharma production requires annual periodic reviews. Up to 600 change requests per year in an MS Access database and the change management system overwhelm manual extract processes.
Paper documentation must also be checked against GxP documentation rules. Delays jeopardise the demonstrated validated state ahead of authority inspections.
Approach
cube one automated assignment and assessment of change requests from MS Access and TrackWise and standardised the review workflow.
Automating the extract
- Automated assignment and assessment of change requests in MS Access and TrackWise.
- Extract process maximised; errors minimised through clear guidance.
- Regular execution on fixed Q1 cycle established.
GxP documentation review
- Paper documentation checked against GxP documentation rules.
- Work sits in system review and computer system validation.
- Maintained validated state documented.
Result
Process quality
- Extract process maximised.
- Errors in periodic review execution minimised.
- Annual periodic review completed on time.
Compliance
- Validated state of process control system maintained.
- Paper documentation checked for GxP conformity.
- Related: SYSPRO CSV under Annex 11.
TrackWise: Wolters Kluwer.