Digital / Manufacturing / Software
Electronic batch record concept
Designing the move from paper batch records to electronic execution with review by exception.
Illustrative use caseIllustrative use case
Pharmaceutical training management platform
Course, module, assessment and certificate management linked to controlled documents.
Challenge
Training on revised SOPs lagged behind their effective dates.
Requirement
Automatic training assignment when documents change, with assessment evidence.
Approach
Link document revisions to training curricula by role, add assessments and certificates.
Process & execution
- 1Course
- 2Module
- 3Training
- 4Assessment
- 5Completion
- 6Certificate
Technology / process
- LMS
- DMS integration
- Role curricula
Documentation
- URS
- Test scripts
- Validation report
Verification
Assignment, assessment and certificate generation tested for each role.
Outcome / expected benefit
Expected benefit: staff trained before a revised procedure takes effect.
This is an illustrative use case describing a typical project structure. It does not describe a specific client, product or completed engagement.
More use cases
Software / Quality / Digital
Pharmaceutical document management system
A controlled document lifecycle with review, approval, effective dates and archive.
Illustrative use caseQuality / Digital / Software
eQMS workflow digitisation
Moving deviation, CAPA and change control from paper forms to linked electronic workflows.
Illustrative use case