Laboratory / Quality
Contract laboratory testing programme
Setting up release and stability testing at a contract laboratory for a new product.
Illustrative use caseIllustrative use case
Pharmaceutical data intelligence
Bringing batch, laboratory and quality data together for trending and product review.
Challenge
Annual product reviews required weeks of manual data collection.
Requirement
Trusted, structured data and repeatable trend reports.
Approach
Define the data model, extract from source systems with integrity checks, and build trend dashboards.
Process & execution
- 1Data inventory
- 2Data model
- 3Extraction & checks
- 4Dashboards
- 5Review
- 6Periodic update
Technology / process
- Data warehouse
- Dashboards
- Statistical trending
Documentation
- Data flow diagram
- Report specifications
- Verification records
Verification
Dashboard values reconciled with source records.
Outcome / expected benefit
Expected benefit: product reviews assembled in days, not weeks.
This is an illustrative use case describing a typical project structure. It does not describe a specific client, product or completed engagement.
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Digital / Manufacturing / Software
Electronic batch record concept
Designing the move from paper batch records to electronic execution with review by exception.
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Software / Quality / Digital
Pharmaceutical document management system
A controlled document lifecycle with review, approval, effective dates and archive.
Illustrative use case