Design with manufacturing and QA
I worked with operational and technical stakeholders to translate quality requirements into the architecture and implementation.
Manufacturing data & quality traceability
A data-integration and quality-management solution for pharmaceutical manufacturing, supporting Continued Process Verification and quality investigations.
- My role
- Solution architect, Flame-Ware Solutions
- Delivery stage
- Production
- Customer
- Anonymised
THE CUSTOMER PROBLEM
What needed to change.
A pharmaceutical manufacturing customer needed consolidated process data to support Continued Process Verification, consistent quality reporting and traceability during quality investigations.
MY RESPONSIBILITY
What I owned.
Defined the architecture and SQL Server data models, implemented integration interfaces and led automated collection, validation, reporting and audit trails. Worked with manufacturing, QA and technical stakeholders on data integrity and traceability.
CONSTRAINTS & PRIORITIES
What shaped the approach.
- Manufacturing, QA and technical stakeholders needed a common understanding of data mapping and reporting requirements.
- GxP-related requirements had to be translated into data integrity, traceability, role-based access, change control and validation documentation.
- Data collection, validation and reporting needed to support process trends, deviations and investigation workflows.
ARCHITECTURE & DELIVERY
How the work fitted together.
- 01
Collect and integrate process data
Integration interfaces and automated collection consolidated manufacturing process information.
- 02
Model and validate the data
SQL Server data models, data validation and audit trails supported integrity and traceability.
- 03
Support quality investigations
Reporting, process trend analysis and investigation workflows made the consolidated data usable by manufacturing and QA stakeholders.
TECHNICAL JUDGEMENT
Decisions and responsibilities.
Include traceability in the data design
Automated validation, audit trails, access controls and change control were part of the solution's data-integrity approach.
Carry the integration into production
My scope included technical implementation, development leadership, integration testing and production deployment.
THE RESULT
What was delivered.
Improved manufacturing-data visibility, standardised quality reporting and reduced manual consolidation.