CONSULTING SERVICE
GxP Equipment Data & Integration Assessment
Plan trustworthy equipment and instrument data connections for pharmaceutical and other GxP manufacturing workflows.
When this helps
- An instrument-to-MES or laboratory system connection
- A production data path needing clearer record ownership
- A brownfield integration with quality and verification requirements
What the work covers
| Stage | Work |
|---|---|
| Define intended use | Agree with process and quality owners on the records and decisions involved. |
| Trace the data | Map values, units, timestamps, equipment, batch context and receiving systems. |
| Review controls | Assess access, change history, reconciliation, retention and failure handling in the intended workflow. |
| Plan verification | Connect requirements and risks to evidence, reviewers and release gates. |
What you receive
- Equipment-to-record architecture and record inventory
- Requirements and ownership matrix
- Risk and gap register
- Verification, change and handover plan
What your team provides
Provide process and quality owners, approved requirements and procedures, applicable record obligations, system information and a permitted test approach.
Schedule and engagement
Schedule is agreed around document access, quality review and site change procedures. Production release remains within the client’s controlled process.
Buntop provides integration and validation support within the agreed scope. This is not a certification or a guarantee of regulatory compliance.
Quality ownership and record requirements
Quality and process owners determine applicable requirements and approve the intended use. Part 11 applicability depends on the electronic records involved and the underlying record requirements. Evidence and approvals belong in the client’s controlled quality system.
Review topics may include data integrity, electronic records, signatures where applicable, and the client’s risk-based validation approach. The website and demonstration apps are planning tools, not a validated record system.