某生物制造企业 · Anonymised, no written authorisation
Batch records: merging three data sources into one batch
Batch record
One per batch
A batch no. maps to one e-batch-record
Change history
Full audit
Original values kept, deviations closed-loop
Audit prep
Per-batch export
From archives to one-click export
Problem
Batch data sat in DCS, paper records and spreadsheets; audits required manual reassembly. Critical parameters were transcribed by hand — transcription itself is a risk. Deviations had no single workflow from report to closure, so root causes got lost, and SOP versions drifted on the shop floor.
Approach
Single-product pilot: batch data collected automatically from equipment and systems, critical parameters captured with person, time, equipment and version attached; templated batch records — one batch number, one complete record; SOPs pushed electronically to workstations under version control; one workflow from deviation report through investigation to closure; integrated with ERP and third-party equipment; e-signatures configured to the customer quality system.
Outcome
One batch number maps to one complete electronic batch record: original values traceable, modifications audited, deviations closed-loop. Audit preparation turns from digging through archives to exporting per batch. The structure comes from delivery practice across pharmaceutical and bio-manufacturing projects, covering error proofing, in-process quality alerts and system integration.
Can be interrogated
Why one product first?
A single product exposes about 80% of the data structure problems without disturbing other lines. Starting with many at once makes failures impossible to attribute.
How does equipment data get in?
Through collection gateways connected directly to DCS/PLC and third-party equipment; critical parameters are captured automatically, never transcribed. Scope and interfaces are confirmed during assessment.
How are electronic signatures handled?
Configured to the customer quality system, bound to person, time and record version, and not editable after the fact.
Do we keep the paper records?
Kept in parallel during rollout, then handled per the customer quality documentation. We do not decide retention periods for them.