Area Cleaning Records
Room and line clearance recorded with verification signatures.
Area Cleaning Records document room and production line clearance between batches and products, capturing verification signatures and preventing the next batch from starting until clearance is confirmed.
What Area Cleaning Records delivers
A controlled path from start to closure
- 1Initiate Clearance
- 2Complete Checklist
- 3Attach Evidence
- 4Verify
- 5Release Line
Why teams move to Area Cleaning Records
Prevent batch start before the line is confirmed clear
Provide photographic and signed evidence of clearance
Reduce cross-contamination risk at product changeover
Standardise clearance checks across lines and shifts
Speed up changeover without skipping verification steps
Built for regulated operations
21 CFR Part 11
Electronic records and electronic signature controls — unique user identity, secure e-signatures and computer-generated audit trails on every record.
EU GMP Annex 11
Computerised system controls including access management, change control, data integrity and periodic review of the system.
GAMP 5
Risk-based validation approach, with pre-executed IQ/OQ documentation supplied with every release.
ALCOA++
Records that are attributable, legible, contemporaneous, original and accurate — enforced at record level.
OPS IQ is designed to support these regulatory expectations. Compliance is achieved together with your own validated implementation, procedures and controls.
Connected to your enterprise systems
ERP / SAP
Master data, materials and batch context exchanged over open REST and event APIs.
MES
Shopfloor execution events and equipment context linked to quality records.
LIMS
Laboratory results and specification data connected to quality decisions.
Identity Providers
Enterprise SSO and role-based access through your existing identity provider.
Enterprise APIs
Open REST and event APIs for custom and legacy systems.