Environmental Monitoring Logs
Viable and non-viable monitoring records captured by area and grade.
Environmental Monitoring Logs capture particle counts, viable monitoring and area conditions on schedule for every classified space, checking results against limits automatically and flagging excursions the moment they occur.
What Environmental Monitoring Logs delivers
A controlled path from start to closure
- 1Schedule Point
- 2Sample / Read
- 3Compare to Limit
- 4Flag Excursion
- 5Investigate
- 6Trend
Why teams move to Environmental Monitoring Logs
Detect environmental excursions the moment they occur, not on review
Replace manual limit checking with automatic flagging
Provide a defensible trend history for regulatory submissions
Reduce the risk of undetected classified-area deviations
Cut the time spent compiling EM data for periodic review
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.