Reagent Traceability
Reagent lot, preparation and expiry captured against each use.
Reagent Traceability captures the lot number, preparation details and expiry status of every reagent used in an experiment, so any result can be traced back to exactly what was used to generate it.
What Reagent Traceability delivers
A controlled path from start to closure
- 1Select Reagent
- 2Verify Expiry
- 3Record Lot
- 4Use in Experiment
- 5Track Consumption
Why teams move to Reagent Traceability
Trace any result back to the exact reagent lot used
Prevent use of expired or recalled reagents
Identify affected experiments quickly during a reagent recall
Support investigations with complete reagent history
Keep certificate of analysis evidence attached at point of use
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.