Recall Management
Recall initiation, traceability and effectiveness reporting.
Recall Management supports controlled execution of product recalls and market actions — identifying affected products and batches, planning and communicating the recall, monitoring effectiveness and reporting to authorities.
What Recall Management delivers
A controlled path from start to closure
- 1Initiate
- 2Identify Product & Batches
- 3Plan
- 4Communicate
- 5Monitor Effectiveness
- 6Report
- 7Close
Why teams move to Recall Management
Trace affected batches quickly
Coordinate recall communication from one record
Evidence recall effectiveness checks
Produce regulatory reporting packs faster
Retain a complete recall history
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.