Complaint Management
Market complaint intake, investigation and regulatory follow-through.
Complaint Management records market and customer complaints, classifies them for reportability, drives investigation and root cause, links CAPA and tracks regulatory follow-up through to closure and trending.
What Complaint Management delivers
A controlled path from start to closure
- 1Intake
- 2Classify
- 3Investigate
- 4Root Cause
- 5CAPA
- 6Regulatory Follow-up
- 7Closure
Why teams move to Complaint Management
Capture complaints from every channel in one queue
Meet internal response timelines with automated escalation
Link complaints to batches, deviations and CAPA
Reduce complaint cycle time
Trend complaints by product, defect type and market
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.