Complaint Analysis
Complaint categories, rates per million and confirmed defects.
Complaint Analysis summarises market complaints received against a product during the review period, normalising volume against units dispatched and separating confirmed defects from unconfirmed or unrelated reports.
What Complaint Analysis delivers
A controlled path from start to closure
- 1Aggregate Complaints
- 2Classify
- 3Normalise Rate
- 4Compare Periods
- 5Summarise
- 6Report
Why teams move to Complaint Analysis
Give reviewers a normalised, comparable complaint rate
Separate confirmed defects from noise in the complaint data
Reduce manual reconciliation of complaint records for the review
Support faster identification of market quality trends
Strengthen the review's market performance narrative
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.