Annual Product Reports
Controlled APQR and EU PQR outputs from approved templates.
Annual Product Reports generates the final controlled APQR and EU PQR documents from approved templates, formatted to the section structure each regulator expects and issued as a locked, exportable record.
What Annual Product Reports delivers
A controlled path from start to closure
- 1Select Template
- 2Auto-Populate
- 3Add Assessment
- 4Approve
- 5Issue
- 6Distribute
Why teams move to Annual Product Reports
Generate regulator-ready reports without manual formatting
Produce FDA and EU report variants from the same underlying data
Cut report preparation time from weeks to days
Ensure every issued report matches an approved template
Maintain a retrievable archive of every issued 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.