COA Generation
Certificates generated from approved results with electronic signature.
COA Generation produces the Certificate of Analysis directly from approved, signed results, eliminating retyping and ensuring the certificate always matches the electronic record it was built from.
What COA Generation delivers
A controlled path from start to closure
- 1Approve Results
- 2Select Template
- 3Generate Certificate
- 4Sign
- 5Issue
- 6Archive
Why teams move to COA Generation
Remove retyping errors between results and certificates
Issue certificates as soon as results are approved
Guarantee the COA matches the signed electronic record
Support customer-specific certificate formats
Keep a controlled history of every certificate issued
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.