Audit Management
Internal, supplier and regulatory audits with findings and follow-up.
Audit Management covers the full audit cycle — annual planning, scheduling, checklist execution, findings and observations, corrective actions and follow-up — so audit evidence is complete and retrievable at any time.
What Audit Management delivers
A controlled path from start to closure
- 1Plan
- 2Schedule
- 3Execute
- 4Findings
- 5Actions
- 6Follow-up
- 7Close
Why teams move to Audit Management
Run internal, supplier and regulatory audits from one plan
Standardize checklists across sites
Track every finding to a closed action
Cut audit report preparation time
Improve inspection readiness with retrievable evidence
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.