Audit trails and data integrity
Capture accountable activity, history, and evidence around quality records and process work.
Quality and GxP foundations
The quality-system controls serious operations are expected to make visible.
INQ. brings the practical foundations of electronic quality management into a Microsoft 365 operating environment. The right control outcome still depends on the applicable standard, configuration, intended use, validation, and customer procedures.
Security and access control
Use Microsoft 365 identity, role and group-based permissions, and controlled administrative actions.
Electronic approvals and signatures
Support approval workflows with identity-aware controls and a clear relationship between the action and the record.
Controlled documents and records
Manage document states, versions, numbering, permissions, linked documents, and change history.
Notifications and action visibility
Keep assigned work, comments, status, due dates, and process activity visible to the people responsible.
Reporting and operational insight
Use registers, dashboards, SharePoint-native data, and customer-delivered Power BI reporting to support oversight.
Applicable quality contexts
One control foundation, applied to the standards your operation works under.
GMP foundations
Interpret GMP, Annex 11, Part 11, data integrity, backup/recovery, validation, and CSV decisions.
Explore the interpretationISO 9001 foundations
Interpret documented processes, responsibilities, corrective action, records, change, and continual improvement.
Explore the interpretationISO 13485 foundations
Interpret medical-device QMS, risk, training, records, corrective action, and controlled change.
Explore the interpretationFood-quality foundations
Interpret HACCP and food-quality procedures, traceability, corrective action, and customer-specific requirements.
Explore the interpretationA practical compliance conversation
Standards describe the control context, not a software badge.
Whether the context is ISO 9001, ISO 13485, pharmaceutical GxP, or food quality, a fit assessment should look at the complete operating model: identity, signatures, audit trails, permissions, validation, change control, retention, backup, and the procedures around the system. Part 11 and Annex 11 are regulatory control frameworks, not guarantees supplied by a product name.
Questions worth answering
- How are records attributed, reviewed, approved, and retained?
- Who can access, change, reassign, or cancel quality work?
- How are configuration, process, and document changes controlled?
- What validation, UAT, and operating procedures are required for the intended use?
Next step
Review the controls that matter for your intended use.
Bring your quality processes, evidence expectations, and Microsoft 365 context to a focused product conversation.