Know who did what
Record submissions, approvals, rejections, changes, and check-ins against an identifiable person, with a server-side time record that can be reviewed later.
Quality and GxP foundations
A quality system you can trust when critical decisions matter.
When a critical quality decision has to be made, the records need to be there, correct, attributable, and ready to review. INQ. helps teams keep the evidence clear: who did what, when they did it, which version was used, what was approved, and what changed, in a Microsoft 365 operating environment.
INQ. provides configurable platform controls. Your organisation remains responsible for intended use, procedures, risk assessment, validation, training, and the evidence required for its operating context.
The controls behind that trust
Make the evidence clear before the decision is critical.
Know which version is current
Keep document versions, effective dates, change history, and linked records clear so people can see what was approved and what is in use.
Keep evidence complete and readable
Preserve records and their history so the evidence remains attributable, legible, contemporaneous, original, accurate, and available for review.
Control access and authority
Use Microsoft 365 identity, role and group-based permissions, and controlled administrative actions so people can only perform the work they are authorised to do.
Tie approvals to the right record
Keep approval decisions, signatures, comments, and outcomes connected to the quality record or document they concern.
Make the process visible
Show assigned work, status, due dates, notifications, comments, and process activity so teams can act, review, and follow up.
Applicable quality contexts
Start with the standards and operating context your organisation works under.
The core INQ. controls remain stable. The risks, evidence expectations, validation decisions, and operating procedures depend on your quality context and intended use.
GMP foundations
Interpret GMP, Annex 11, Part 11, data integrity, CSV, and validation decisions.
Explore the interpretationISO 9001 foundations
Connect documented processes, responsibilities, corrective action, records, change, and improvement.
Explore the interpretationISO 13485 foundations
Consider medical-device quality processes, risk, training, records, corrective action, and controlled change.
Explore the interpretationFood-quality foundations
Explore food-quality procedures, traceability, corrective action, supplier evidence, and customer requirements.
Explore the interpretationWhy these controls matter
Good records make decisions and responsibility visible.
An audit trail is useful because it shows the history of a record, not simply because a system has a log. Version history prevents people from working from an obsolete document. Attributable approvals show who accepted a decision. Controlled access reduces the chance that the wrong person changes the wrong record. Together, these controls support evidence that is trustworthy and usable when a team needs to investigate, review, or demonstrate how work was completed.
Questions worth answering
- Can we show who created, changed, reviewed, approved, or rejected each record, and when?
- Can people identify the current approved version and see what changed from the previous version?
- Who can access, change, reassign, or cancel quality work, and how is that authority controlled?
- What evidence must be retained, reviewed, and tested for our intended use?
Next step
Review the controls your intended use depends on.
Bring your quality processes, evidence expectations, and Microsoft 365 context to a focused product conversation.