Find the context
Follow a product's history instead of piecing together disconnected logs.
Audit readiness
Can we answer an auditor's questions without reconstructing the story?
Give your team a connected production record and a clear account of controlled changes, so a review starts with evidence your people can explain.
A practical path from record to decision
- Production historyProduct, process and material context
- Change historyWho changed what, and when
- Controlled reviewPermissions and signature policies
- Your evidenceRecords assessed against intended use
Explain a change
Inspect recorded changes and their attribution.
Prepare deliberately
Align access and approval policies with the way your operation is governed.
A record is useful when your team can explain how it came to be.
An audit question can span production, quality and engineering: which recipe was used, what happened to a suspect unit, and who approved a change? A collection of files rarely tells that story on its own. IntelliTrack™ connects production evidence with the history of controlled actions.
How it works in IntelliTrack™
Follow the record. Review the change. Explain the decision.
Find the production context
Start from a serial number, lot or relevant report and inspect the operations, materials and results associated with it.
Inspect the controlled action
Use the audit trail to review recorded changes, including attribution, time and the available before-and-after values or reason.
Review under your policies
Apply configured roles and electronic-signature policies to relevant actions. Review the evidence under your approved procedures.
Illustrative manufacturing scenario
A recipe change with a production history behind it.
During a record review, a quality engineer needs to explain which recipe governed an assembly and how a later change was approved. The useful outcome is an inspectable chain of records, without treating the latest recipe as the one used for every historical unit.
Production history
What you can inspectThe recipe context and results captured for the unit.
Your team's decisionDetermine whether the record supports the manufacturing decision.
Audit trail
What you can inspectRecorded configuration or quality changes and their attribution.
Your team's decisionInvestigate unexpected changes and document the review.
Electronic signatures
What you can inspectSignatures for the actions covered by configured policies.
Your team's decisionCheck that the required authority and meaning match your procedure.
Set up the workflow around your process.
- Define user roles, controlled actions and applicable signature policies, including GxP mode where used. Individual accounts and appropriate access management support meaningful attribution.
- Plan retention, time synchronization, database access, backup and recovery with your IT team. An application audit trail is part of the record-control approach, not a substitute for these controls.
- Your organization determines applicable requirements and validates the configured system for its intended use. Software features alone do not establish regulatory compliance.
Practical questions
What to know before you start.
Does IntelliTrack™ make our operation compliant automatically?
No. It provides record, access and signature capabilities that can support your quality system. Your procedures, configuration, intended-use validation, training and ongoing controls determine how those capabilities meet your requirements.
Are electronic signatures applied to every action?
Signature requirements depend on the applicable mode and configured policies. Identify the actions that need approval and test both authorized and unauthorized paths during your evaluation.
Can we inspect historical values after a configuration change?
The audit trail records changes supported by the audited workflow, and production records retain their associated context. Review the specific fields and actions important to your process rather than assuming every possible database change is captured.
Can users edit the audit trail through the application?
The audit trail is presented as a read-only review record. Database administration and infrastructure access still need controls; do not treat application access rules as protection against every possible administrator action.
What should we bring to a demonstration?
Bring a representative record request and an approval procedure. We can follow a production record, inspect an associated change and show how access and signatures would be configured.
Explore audit readiness with your own process.
Bring a representative production example. We can walk through the records, configuration and responsibilities your team would need.