Data integrity and sample traceability
The system records who did what and when for changes to the main records and results, plus system logins. Corrections record the change and keep the previous value. These records support the ALCOA+ principles adopted by the laboratory.
Illustrative system screen. Demo data that does not represent client results.
What you'll find in this area
Change history.
Changing a result records the author, the date and the values before and after the change.
Audit trail.
The application only appends entries to the trail, without editing earlier ones, and the minimum retention is 5 years.
Sample traceability.
Each sample has a unique ID and a history of its stages, from receipt to disposal.
Role-based access control.
Profiles define who can view, create, edit or delete. The session ends after a period of inactivity.
Attributed actions.
Each user logs in with their own identity, and recorded actions are linked to whoever performed them.
Cancellation with a reason.
Cancelling a sample requires a reason, which is saved with the record.
From proposal to report.
Proposal, sampling, analysis, review and report are linked, which helps rebuild each sample's path.
How the system supports ALCOA+ principles
ALCOA+ is a set of data integrity principles. The system provides records that support these principles. Procedures and validation for the intended use belong to the laboratory.
Attributable and contemporaneous.
Each record keeps who did it and when, at the moment it happened.
Original and accurate.
A correction records the change and keeps the original value instead of overwriting it.
Legible and enduring.
The history stays searchable over time, with a minimum retention of 5 years in the audit trail.
Frequently asked questions
Can a result be changed without leaving a record?
In the monitored records and results, a change records who changed what and when, and the previous value is kept. The trail covers the monitored records and logins, not all system data.
How is each action attributed to someone?
Through role-based access control. Each user logs in with their own identity, and the action is recorded under the name of whoever performed it.
Can I rebuild a sample's path?
Yes. Each sample has a history from receipt to disposal, with the reason recorded for cancellations. Proposal, sampling, analysis and report are linked.
Is ALCOA+ a feature I turn on?
No. ALCOA+ is a set of principles. The system provides features that support them, such as the audit trail, access control and change history. Validating the system for its intended use is done by the laboratory.
Want to see the QMS with your laboratory's routine?
Free online demo, about 30 minutes long. Our team adapts the examples to your laboratory's routine.