Computer system validation
A validation can’t close on tests nobody ran.
Write, sign off and execute validation protocols for any computerized system —the LIMS, a piece of equipment, scale software or the ERP— with evidence that can’t be altered.
What it does
From protocol to report, with the evidence inside.
A protocol is written, approved and only then executed, so you always know how many steps remain.
Protocols
- Versioned protocols: draft, effective and obsolete
- Approval with e-signature and a hash of what was signed
- Steps with what is tested and the expected result
- Complete version history
Execution
- Run from an approved protocol or from scratch
- The application under test runs inside the screen, with capture and annotations
- Screen recording with optional narration
- Attachments such as logs, CSVs or certificates, identified by hash
Results
- Actual result and pass or fail verdict per step
- Overall progress kept separate from the outcome
- PDF report that separates protocol steps from added ones
- Separate permissions for approvers and testers
Connected
It shares the record with the rest of the suite.
Modules aren’t integrated through exports: they work on the same batch data.
Evidence is stored in the document repository, with the same e-signature as the rest of the suite.
LIMSLaboratoryThe laboratory is one of the systems you can validate from here.
QMSQuality managementShares the e-signature and the immutable record model.
Compliance
Regulations it supports.
Electronic signatures and the audit trail are the same across the suite.
See the compliance matrix- 21 CFR Part 11
- E-signed protocols and evidence that can’t be altered.
- CSV · GxP
- Computer system validation with protocols approved before execution.
See a validation with the evidence on screen.
We’ll walk you through the module with a case like yours and show how it connects to what you already use.