Create and edit validation records
Kneat’s Editor allows you to create any validation record, or validation record template, author a document from scratch or import a word document. Define document types associated with stages in a process or project and arrange them into any specified order.
- Manage folders and documents with unique identifiers.
- Import Word documents to quickly create a Kneat smart document or template.
- Add re-usable content to a document from a library e.g. test cases.
- Import data from Excel.
- Export to a locked down and non-editable format.
- Insert a reference or hyperlink within a document to any other document within the system.
- Upload any attachment file type into a document such as evidence during testing.
Review and approve with ease
Kneat’s Inbox area allows a user to view and navigate to documents they have received for Review or Approval. Quickly filter the Inbox to view documents or forms by status, ‘in progress’, ‘complete’ and more. When selecting a document from Kneat’s Inbox, the document will launch and the user can review it or set an approval status.
- Issue a document for review, email notifications alert users.
- Real time, in-document commenting between document reviewers.
- Automated version management throughout.
- Document owner can update to new version while in-review.
- Issue a document for approval to users, email notifications alert users.
- Approve with 21 CFR Part 11 / Annex 11 compliant electronic signature.
- Approvers can review all document information, including any document changes complete with reviewer comments.
- Reject a document and provide comment.
- Re-open an approved document for modification and version management is auto applied.
Test execution without paper
When a test document has been pre-approved, it may then be issued for execution. Testers can enter recorded results, create and process any exceptions, upload evidence, apply electronic signatures and generate summary reports without ever going to paper. Capture any subsequent changes to test data complete with e-signature, time stamp, and a reason for change – all while automatically generating a full audit trail.
- Execute testing and sign using compliant electronic signatures.
- Multiple users can test within the same protocol simultaneously.
- Attach an unlimited number of file attachments, screen shots to a test row, test section, test script etc.
- Apply a witness signature to any test step/script if required.
- View the full history of a test and all associated events.
Electronic Logbook Management
Kneat’s Electronic Logbook Management feature, eLogbook, is included in all Kneat Gx versions, with no additional software or hardware purchases, installation or qualification required. Simply setup the electronic logbook work process in your Kneat Gx application and start logging.
- Logbook forms based on your procedures
- Real-time equipment and cleaning data and status reports from anyplace
- Complete Life-cycle management in one 21 CFR Part 11/Annex 11 application
- All supporting documentation, just a click away
- Comprehensive, time-stamped, author-attributed logbook history
Instant document search and audit trail
Kneat automatically generates an independent detailed, un-editable audit trail in real time. See any user action, correction or change with a corresponding timestamp, and a range of other particulars at the click of a mouse. Filter and re-order any audit trail to pinpoint any desired information during audit, including:
- Revision history for any document either in review, pre-approval, or test execution.
- Document events such as document creation or deletion, or issued for approval.
- Document template events such as a document template being issued for approval.
- Template dispositioned by signatory.
- Test execution events such as saved, or modified test data.
- Administration events such as login, create user, or edit user details.
- Security events such as failed login.
For all your validation needs
Use Kneat to digitize and manage any validation, commissioning or qualification process.
A complete solution that can scale to meet all your validation needs across all of your facilities globally.
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