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US NEXA | EAM Now Offers Paperless Validation
Benefits of Paperless Validation
Improve CollaborationOnline Editor: Modify protocols and summary reports in real-time with coworkers, and Transcat's assigned compliance engineer. Comment/Chat: Leave detailed comments that require resolution prior to routing the document for approval or use the informal chat feature to discuss the document. Serial and Parallel review/approval paths: Automate the review and approval paths to each designee either sequentially or concurrently to multiple signers. Final deliverable is a single PDF: Electronic execution of the document allows it to be easily copied and shared. |
Faster Cycle TimesElectronic Routing for Review/Approval Instantly route across departments, buildings, and remote locations Eliminates delays to ship physical hard-copy records Remote worker friendly Equipment is qualified and back in service ahead of slower hard-copy processes |
Eliminate Waste
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Feel confident sending auditors paperless validations as a single, easy-to-read PDF |
Finish your qualification projects ahead of schedule |
Save approximately 5 hours of labor per qualification |
Paperless Validation – Digital delivery
NEXA | EAM utilizes VALGENESIS, the industry standard for paperless validation.
- The system is validated to 21 CFR Part 11
- It reduces cycle times by automating and digitizing the Review/Approval processes
- It offers improved Data Integrity (ALCOA):
- User/Date/Time is recorded for every entry (Attributable)
- Poor penmanship of hand-written entries are eliminated (Legible)
- Backdating is no longer possible with auto generated date/time of each entry (Contemporaneously recorded)
- Digital security features include blue watermark at right margin, post execution cover page, and a full audit trail. (Original/ True copy)
- Simplified digital review process decreases the time needed to verify accuracy of qualification data (Accurate)
- Entire qualification package presented in a single PDF.
- Accessible via SECURE internet connection, via Microsoft Azure
Protocol Generation / Review / Approval
- Routed electronically via Serial or Parallel paths (Reviewed by multiple users simultaneously)
- E-mail notifications for review & approvals
- Review allows real-time editing / comments
- Comments must be marked as resolved before routing for approval
- All review edits/notes are recorded in the Audit Trail
Protocol Execution
- Allows for digital or hard-copy executions
- All electronic signatures are compliant to national standards
- Split executions permitted (Execution by multiple engineers if needed)
Post Execution Review
- Routed electronically via Serial or Parallel paths
- All attachments are labeled and combined into a single PDF
Qualification Summary Report
- Detailed QSR are routed for review/approval in Valgenesis
- View executed protocol and attachments when approving QSR
Record Retention
- All qualifications are maintained in Valgenesis, and the final PDF is published to C3Transcat.com for record retention.
Valgenesis System Access
- Each validation quote includes one free 30-day user license for the review and approval of qualification documents during the active validation project. Licenses for additional users or user extensions are available upon request.
Contact our dedicated team for more information at Compliance@Transcat.com