NEXA | EAM Now Offers Paperless Validation
Benefits of Paperless Validation
Online 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 Times
Electronic 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
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
- 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
- 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.