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Learning How a 21 CFR Part 11 Software Can Greatly Help Your Business

ValuTrack eases up the requirements and also presents solutions to meet regulations of FDA’s 21 CFR Part 11 software.


KJ Steinhoff went in Boston on Wednesday, October 5, 2011 at 12:00PM(EST) to attend Introduction to 21 CFR Part 11 Compliance: The Regulations and Your Solution. Hosting the event was Dave Janelle from ValuTrack. Doug Niemeyer, Sales Director at Teklynx and Tony Raymond, Founder and Principal consultant, New Harbor SQA attended this webinar.
The webinar presented the insights and solutions for compliance with the government requirements for record-keeping and signature capturing.
Doug and Tony presented ValuTrack’s total enterprise label management solution: Teklynx Central CFR Software with Zebra Printer Solutions.
The Teklynx Central CFR Solution includes:

  1. Label designer that designs label using information from a file or a database to help create complicated bar codes such as HIBC or GS1 Databar, to meet the industry standards of Healthcare and Pharmaceuticals.
  2. Module for label approval which improves the label designs using electronic signatures, while getting the needed security and traceability to comply with FDA 21 CFR Part 11.
  3. Module for automated printing network to help manage multiple printers in several locations using just one server.
  4. Reporting options providing complete documentation and activity log for easy management and traceability.
  5. Interface for label selection and internet printing around the world (browser-based).
  6. Command center to coordinate the enterprise labeling process and provide secure access and user profile controls. 

The benefits of Teklynx Central CFR Installation:

  • Electronic records, record retention and retrieval are more secured.
  • Audit trails are recorded.
  • Electronic Signatures are captured.
  • User privileges are assigned on various user types.
  • Computer systems are more validated. 

For additional information, please visit us at, or call 866-825-8382.


 21 CFR Part 11 Software

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