ValuTrack - Label, Scan, Manage

Industry Solutions 21 CFR Part 11 Compliance

21 CFR Part 11 Compliance

Powerful Tools for Life Sciences Applications

l_teklynx.jpgValuTrack and TEKLYNX International provide an off-the-shelf global labeling and management system (regulatory compliance software) that meets the Food and Drug Administration’s (FDA) 21 CFR Part 11 regulation. With its release in 1997 of 21 CFR Part 11, the FDA specified its requirements for accepting electronic records in lieu of paper records. If you are tasked with complying with FDA regulations and doing so by electronic records, then 21 CFR Part 11 applies to your business.

Watch the video below for a complete overview of our FDA regulatory compliance solution.

Teklynx Life Sciences Solutions 

TEKLYNX International, the world’s leading developer of Automatic Identification and Data Collection (AIDC) software, has developed a fully audited off-the-shelf 21 CFR Part 11 compliant solution addressing the needs of Life Sciences companies in the areas of:

  • Label Design & Development
  • Quality Control & Label Archive
  • Global/Local Printer Management
  • Web Based User Interface

The TEKLYNX Life Sciences label management solution is a validated labeling solution including auditable security protocols and lifecycle documentation that complies with the GAMP V Model. The TEKLYNX design incorporates an easy linking process to your ERP and MRP systems, ensuring that information from production can be delivered to the label at time of print.

ValuTrack Validation Services

As part of the implementation of these applications, customers are required by the FDA to validate the effectiveness and usability of the implemented software within their environment, including operating procedures, etc. using a pre-specified set of Validation Protocols. ValuTrack assists companies with all phases of software validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Talk to a ValuTrack consultant today to learn more about how we can help you meet FDA regulations by calling us at 866.825.8382 or click here to contact us via the web.

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