Products 21 CFR Part 11 Compliance Software

21 CFR Part 11 Compliance Software

21 CFR Part 11 Compliance Software

Become FDA Part 11 Compliant with ValuTrack and TEKLYNX

TEKLYNX Life Sciences is an integrated Label Management and Inventory Control FDA Compliance Management System designed to specifically address the needs of the Life Sciences industry, and exceeds 21 CFR part 11 compliance. TEKLYNX Life Sciences is a validated labeling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model.

TEKLYNX Life Sciences is an off-the-shelf solution that enables you to implement a single complete solution to meet all your labeling processes within your organization. Learn more by scrolling over the integrated modules below.

The TEKLYNX design incorporates an easy linking process to your ERP and MRP systems delivering critical production information to your label printers when and where you need it.

Validation Services

As part of the implementation of software applications and hardware devices the FDA requires that your integrated system meets it's intended use.  

ValuTrack assists companies with all phases of validation, including:

  • IQ/OQ/PQ
  • Functionality
  • Safety
  • Reliability
  • Compliance 

Talk to a ValuTrack consultant today to learn more about how ValuTrack 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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