Valutrack and Teklynx have partnered to provide a complete CFR Part 11 bar code labeling solution for Life Sciences companies. 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.
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).
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