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As a component of quality assurance, validation is critical. Regulatory authorities like the United States Food & Drug Administration (FDA) and the European Union (EU) have guidelines related to process validation to confirm a company’s labeling processes will result in reliable outputs and meet quality standards.
TEKLYNX VAP templates are in accordance with verification and validation strategies and easily adaptable to specific project requirements. All necessary testing procedures are outlined for ease of completing the installation, operational, and performance qualification documentation that is required for certification.
Save time and resources by accelerating your validation of labeling processes
The TEKLYNX Validation Accelerator Pack (VAP) is available for purchase with CODESOFT + LABEL ARCHIVE or TEKLYNX CENTRAL labeling applications. It is comprised of valuable templates that outline the comprehensive list of necessary acceptance criteria, testing instructions, expected results, and worksheets for documentation of actual results of testing from the validation team.
The TEKLYNX VAP includes the required testing procedures for validation and quality protocols, providing medical device manufacturers and life science companies a tool to simplify and accelerate validation documentation and management:
TEKLYNX recommends you work with our professional services team for label management deployment to help satisfy the documentation needs of IQ, OQ, and PQ validation packages, and to ensure your labeling system aligns with best practices.
FDA 21 CFR Part 11 protects public health and ensures accuracy of electronic medical records
We're here to help you with validation documentation. Complete the short form to request a price quote, and a TEKLYNX labeling expert will reach out to you.
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