Electronic Labeling Software enables (CFR) 21 Part 11 compliance.July 8, 2011 -
With TEKLYNX CENTRAL CFR, life sciences companies can achieve compliance with CFR 21 Part 11. Program enables auditable tracking of user activity across label design, printing, security, and tracing applications. In addition to security measures, software focuses on product safety by helping companies properly identify their products and communicate important information to end user. Label designer can pull information from text files or databases as well as create complex bar codes.
Original Press release
Teklynx
409 E. Silver Spring Dr., Suite U12
Whitefish Bay, WI, 53217
USA
New Teklynx Central CFR Enterprise Software Provides Comprehensive Life Sciences Labeling Solution for Data Security and Regulatory Compliance
MILWAUKEE -- TEKLYNX, the world's leading developer of automatic identification and
data collection (AIDC) software, has launched TEKLYNX CENTRAL CFR, an enterprise-class
electronic labeling software solution to help life sciences companies achieve compliance with Code of Federal Regulations (CFR) 21 Part 11.
The newest TEKLYNX innovation enables auditable tracking of user activity across TEKLYNX' proven label design, printing, security and tracing applications. In addition to industry-leading security measures, TEKLYNX CENTRAL CFR focuses on product safety by helping companies properly identify their products and communicate important information to the end user.
With one central command center, TEKLYNX CENTRAL CFR helps organizations cut costs, improve efficiency and increase productivity. The life sciences-focused product is based on the widely used TEKLYNX enterprise software: CODESOFT, SENTINEL, and LABEL ARCHIVE, equipping the CFR solution with proven features and stability. The platform has an unsurpassed level of configuration options, compatible printers and drivers.
"TEKLYNX CENTRAL CFR is tailored top-to-bottom for life sciences companies to make it easy for them to meet federal labeling regulations," said Laura Henderson, Managing Director of TEKLYNX Americas. "The idea for this product really came from our life sciences customers who have been excited about the proven TEKLYNX technology, but asking for a focused solution just for them."
The TEKLYNX CENTRAL CFR label designer can pull information from text files or databases. It also creates complex bar codes, including HIBC or GS1 Databar.
The software has been subject to a strictly controlled development process consistent with international standards for the software development lifecycle and validation. The rigorous process ensures the software consistently and reliably meets functional requirements while ensuring safety through verification and traceability. These design controls are specifically aimed at helping companies satisfy regulatory requirements that will lead to a fully validated Commercially Available Off-the-Shelf
(COTS) system once implemented for its intended use.
"TEKLYNX CENTRAL CFR has been leveraged from a solid application platform and wrapped with functionality to provide seamless integration into the entire regulated enterprise," said Tony Raymond, industry consultant and President of New Harbor SQA. "Pharmaceutical companies, high-volume laboratories and other organizations that require a robust Quality Management System will find that Validation of this new product in their end-user environment is extremely straight forward."
TEKLYNX CENTRAL CFR is available through the TEKLYNX network of 1,500 resellers and
integrators around the world.
TEKLYNX International is the leading software developer of AIDC products including software for label design, host connectivity, and data collection. Its software products feature the widest range of device and driver support in the industry. TEKLYNX is a Microsoft Gold Certified Partner, Oracle Gold Partner and has connectivity relationships with multiple Enterprise Resource Planning (ERP) software
providers. More than 600,000 companies in 120 countries rely on its integrated software solutions for supply chain automation, warehouse management, shipping and receiving, inventory control and asset management. The company is headquartered in Milwaukee with operations in the United States, Europe, Japan, China, and Singapore.
More information on TEKLYNX International is available at www.teklynx.com.
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