Published: April 06, 2011
New TEKLYNX CENTRAL CFR Enterprise Software Provides Comprehensive Life Sciences Labeling Solution for Data Security and Regulatory Compliance
MILWAUKEE - (BUSINESS WIRE) - 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.

Primum
Colin Hutt, 414-765-2311
colin@primumagency.com
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