TEKLYNX CENTRAL CFR

Centralized Label Management

TEKLYNX CENTRAL CFR is an enterprise label management and inventory control system designed specifically to address FDA 21 CFR Part 11 labeling requirements. TEKLYNX CENTRAL CFR offers coordinated licensing for all of your TEKLYNX applications and allows administration of all users across the organization from a single source.

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 includes:

• A label designer that can pull information from your existing systems.
• A label approval module that offers up to three tiers of authorization and central label file storage.
• An automated network printing module that can manage hundreds of printers in multiple locations from a single server.
• Custom reporting options that provide complete document history and activity logs.
• A browser-based user interface for business logic driven label selection and printing.
• A mobile app that allows you to print from your iOS or Android device.

Achieve 21 CFR Part 1 Compliance With a Single Solution

Here’s how TEKLYNX CENTRAL CFR helps you address 21 CFR Part 11 labeling requirements:

• Electronic Records, Retention, and Retrieval. TEKLYNX CENTRAL CFR creates a centralized server-side activity log to provide complete traceability and accessibility when you need it.
• Records Audit Trails. The system tracks the who, what, where, and when for each print job, including specific variable data for each job. With information being tracked throughout a label’s life cycle, from creation and modification to deletion, you are always prepared for an audit.
• Electronic Signatures. A User ID and password sign-in is required to design or print labels, ensuring electronic signatures are linked to the relevant electronic records.
• Limited Access. User privileges are controlled with customizable user groups so only authorized individuals can use the system and/or electronically sign a record. For added security, user’s passwords expire and any failed login attempts are tracked using Windows Active Directory.
• Validated Computer System. TEKLYNX CENTRAL CFR is part of a Validated Computer System when installed and configured in accordance with FDA guidelines.

Is TEKLYNX CENTRAL CFR your solution?

Often, the need for a single, unified solution to handle label design, approval, printing, and reporting arises when organizations in industries such as healthcare, life sciences, and pharmaceutical, need to comply with regulatory requirements such as FDA 21 CFR Part 11. With the ability to manage supply chain labeling and integrate with ERP and other business systems, TEKLYNX CENTRAL CFR helps you increase operational efficiency.

Companies who use TEKLYNX CENTRAL CFR typically have:

• Over 10 printers
• Significant number of users
• Multiple production lines and locations
• Third-party suppliers who print their labels
• Lean manufacturing initiatives
• Compliance regulations
• Business system integration