TEKLYNX CENTRAL CFR Enterprise Software
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.
Achieve 21 CFR Part 11 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.