21 FFR Part 11 Compliance
Meet your 21 CFR Part 11 and other labeling requirements
The TEKLYNX CENTRAL CFR solution includes:
- A label designer that can easily design a label using information from a text file or database, or create complex bar codes such as HIBC or GS1 Databar to meet current 21 CFR Part 11 compliance requirements.
- A label approval module that allows you to approve label designs using electronic signatures, in accordance with FDA requirements along with other industry mandates that require label security and traceability.
- 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 label selection and true internet printing from anywhere in the world.
- A single Command Center that coordinates your enterprise labeling process.
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CENTRAL CFR Benefits:
- Electronic Records and Retention. TEKLYNX CENTRAL CFR creates a centralized server-side activity log.
- Audit Trails. TEKLYNX CENTRAL CFR tracks, who, what, where, and when for each print job, including specific variable data for each job.
- Electronic Signatures. TEKLYNX CENTRAL CFR requires User ID and password sign-in to design or print labels.
- Limited Access. TEKLYNX CENTRAL CFR controls users privledges with customizable user groups. Using Windows Active Directory, user's passwords will expire and Windows will track any failed login attempts.
- Validated Computer Systems. ValuTrack has the experience necessary to install and configure TEKLYNX CENTRAL CFR in accordance with FDA guidelines. Learn more.
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