21 CFR PART 11 COMPLIANT LABEL SOFTWARE
TEKLYNX CENTRAL CFR combines the proven technology of TEKLYNX label design, printing, and tracking software into a single regulatory solution that helps your organization fall in line with FDA compliance standards. Our solution offers an integrated label management system designed specifically to address FDA 21 CFR Part 11 as well as your existing predicate requirements.
TEKLYNX CENTRAL CFR helps you address 21 CFR Part 11, FDA regulatory compliance solutions, and other labeling requirements.
- Hosted label printing for supplier networks. By enabling out-of-network printing, local printing features allow you to force suppliers and/or vendors to print your internally approved labels.
- Improve brand awareness internally and externally. Customize the color scheme of your user interface and add your company’s logo to the print page. Whether it’s an internal resource or a vendor printing from your TEKLYNX CENTRAL instance, your branding is carried through.
- Secure Electronic Records, Record Retention, and Retrieval. TEKLYNX CENTRAL CFR creates a centralized server-side activity log.
- Records Audit Trails. TEKLYNX CENTRAL CFR tracks the who, what, where, and when for each print job, including specific variable data for each job. Information is tracked throughout a label’s life cycle, from creation and modification to deletion.
- Electronic Signatures. TEKLYNX CENTRAL CFR regulatory compliance software ensures that electronic signatures are linked to relevant electronic records by requiring User ID and password sign-in to perform all functions.
- Limited Access. TEKLYNX CENTRAL CFR provides authority checks to ensure that only authorized individuals can use the system and/or electronically sign a record. User privileges are controlled by customizable user groups, password expiration, and failed login tracking, all managed with Windows Active Directory.
- Validated Computer Systems. TEKLYNX CENTRAL CFR offers 3 years of support after a major version release, providing a stable system that will avoid the cost and time spent on re-validation.
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