Mar 28 Webinar: ComplianceAuthor™ for Clinical Labeling
Join us on Tuesday, March 28th as we introduce ComplianceAuthor™ for Clinical Labeling.
The webinar, titled “Avoid High Risk, Non-Compliant Label Content”, will be presented by Tammy Feichtel and features a recent customer case study: a leading global healthcare company who leveraged ComplianceAuthor™ to yield profound value and benefits.
The customer determined its manual processes posed high risk for non-compliant clinical labeling content. Non-compliant labeling can lead to invalidated studies, product recalls, adverse patient impacts, missed first-to-file advantages, and reputation damage.
Seeking an automated, validated alternative to its in-house application the company selected ComplianceAuthor™ to minimize risk, exceed regulatory expectations and gain confidence demonstrating control during audits.
This webinar will describe the challenges faced with its manual system, the ComplianceAuthor™ solution, and resulting benefits, including:
- Challenge: Bespoke in-house application relies on manual record maintenance, change notifications, and interpretation of complex regulatory requirements; lacks verification and is error-prone.
- Solution: Transition from paper-based processes to automated regulated content management system that enforces business rules yielding compliant phrases, translations and label content.
- Benefits: ComplianceAuthor® enforces operational compliance and data integrity. Data is reliable, complete, consistent, accurate, and secure throughout its lifecycle. Workload and rework costs were reduced by 15 GMP deviations annually and label creation time cut from 4 weeks to 4 days.