ComplianceAuthorTM | Automation for end-to-end regulated content management

ComplianceAuthor is a quality critical system for Clinical Trial Supply labeling solution that manages study information, country regulations, as well as translations to define, control and approve clinical label content. It ensures your data is reliable, complete, consistent, accurate, and secure throughout the entire lifecycle. Customers report the following benefits:

Reduce label creation time from 4 weeks to 4 days

ComplianceAuthor introduces workflow-driven automation that alleviates the headache and workload associated with manual interpretation, translation, and content management. Instead it easily defines, populates, and manages study information and enforces regulatory requirements for compliant label content. Customers report dramatic time savings in their end-to-end processes: reduced Label Definition Contract (LDC) and single panel/booklet label creation times and faster approval efforts.

Transition from error-prone processes and manual interpretation

Non-compliant labeling leads to invalidated studies, product recalls costing millions, adverse patient impacts, missed first-to-file advantages, and reputation damage. Manual processes for record maintenance, change notifications, and interpretation of complex regulatory requirements lack verification and pose high risk for these outcomes. Instead, our validated engine boasts 13,000 business rules configured with logic and factoring variability to replace high risk manual processes.

Enforce operational compliance and data integrity

ComplianceAuthor ensures that your data not only meets regulatory requirements but that it is reliable, complete, consistent, accurate and secure throughout the data lifecycle. A validated electronic alternative to paper-based processes—printed copies and wet signatures—ComplianceAuthor reduces data variability and has full indexed search capability. Furthermore, it directly links phrases and translations with an automated translation service for back translation and verification.

Gain confidence demonstrating control during audits

Users follow a simple workflow with audit history for electronic approval of master labels and all required source documents are linked to the final label. Built-in system change control makes it possible to easily search all change requests and enforces compliance for all documents. Advanced search capabilities provide rapid access to all data, meta-data, and document types yielding excellent traceability. No more wet signatures, printed approvals stored in folders, or misplaced documents.