ADC Therapeutics Cuts Document Approval Time by 75% with 21 CFR Part 11 eQMS

ADC Therapeutics is a clinical-stage oncology company focused on developing antibody-drug conjugate (ADC) therapies for hematological malignancies and solid tumors. As a highly regulated biopharmaceutical organization preparing for commercial-scale operations, ADC Therapeutics required a robust standard management system that could handle the complexity of their regulatory documentation, SOP lifecycle, and cross-functional approval workflows.

The company partnered with AmpleLogic to implement the Standard Management Module, a component of AmpleLogic's eQMS platform. The solution automated the complete lifecycle of controlled documents — from authoring and multi-level review through approval, distribution, and periodic review. Configurable workflows ensured the right stakeholders were notified at each stage, while built-in electronic signatures met 21 CFR Part 11 and EU Annex 11 requirements.

Beyond document control, the platform provided comprehensive change management capabilities, linking standard operating procedures directly to training assignments. When a document was updated and approved, the system automatically triggered training notifications to all affected personnel, ensuring that no one operated under an outdated procedure.

The impact was immediate and measurable: document approval cycle times decreased by 75%, training assignment accuracy improved significantly, and the quality team gained full visibility into document status across the organization. With AmpleLogic, ADC Therapeutics established a scalable quality infrastructure ready to support commercial launch and regulatory submissions.