eResearch Technology streamlines compliant records management with Alfresco.
 
A global provider of health outcomes research services, eResearch Technology (ERT) supports biopharmaceutical sponsors, contract research organisations, medical device manufacturers and healthcare organisations around the globe achieve their drug development and healthcare objectives.
Results
  • A standardised platform for the collaborative exchange of digitally signed documents among staff, partners and customers
  • Secure central repository for over 400,000 documents relating to clinical studies, with full traceability of record modifications, versions and all user actions
  • Introduction of digital signature approvals and verification that meets stringent life sciences industry regulatory requirements, including FDA 21 CFR Part 11.
  • Fully electronic workflows have streamlined business processes, enhanced productivity and delivered faster decision - making and approvals while mitigating risk
  • User controls and access rights for defined tasks and individual documents enforces secure records management, process compliance, and accountability to FDA standards
  • Comprehensive audit trail meets stringent regulatory and reporting requirements

Business Challenge

ERT wanted to digitise the creation, management and storage of all client agreements and related documentation, including project approvals and change requests. ERT wanted to move to paperless working, centrally managing and securely storing thousands of documents generated each year relating to its data collection projects around the globe.

“Protecting key assets and compliance with all regulatory requirements was a priority. We needed an ECM solution that could support e-signature authentication, eradicating the risk, time delays and cost involved in printing and dispatching documentation beyond organisational boundaries,”

explains Kurt Palmer, Senior Director, Information Technology at ERT.

 Thanks to Alfresco we’ve been able to eliminate the silos of data that previously existed across our global operations, now, regardless of where they’re located, our staff can instantly access the most current version of documents and instantly retrieve or route documents from our central repository at the press of a button.
Kurt Palmer | Senior Director, Information Technology | ERT
Implementation was undertaken by Zaizi, who developed specially customised workflows and engineered the CoSign integration with Alfresco, combining the two so that workflows for multiple, parallel and sequential signatures can be managed.

Today Alfresco currently manages over 400,000 documents and the process of migrating thousands of legacy documents from Windows file servers continues apace .

Download PDF