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