Document Management
"You don't store your money in a mattress and you should not store your data in a filing cabinet." The Health Authorities have moved to an electronic environment to increase their efficiencies but the Sponsor has the drug in development longer than the Agency has it under review. Therefore the benefits of an electronic environment are a greater value the sooner they are implemented.
Your key asset is the data that are reflected in the technical documents. These must be stored in a secure environment, change controlled and made accessible to the people that need the information to move the business forward.
Electronic Infrastructure
The establishment of an electronic infrastructure to manage regulatory documentation is prohibitive in terms of costs and time to establish and validate the system, for the small company, but at the same time it is essential. We offer a solution to this dilemma. We have established an electronic infrastructure that is based on the industry standards. It utilizes Documentum®, Dossier Publishing, Citrix and Exchange servers.
External access is controlled through a perimeter router and firewall using the highest levels of security and encryption. The real world and internal network are separated by a DMZ that houses the VPN endpoints and Remote Access Solution for employees and clients. Connections from the DMZ to the internal network are monitored by a second dedicated firewall.
The internal network is built on a Microsoft Windows 2003 Active Directory platform. Servers utilize dedicated Gigabit connection optimal access. The Microsoft environment, including mail, handled by Exchange 2003 platform, has been inspected by two independent certified engineers and validated as compliant with both industry and Microsoft 'best practice' compliant for desk implementation and security. All systems are backed up to tape each evening. Tapes are stored offsite through a dedicated third party service.
A multi-server redundant back up and high-speed scanning and software [standard and custom] complement our template database and document management systems.
Publishing
NDA filing must begin early to ensure a well organized and cogent document.
The FDA has clearly stated that they are moving to the Common Technical Document [CTD] Format for filing of new drug applications. We provide templates that implement the requirements of the CTD and can publish the submission in electronic or paper format. While there are vendors that can publish your document, they are IT based and not regulatory strategist. The NDA is a regulatory strategic document that requires knowledge IT staff to implement. The content of the document and the appropriate linking is the key to timely approval, not the format. The FDA refuses to file approximately 11% of the applications it receives and this is devastating, and can be fatal to a small organization.