IT Infrastructure – Security – Electronic Documents/Signatures - EDC

SciAn Services has invested in leading-edge technologies and systems to manage the delivery of large volumes of clinical data and deal with its inherent complexities. We have designed our IT systems and associated SOPs to comply with FDA “Guidance for Industry – Computerized Systems Used in Clinical Trials” and FDA 21 CFR Part 11 regulations.

Our IT infrastructure is designed to be scaleable and secure to support our data management and biostatistics services; with a focus on large-scale data management and electronic data capture (EDC) solutions.

Both our EDC solution and our internal IT environment have been designed to meet the regulatory requirements set forth by FDA 21 CFR Part 11. We enforce electronic signatures on all permanent electronic documents. These electronic signatures are further protected/encrypted with digital signatures. In our systems, electronic signatures are considered to be legally binding and equivalent to handwritten signatures.

To ensure the highest level of security and maintain the functionality of EDC, we have designed our multi-layered network with multiple firewalls to mirror those of the banking industry. Our architecture ensures that only fully authenticated users are able to access our internal LAN. Our security protocols begin with controlled access to the premises, workstations and servers; followed by controlled access to the databases and systems over the Internet, intrusion detection, virus scanning at all ports of entry and concludes at document-level access control. Our EDC solution incorporates electronic signatures protected by digital signatures with all electronic documents transferred over the Internet using SSL 128 bit-encryption.

We have developed a comprehensive set of SOPs to address all key aspects of our IT department/network maintenance from backup policy, disaster recovery plans, procurement rules for hardware and 3rd-party software applications, to system and software validation and change control. A separate set of SOPs governs the development and maintenance of our internal applications.

As mandated by our corporate SOPs, our systems and associated SOPs undergo periodic independent 3rd party regulatory-compliance audits to assess compliance with FDA 21 CFR Part 11 and FDA Guidance for Computerized Systems Used in Clinical Trials.