With increase in global and domestic competition and product patent in
place, biotech and pharma companies have to improve their operational efficiency
by adopting Sales Force Automation (SFA), an important business application and
need adequate controls. Similarly R&D and clinical trials processes that
have been technology enabled have to be secured to protect the intellectual
property. Now the life sciences business is less about pills and potions and
more about information. The new and direct role of IT is to turn intellectual
assets to cash. So there is a need for multilevel collaboration between life
sciences companies and IT vendors. This kind of partnership will help to address
the future issues such as changing business models, new information
dependencies, compliance and regulatory issues and shorter time to market felt
the Chief Information Officers (CIOs) of leading biopharma and pharma companies
at a panel discussion conducted RSA Security in Mumbai in association with
Dataquest, a leading IT magazine, where BioSpectrum was knowledge partner for
this seminar. RSA Security provides such solutions that address the central
requirements of 21 CFR Part 11 like authentication, data integrity,
confidentiality, audit trials, non repudiation, access control, unique
electronic signatures that identify an individual. Addressing the delegates Ross
Wilson of RSA Security said, "21 CFR Part 11 requires procedural controls
(notification, training, SOPs, administration) and administrative controls to be
put in place by the user in addition to the technical controls."