Life sciences companies are seeking to be more flexible and yet have greater control over how they manage their content and documents. They must juggle demands that appear to be contradictory. Systems and processes should be uniform while at the same time be flexible. Information security is paramount, but companies are relying more and more on collaboration with people from outside of the company.
By Jason Halpern, Product Manager, CSC Life Sciences
How can these seemingly mutually opposed requirements coexist? Companies need solutions that can allow for the right balance of control with flexibility, centralization with collaboration, and simplicity with feature-rich systems.
This forward-thinking response to a changing regulatory and commercial environment might best be summed up by six critical “Cs” required for next-generation document management.
The Critical Elements to Document Management:
Collaboration – Traditionally document collaboration has meant different departments within a company working together to perform their sequential tasks to author and approve a document. In today’s world collaboration means so much more. Teams of individuals work across offices, time zones and borders on everything from simple documents to complex virtual documents. It’s essential to have a platform that allows stakeholders to work together in real time through all phases of a document’s life cycle.
Confidence – All too often systems and processes are built while only considering the needs of “super users” – those who use the system constantly or frequently and therefore understand its finer nuances. While these super users may have more sophisticated requirements and push the system to its limit, it is equally important to consider casual users. Although casual users access the system less frequently, they need to feel comfortable and confident that they can find the information they need and use the system to support their work. If they do not have confidence in their ability to use the system, they will work outside of it and undermine the controls and processes that were put in place to support the business.
Compliance – As digital data management continues to grow and evolve, regulators have imposed tougher standards on capturing data, storing it and auditing changes over time. An electronic data management system can take care of these worries by allowing companies to create highly specific rules for accessing and editing data, all the while capturing a robust audit trail.
Control and Configuration – Very often the process of compiling information and creating the content can be challenging. Good document management means being able to control and configure the way information is managed and accessed, control the process involved in managing documents, and control the audit trail.
Centralization – One of the biggest challenges life sciences companies have confronted is lack of harmonization. Even within the same company – never mind when working with partners – different functions and groups have different ways of doing the same thing. Added to this challenge is the fact that the vast majority of life sciences companies have grown and adapted through acquisition. Each one of those acquired entities will have a different way of working and will store information in different locations and systems. Moving to a centralized repository allows users to work on documents in one place, create the foundation for a knowledge management repository, and control the chaos.
Cloud – Many of the requirements described above can be made more efficient through a more flexible approach that frequently comes with a cloud infrastructure. By providing the opportunity to work more collaboratively with external partners and geographically dispersed offices, companies can allow their employees to work wherever they are and whenever they want, thus speeding up the process of document creation and submission.
Responding to Market Needs
As regulatory demands intensify and the business environment evolves, there is greater need to assist users with flexible, intuitive and collaborative approaches to managing and accessing documents. The next generation of document management will not only respond to current needs but will pre-empt the ever changing regulatory and business environment.
To learn more about it please visit us at the EMC World Event in Las Vegas from May 2 to 5 at CSC Booth #705 where I will be happy to answer any questions about document management, regulatory information management, and provide a demonstration of FirstDoc, FirstPoint and Tracker.