Small doesn’t mean less when it comes to life sciences regulatory obligations. Regardless of size, life sciences companies must comply with the same standards, complete the same requirements and capture the same audit trail along the way. The only differences are that at smaller companies these must be accomplished with fewer people, fewer resources, and a smaller budget.
Jason Halpern, Product Manager, CSC Life Sciences
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Regulatory obligations are just a portion of the challenge. Smaller companies are increasingly working with external research or manufacturing partners. As a result, they need a tool that will allow them to collaborate seamlessly, flexibly and efficiently to share information while also protecting their intellectual property.
Few companies have the wherewithal to purchase or build systems with all the bells and whistles of a multi-functional, multi-purpose system. These systems often require the purchase of supporting software and hardware, making the solution an even more expensive proposition.
While there are a number of content management solutions designed for smaller companies, few of these solutions are designed for the life sciences market. As a result, they often lack the best practices and industry expertise to support the specific processes required to meet both business and regulatory needs.
Addressing Specific Needs
Rolling out a brand new system with accompanying hardware and software isn’t always feasible for small companies. They need a tool that can plug into the platforms they already have in place. Most companies – including small companies – already have enterprise-wide Microsoft licenses, which includes SharePoint. As a result, using a SharePoint-based tool often makes sense both economically and from a resource standpoint.
No two companies operate in the same way, especially in a smaller company which may have people assuming multiple roles and therefore may choose to break up responsibilities differently. Companies need the flexibility to be able to assign permissions and capabilities to users so that they can do what the company needs them to do. It’s a delicate balance between flexibility and control, but your solution needs to be able to support your approach and grow with you and your company.
Finally, there’s the question of whether to host a platform internally or have your solution managed on the cloud. For small companies the upfront cost of hosting internally can be a huge hurdle since this will involve allocating precious internal resources, a large up-front cost and subject matter expertise. Companies need to weigh the cost of this approach against the benefits of being fully in control of their environment. However, when managed well, cloud not only removes the infrastructure and resource pain points, but ensures updates are handled, backups are rigorously performed and comprehensive disaster recovery is in place.
As smaller companies consider the options to address their content management needs, it’s important to keep in mind certain key considerations: the need for flexibility, the importance of out-of-the-box industry-specific business processes, the ability to reuse tool that are already in place and the importance of selecting a cloud-based solution.
Learn more about flexible document management and CSC’s new release of FirstPoint.