The Challenge of FDA Regulation
The Life Science and Medical device sector is challenged by increasing pressure to deliver cost-effective and efficient healthcare services and products that meet the stringent requirements of global regulatory agencies such as the Food and Drug Administration (FDA).
When implementing a design control process, this can turn out to be a very comprehensive project. Not only are you defining the process, but you’re also adopting new technology to manage the process. The good news is that the FDA does not enforce specific rules or circumstances for implementing a design control process. They do provide a general framework that helps guide an organization to define a process that meets the FDA regulations as well as meet their own quality standards.
Where Does Team Foundation Server (TFS) 2015 Play a Part in This?
TFS is an Application Lifecycle Management (ALM) tool that has been used for software development projects. Over the last couple of years, we are seeing more and more companies adopt TFS to manage complex software and hardware projects, and we are asked by our clients about executing the validation process and electronic signatures for the use of TFS in a regulatory production environment. To learn more of what we’ve done and view some of our guidelines, read our blog on Validating TFS in a Regulated Environment.
Let InCycle Be Your Guide
As ALM experts we are well versed in how to best customize TFS for your regulated environment. In addition, we can lead the validation effort and train your users on the Standard Operating Procedure (SOP) and industry specific best practices.
To contact one of our consultants call (800) 565-0510 or you can also fill out the form below. We look forward to hearing from you!