CASE: Predictable Compliance Across the Organization
A growing biotech company was getting ready to file an application to bring their drugs to market. They had completed the early stages of development and were close to bringing their product to patients, so their compliance risk was also increasing. They had compliance knowledge but not the right systems to support it. They needed a solid document management system to stay in control across the whole organization.
This biotech company wanted to take advantage of ready-made document management in Cloud, but were not sure what to expect from vendors. They had many unanswered questions: What are the potential problems with different vendors? Who manages the risk? Which questions are important to ask the vendor? How can we be sure that vendors are using best practices?
Epista stepped in with advisory and project services. We facilitated the vendor selection and implementation, drawing from extensive EDMS and ERP experience to help select the best vendor, ask the right questions, and make sure all considerations and potential problems were considered early on. We also supported the project by training employees on the new system and aligning understanding across teams and the vendor.
With Epista's help, this biotech company had the knowledge and resources to confidently move to Cloud. They have an overview for the whole organization, allowing them to adapt the system to changes as new regulations and business changes arise. Their compliance is in control, so they can continue growing and bring their innovative drugs to patients worldwide.
To learn more about how Epista can support your compliance efforts, get in touch. We enjoy sharing our knowledge and are happy to discuss continuously improving regulatory compliance in your company: +45 4825 4500 / [email protected].