Strategic IT Services

Our decades of experience in delivering IT compliant solutions to life science companies allows us to customize risk based solutions that are compliant and make business sense. We understand technology, how to test and effectively record its functionality to meet regulatory guidance and guidelines. Our approach is aligned to the ISPE’s GAMP5 standards and includes projects such as:

• Document Management System implementations using M365 E5 to ensure security and protection.
• Training Management technologies to track and monitor employee curriculum compliance
• eCRF, eCOA to manage clinical data
• Programmable Logic Controllers and Distributed Control Systems for manufacturing control
• Electronic Signature platforms such as Docusign, Adobe enable paperless performance

We do not believe that GMP equates to Great Mountains of Paper when performing validation of your systems!