How Cloud-Based Tools Can Help With FDA Compliance

These days, enforcing FDA compliance and mentoring new team members are more challenging than ever, thanks to a workforce that is more remote, international, and diverse. Additionally, today’s Internet technology is more global, sophisticated, and secure. With these changes, pharmaceutical companies need to adapt to grow and ride the cost-conscious trend just to survive. Cloud-based tools, such as wikis, offer a paradigm shift in project management, FDA compliance requirements, and job aids for mentoring new employees.

With the lack of face-to-face interactions, more emphasis is placed on Internet technology to help automate and standardize repetitive tasks. For example, project management tools, such as Projecis, capture and communicate important milestones and deliverable details. By using a cloud-based project management application, that important data is always available and automatically backed up. It’s those types of benefits that often empower small biotech companies, for example, to outsource their IT infrastructure to gain powerful computing platforms at a minimum cost. As an extension, some vendors also offer cloud-based EDC systems to help automate the collection and “cleaning” of clinical data. In the pharmaceutical industry, practical applications of project management tools include tracking clinical data issues or issues related to validating datasets or summary tables.