Cloud computing: A smart move for FDA-regulated businesses?
As recent as five years ago, biotech and pharmaceutical companies were apprehensive about operating FDA-regulated business applications - like finance and operations - in the cloud. The concept of SAAS ERP was not only daunting, but it also raised...
5 Considerations for Getting to a Validated, Cloud-based ERP Solution
If you produce products in pharmaceuticals, nutraceuticals, or biotechnology, your organization must maintain system validation. The FDA defines this as “establishing documented evidence that provides a high degree of assurance that a...
Digital marketplace for novel suppliers of PPE
HealthEquip, the leading app to speed donated PPE to healthcare organizations, now enables the procurement of PPE from trusted sources in the HealthEquip marketplace. This marketplace is the first of its kind to provide seller storefronts, managed...
Top Five Features to Look for in an ERP for Life Sciences
This industry is broad and unique in many ways, mainly because it “develops” as companies go through the life cycle from pre-clinical phases to the approval or market phase. There are distinct requirements at each phase of the life cycle. Here are...
21 CFR Part 11 Compliance: What You Need to Know
In 1997, the FDA enacted regulation 21 CFR Part 11, which outlines how FDA regulated industries must handle electronic signatures and electronic records. This regulation sets the standards that must be met by pharmaceutical, medical device, and...
Top 8 Pitfalls and Challenges of CAPA Systems and Processes
Pharmaceutical, Medical Device, and BioTech companies are required to detect and react to non-conformances and ensure that appropriate actions are taken to correct and prevent future occurrences. Still, more than half of the FDA Form 483...