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Lessons from 483s: Essential Strategies for Medical Device Manufacturers
See how to streamline CFR Part 820 compliance for medical devices. Merit for Life Science tackles CAPA, complaints & training for smoother FDA inspections.
Is Your Data Estate Maximizing its Property Value?
When I hear biotech and pharma executives talk about their company’s “data estate,” I know the Microsoft and Amazon people have been meeting with them. I also think of the little British man who ran the estate on Magnum PI. His shtick was to be intimidating because...
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 or cloud computing was not only daunting, but it also raised a...
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 specific will consistently...
Digital marketplace for novel suppliers of PPE
Merit Solutions announces the expansion of HealthEquip creating a PPE Marketplace
Top Five Features to Look for in an ERP for Life Sciences
Life Sciences organizations need robust solutions capable of meeting stringent regulatory requirements and a long-term partner to rely on.
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 bio-tech companies that...