Life Sciences

The Microsoft Cloud for Biotech and Pharma Manufacturers Just Got Better

by | Jul 16, 2021 | , , , , ,

Merit for Life Science just became more powerful because Microsoft today announced a new level of integration coming between Dynamics 365 (D365) and Teams. This includes Teams integration with Dynamics 365 sales, marketing, customer service, and field service workloads with operations to follow. Microsoft is essentially saying, “Use Teams as your front-end app for work, with everything else operating as a context-intelligent side pane within Teams.”  Merit for Life Science advances Microsoft's base business and productivity apps to fit the unique needs of pharma and biotech, so this announcement is especially powerful for our industry and our customers.  Multi-step Processes Get Mainstreamed Why?  In biotech, our customer acquisition process tends to be multi-step,...

read more

For Incident Management, Pick Your Course and Complete It

by | Jun 8, 2021 | ,

Distance runners know that the first objective of a race is to complete it, and the second is to respect the integrity of the course. Then they work backward from those two objectives to prepare for pace, considering variables such as weather, managing for resiliency in training and the race, and heeding other factors. If you think about an incident that you must manage in a life science company the same way, you’ll have a nice model for success with two exceptions. One, unlike the specific starting line for a race, the incident can start from a myriad of places inside or outside of your life science company. Two, the length of the race may be different depending on the nature and severity of the incident. The Unpredictable Incident Starting Line A patient may have a reaction to your...

read more

Low Code/No Code: In Life Sciences, Extend Carefully

by | May 25, 2021 | , , , ,

The old joke is that you can do anything with software if you have enough money. With an army of programmers, it was basically true. But now there is a new way to develop software quickly and with much lower investment: low code/no code programming, a.k.a. codeless app development. Essentially, modern digital platforms have created visual building blocks that can be assembled according to user experiences designed by “citizen developers,” a term coined to describe these non-traditional programmers. Imagine building applications or extending functionality without ever writing a line of code!    Microsoft Azure and Power Platform Tools Microsoft has a deep execution of this development approach in Azure with their Power Platform tools. Canvas apps are "no code," and model-driven...

read more

Is Your Data Estate Maximizing its Property Value?

by | May 18, 2021 | , ,

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 his ferocious Dobermans listened to him. With just the right nod to his dogs, they would viciously attack the perpetrator.  Data as the Foundation of Digital Strategy In the past, executives looked at their IT strategy and their business apps as the ultimate foundational component. The prevailing thinking was, “How do I get all of my data into one place that is secure and enables all the workloads I think I’ll need to execute our strategies?” Increasingly, innovative biotech and pharma business executives are looking at...

read more

5 Considerations for Getting to a Validated, Cloud-based ERP Solution

by | Mar 30, 2021 | ,

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 produce a product that meets its predetermined specifications and other quality attributes.” [General Principles of Software Validation | FDA] According to FDA rules, systems that enable processes that could harm or kill humans if deployed incorrectly must be validated. This impartial review is known as Independent Verification and Validation or IV&V. Validation doesn’t mean that the solution deployed is free from any defects, but it should establish confidence that the solution is tested as reliable in its performance...

read more

21 CFR Part 11 Compliance: What You Need to Know

by | Feb 20, 2020 |

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 wish to use an electronic business management system, like an ERP system, quality management system, and / or a quality document management system. These standards apply to all phases of Life Sciences companies, including research, manufacturing and distribution of products and services. This article covers what you need to know about 21 CFR Part 11 compliance. The FDA holds all life sciences companies and executives accountable to very stringent quality and safety standards. Companies use a mixture of electronic systems...

read more