We frequently blog about FDA Warning Letters and other regulatory and compliance issues that revolve around traditional pharmaceuticals and medical devices. However, one product segment that we haven’t yet discussed is digital health. This is because digital health products are fairly new to the market and most are still trying to figure out how FDA […]
Posts Tagged ‘Regulatory Compliance’
When The FDA Is Concerned About Your Ability To Monitor Drugs
A couple of weeks ago, I wrote about a warning letter that was issued to a pharmaceutical company last month. I highlighted one of the FDA’s findings, which had to do with the company’s standard operating procedures (SOPs) having an insufficient amount of detail about their process for collecting adverse events. Today, I want […]
Information Lifecycle Management, the ignored EIM component
One of the less addressed areas of Enterprise Information Management (EIM) is the Information Life cycle Management (ILM). If you think about it Life cycle management touches key business areas especially regulated industries like financial services. IT is concerned with managing storage, application performance issues due to large volumes of accumulated historical data and the […]