How To Reduce Compliance Risk for Pharmaceutical and Medical Device Companies

The source datasets are often complex, semi-structured and un-linked to key entities. With GoodData, all of these datasets are unified to serve as a central semantic data model layer, building into a galaxy schema with dimensions, bridge, and facts, which then forms the backbone that powers the [...] data intelligence cloud. Building insights and dashboards become a much easier task once the underlying data model is designed. GoodData enforces certain best practices as a BI tool, which must be adhered to get the true value of the raw data. For e.g. the source FDA dashboard may just show inspection data but the Site Profile dashboard built on GoodData goes beyond the standard information and shows more insight into site risk scores and can be drilled into details. There is blog written on this topic: [...].

GoodData provides a rich collection of visualization options that help us create compelling story-telling via dashboards. Being well-prepared for FDA inspections is essential for maintaining product quality, regulatory compliance, and avoiding serious business setbacks. FDA inspections are critical events that can shape a company’s market access and reputation. The FDA itself offers the FDA Data Dashboard, but it doesn’t make every document available. There is a blog written on this topic: [...].

Medical devices and technologies do not stop evolving after they receive regulatory approval. Once a product hits the market, it faces real-world usage, compliance challenges, and an array of regulatory scrutiny. Managing these postmarket dynamics is critical to a product’s long-term success and patient safety. However, many companies struggle to keep track of relevant events across a product’s markets, from adverse event reports to changing regulations. Postmarket Intelligence developed on GoodData platform enables us to solve that problem. It empowers MedTech companies to efficiently monitor, assess, and act on postmarket data—saving time, improving decision-making, and ensuring compliance with industry standards. Anyone who is used to trying to get the data they need from the various FDA, and other regulatory agency websites, knows that collecting, cleaning, and structuring that data takes hours. And that’s before any analysis can get done. We enable customers to free up time to focus only on the high-value analysis and subsequent recommendations to leadership, rather than wrangling the data.

The data pipeline refresh that is provided by GoodData Platform is also quite useful from data engineering perspective. The Automated Data Distribution v2 or commonly called as ADD refresh follows a set pattern of identifying the analytical data model through output stage which helps abstract the complex table definition to simpler views that can help with quick rebuild at the data warehouse level while loading the data into GoodData's ADS storage layer. The import first way of loading data into GoodData's cloud storage, followed by querying for any aggregations or metrics on the GoodData analyzer, makes this simple and fast.

GoodData's latest product i.e. Cloud also offers several good features like Analytics as Code which helps software engineering teams follow a code-first approach to analytics, where building insights, dashboards or even datasets can be done in YAML templates or serviced by REST APIs. This is particularly forward thinking in the modern technology stack and evolving industry requirements. These provide seamless integration options to front-end and backend code, embedded analytics with multiple choices from HTML to React based workloads. At [...], we are currently exploring most of these features while planning for a future migration from Platform to Cloud.