Skyland Analytics' Latest Risk Management Services Caters Life Science Manufacturers
FREMONT, CA: Skyland Analytics has introduced new Risk Management Services targeted specifically towards Life Science manufacturers. The new services are offered to manage risks raised due to recent trends such as greater manufacturing complexity, explosive growth in contract manufacturing and increased scrutiny into manufacturing operations by the Food and Drug Administration (FDA) and the Securities and Exchange Commission (SEC).
“It’s been our experience that many Life Science manufacturers focus on FDA compliance, but are not fully aware of the increased attention the SEC is paying to their space,” says Robert M. Di Scipio, CEO, Skyland Analytics. “The SEC seeks to insure that companies disclose material business risks to investors. Increased complexity in Life Science manufacturing is driving additional risks related to process control, product quality, data visibility, data ownership, intellectual property protection and more. We help clients identify, score, and mitigate these risks,” he adds.
Skyland Analytics’ Manufacturing Risk Assessment (MRA) encompasses in-depth analysis of GxP, product and process performance, IT systems, IP strategy and protection, contracts with external partners, and related risk factors. Skyland’s team of professionals analyzes data from multiple corporate, manufacturing and quality systems to determine the occurrence and cause of the risk.
“Our key people are some of the original developers of ‘Discoverant’, a widely-used informatics solution for Life Science manufacturers,” says Di Scipio. “We deployed it successfully with more than 20 of the world’s top drug and device manufacturers—in both captive and contract manufacturing organizations. We’ve seen first-hand the business and legal risks that can result from outsourcing. These risks can be mitigated with properly structured agreements and informatics systems that ensure process data visibility for the drug owner,” he explains.
Final findings and recommendations from the analysis are presented in the form of risk scorecards. “The goal is making it easier for clients to understand where their strengths and vulnerabilities lie, so they’re better positioned to mitigate risk and optimize operations,” says Di Scipio.