The Challenge: Why Regulated Content
Life sciences professionals face progressively complex regulatory environments and require access to regulated and nonregulated content in the pursuit of drug development and innovation. Many life sciences companies use inefficient hybrids of paper and computer-based systems with siloed processes for document and content management. These dated legacy solutions provide a disparate user experience for access, search, and workflow, resulting in low system adoption, increased compliance risks, and other significant challenges that delay trial timelines and time-to-market. Zosano Pharma recognized similar challenges with their legacy solution and sought to adopt a new unified system and process.
“Within this industry, almost everything we do is regulated, so having traceability and an applied process of doing things is very important to us,” said Hayley Lewis, VP of regulatory and compliance at Zosano. Previously, this California-based therapeutics provider utilized a file server system with folders containing PDF documents that needed to be tracked and traced manually. After being rendered from their original Microsoft Word documents into PDF versions, these documents were often unattended and incomplete. Employees found themselves wasting time and energy, manually tracking down documents from various file locations around the building.