Experts Tell Pharma: Tear Down Those Data Silos

It is often said the pharma industry has lagged behind others in converting from paper-based recordkeeping, notably in clinical trials, to an all-electronic environment.

The best approach to making the conversion is to implement companywide standards to combat the “silo” approach to data management, said several speakers at the Interphex conference in March.

This kind of compartmentalization can spell big regulatory trouble, because “you don’t have visibility across [departments], but the FDA has visibility across and will audit you,” said Dennis Constantinou, industry director for life sciences strategy and marketing at Oracle. “You have quality control, manufacturing and compliance officers who do not know each other,” he added.

IT builds quality into the process, Constantinou said. “With workflow management, you are automating compliance requirements throughout the process, providing information to the business managers to enable them to make decisions,” he said. This helps create audit trails, which may be inadequate if all the firm has is paper records. The goal is to create what Constantinou calls a “single source of truth,” the opposite of the silo approach.

Similarly, the best way to mitigate risk in automation is “by using global standards,” said Steve Murray of Emerson Process Management. This can be accomplished by a modular approach involving either an end user-maintained library or a vendor-supplied code library, he said.

Nagesh Nama of Valimation also stressed the importance of applying uniform standards, specifically when it comes to network qualification. “The most important thing to keep in mind is standardization; for instance, of routers, switches and firewalls … otherwise it’s a waste of time,” he stressed.

Oracle has a range of applications for clinical data management, clinical trial management and electronic data capture (EDC), Constantinou said. Examples include Oracle’s ERES (electronic records and electronic signatures) package for compliance with Part 11, and iLearning for training employees in compliance regulations.

Oracle has been developing products for the pharma industry for about 15 years and offers “complete supply chain management,” warehouse management and distribution, and clinical applications, according to Constantinou. The company’s process manufacturing operations have been available in their current form for about five to seven years and its EDC offerings for about three years, he said.

Standardization and an end to data-system compartmentalization can make the manufacturing process more efficient, said Constantinou. In the past, FDA regulations inhibited change because the agency had to revalidate any overhauled system, he said. The electronic compliance framework Oracle offers is designed to “provide enterprise-wide visibility” in compliance with FDA safety and “good x practices” (GxP) regulations (which include good laboratory practices, good manufacturing practices and good clinical practices). The framework is built from Part 11-compliant transactional records, he said. — Martin Gidron