Since 2013 when signed into law, the Drug Quality and Security Act (DQSA) has slowly introduced new guidelines that will run through 2023. Title II, specifically the Drug Supply Chain Security Act (DSCSA), details specific electronic and business systems measures to trace and identify the distribution of prescription drugs throughout the US. The basic premise is the management, traceability and accessibility to lot information in an effort to verify, detect, notify, and facilitate recalls throughout the supply chain. The FDA has been tasked to provide compliance standards and oversight of the Acts with the ultimate goal to protect consumers.
Key provisions will improve the following aspects of product management including:
How does Sage X3 help pharmaceutical manufacturers and distributors meet the new compliance standards?
Sage X3 was designed with process manufacturers in mind. Several capabilities are delivered as standard functionality to meet the demanding - and evolving - FDA compliance requirements. The following features help pharma companies meet the current and planned standards.
1) Lot Traceability to track inventory activity from origin to destination at transaction and historical.
2) Electronic signatures for approval, sign-off and assignability with full audit controls.
3) Formula management with drug potency properties
4) Mobile access and web-based forms that can be published for external customers and vendors to access critical information on-demand.
5) Ability to design and print labels with packaging information
6) Change Control Management for version and revision control plus analytical reporting.