RKL eSolutions Blog Trends and Insights

Does Sage X3 Meet DQSA & DSCSA Compliance?

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.

Sage X3 Systems Based Signature Dashboard

Key provisions will improve the following aspects of product management including:

  • Identification, especially via electronic barcodes
  • Traceability of parent/child and origin/destination relationships
  • Verification and clear labeling
  • Detection and response resulting in quarantines and recalls
  • Notification of non-compliance
  • Licensing disclosures
  • Logistics and storage licensing to ensure safe handling

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.

X3 tablet based signature

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.

X3 Mobile Capable

5)      Ability to design and print labels with packaging information

6)      Change Control Management for version and revision control plus analytical reporting.

Tags: Sage X3
Walt Goodfield

Written by Walt Goodfield

Walt is based in Cleveland, OH and has been selling, implementing, and supporting ERP software for over 25 years. Currently, he is the Chief Business Officer at RKL eSolutions, driving revenue growth through customer acquisition and strategic business partner alliances.