. (NASDAQ:QADA) (NASDAQ:QADB), a leading provider of
enterprise software and services
, today announced the enhanced traceability framework in
QAD Enterprise Applications
supports evolving regulatory requirements for
Unique Device Identification
rely on QAD Enterprise Applications to optimize quality control throughout their manufacturing and distribution
The QAD traceability framework equips
medical device customers
with the tools to manage
across their global healthcare supply chain — from component to product to patient. “QAD customers can accurately track, trace and identify the components and resources — including the items, parts, machines and labor — involved in their manufacturing processes,” said Dave Medina, vice president of Life Sciences at QAD. “With QAD’s enhanced traceability framework, medical device makers capture real time data to meet the regulatory requirements of UDI.”
QAD Enterprise Applications
Tailored to Simplify the Burden of Regulatory Compliance
QAD Enterprise Applications supports manufacturers in achieving regulatory compliance and validation against Current Good Manufacturing Practices (cGMP). In addition QAD supports the upcoming regulations from the United States Food and Drug Administration Amendments
(FDAAA) for UDI. The law requires manufacturers to label their devices — products ranging from MRI equipment to orthopedics to lab tests and rubber gloves — with a unique identifier to track and trace a product by lot or serial number.
, tailored to simplify the burden of regulatory compliance, allow manufacturers to prepare for similar UDI standards under discussion by the European Commission (
), the International Medical Device Regulators Forum (
) and other global agencies. These mandates are all concerned with better managing product traceability, especially post-market safety surveillance, recall management and safety alerts. QAD Enterprise Applications makes it simpler for medical device makers to achieve regulatory compliance and ensure product integrity.
Enhanced Traceability in QAD Enterprise Applications Supports Patient Safety
Patient safety is of critical concern for medical device manufacturers. In the case of an adverse event that leads to a product recall, QAD Enterprise Applications enables customers to efficiently manage and evaluate the effectiveness of a recall. It allows customers to trace a recalled item back to its original manufacturing
batch or lot
and then forward to locate any potentially affected finished product that is still in inventory or in the supply chain.
Medical device manufacturers are able to better manage quality issues including product complaints, non-conformance reporting (NCRs), audits and CAPAs with QAD Enterprise Applications.