Advancing quality management
Transform medical device quality processes, such as APQP and NPI, supplier quality, CAPA and postmarket surveillance, and recalls, from end to end – with Pega.
“We joined silos across supply chain, engineering, regulatory, commercial, etc. ... with Pega.”
Embed product quality – from concept to launch
New Product Introduction (NPI) and Advanced Product Quality Planning (APQP) are challenging enterprise processes for medical device manufacturers. They’re made even more difficult with ad-hoc methods, constantly changing regulations, and siloed organizations that cannot easily communicate and collaborate across an increasingly complex and globalized supply chain.
The Pega Platform™ Case Management for NPI and APQP delivers a centralized, integrated solution for automating complex tasks across multiple functioning silos, departments, geographies, and enterprises, while promoting transparency and visibility throughout the value stream.
With Pega’s Case Management for NPI and APQP, you can:
- Cut the time and cost of delivering new products
- Enhance productivity and cycle time
- Improve visibility and control over processes
- Reduce IT support costs while increasing business agility
Case Study
GE Healthcare transforms quality with Pega
Learn how GE Healthcare replaced its deeply siloed processes to ensure quality – from first design through product end-of-life.
Case Study
Reinforcing a quality-first mindset
Learn how this top-ranked global automaker built an integrated quality management system – and decreased the time from issue detection to assignment by 40%.
Ensure supplier quality across the entire life cycle
Today more than ever – to meet mission-critical quality management standards – medical device manufacturers must closely monitor and manage their relationships with suppliers.
Legacy systems and procurement processes cannot scale to support the needs of a dynamic, global business – without slowing sourcing speeds and increasing cost and risk.
From pre-production planning and supplier onboarding through quality assurance, quality control, and customer fulfillment, Pega’s low-code platform reduces costs and risk in your operations by enabling:
- Sourcing of compliant suppliers
- Rapid onboarding of new suppliers
- Increased visibility and collaboration across corporate quality, manufacturing locations, production lines, and suppliers
- Better controls over new part introductions
- Earlier detection of non-conformance and faster resolution of product problems
- Data integration across functional systems and process silos
- Closing the loop through supplier recovery
Cut out risk in postmarket surveillance and CAPA
Postmarket Surveillance (PMS) and Corrective & Preventative Action (CAPA) are arguably the most critical processes in medical device manufacturing, yet they’re extremely difficult to manage and fraught with risk. Varying government regulations and reporting requirements create added complexity for global companies. Whether you’re dealing with the FDA, CFDA, or EUMDR, fines for non-compliance can cost manufacturers hundreds of millions of dollars a year, and impact brand perception and customer loyalty.
Decentralized and siloed legacy quality management systems add to the pain of PMS and CAPA – decreasing efficiencies, requiring manual work, and increasing risk across the board.
Pega streamlines and de-risks the PMS and CAPA processes, using case management and automation to capture, review, approve, control, and retrieve closed-loop processes. We provide an audit trail and automated reporting. Our flexible, low-code platform can scale across your entire global organization, allowing for easy customizations as required in market.
Case Study
Maintaining safety across global partnerships
Learn how Pfizer manages PVAs for 5,800 products, and reduced reporting efforts, eliminated manual work, and improved compliance and auditability.
Insights
Managing the full recall life cycle
When it comes to medical device recalls, you can’t afford to get it wrong. Learn how Pega can help you manage all aspects of a product recall.
React swiftly to product recalls
When it comes to medical device recalls, you can’t afford to take chances with patient safety. You must manage the events around each recall swiftly and effectively; existing approaches aren’t enough. They leave disconnects in the process and offer an incomplete view across your business as well as with doctors and patients. This leaves you vulnerable to liabilities, regulatory fines, customer dissatisfaction, and worse.
Pega Recall provides a single place for tracking and managing the life cycle of recall campaigns and compliance programs – all while helping you stay focused on providing the best customer and patient experience possible. Linked to your internal systems and data, Pega Recall manages and tracks notifications, communications, SLAs, escalation, parts planning, and real-time analytics – allowing you to take appropriate action to engage every individual with care and respect, whether your recall affects 20 devices or 20 million.
Pega Recall provides:
- A single approach to tracking and managing each recall case
- An end-to-end campaign
- Real results to ensure healthcare system, physician, and patient satisfaction
- Regulatory compliance reporting
Production and process control – reimagined
Check out the case study
“We’ve been able to centralize the tracking of exchange of adverse events, aggregate reports, and safety signals with our partners in our global group. That was only made possible by having the efficiencies and the automation that the system brought.”
Check out the case study
“We joined silos across supply chain, engineering, regulatory, commercial, etc. ... with Pega.”
Check out the case study
“I had high expectations for Pega, and they have been met.”