Keeping the Enterprise Connected

AssurX Briefing Note

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by the Executive Management team at AssurX.  With over twenty years of experience in the Life-Science industry, AssurX is helping customers ensure compliance, improve quality and manage risks via the AssurX platform for integrated enterprise tracking.  AssurX software solutions are available on-premises, in the cloud or as a hybrid option.  The AssurX platform is architected so that customers who are on-premise, can (at any time) move to a combination hybrid or pure cloud solution.  “Customers may have some applications in the cloud, and some on-premises, depending on their security parameters, but the system is 100% portable,” pointed out Tracy Orlick, Director of Marketing at AssurX.

The AssurX Integrated Enterprise Tracking Platform Source: AssurX

AssurX seeks to deliver complete solutions based on Life-Science industry customer requirements.  “It’s an ever-changing landscape; there are a lot of regulations and there are foundational things that any Life Science company starts on, like change control, CAPA, etc.,” said Stephanie McArdle, VP Product Management – Life Sciences Industry at AssurX.

In addition to offering the core platform and a set of preconfigured solutions, AssurX customers have the ability to make configuration changes based on their unique business requirements or they can build new applications from scratch – all within the platform.   “One of our largest differentiating factors is the ability to configure yourself.  Our offering allows the customers to easily make modifications to pre-configured solutions to accommodate what their business process and their business rules are,” continued McArdle.

Life-Science Product Vision

The vision of AssurX is to offer its customers a value-based enterprise quality management system with capabilities for seamless integration to efficiently execute compliance and regulatory requirements across the product lifecycle.   The AssurX platform aims to specifically support life science customers in their digital transformation journey.  For example, medical device customers with European Medical Device Regulation (EU MDR) in mind.

EU MDR rules require greater product transparency and data traceability.  “At the heart of EU MDR, at least in my perspective, is <the belief> that we have to get back to good configuration management. We need to digitize design controls and get that data from archaic paper and reports… the binders and binders of information as it relates to the 510(k). We need to digitize all of that so that companies can effectively manage their device product life cycle with traceability,” noted McArdle.

AssurX brings the cross-functional landscape together by centralizing the data companies need for EU MDR Unique Device Identifier (UDI) requirements and for reporting capabilities.  “Unlike the FDA UDI, there’s so much more information that goes into the requirements for the vigilance reporting,” stated McArdle.  Within AssurX, customers can integrate with the systems that house UDI data – which can often reside in one, two or three separate systems.  The platform offers a central location that makes populating the Manufacturing Incident Report (MIR) form seamless.  AssurX also has metrics and KPIs that companies can leverage for timely reporting and to conduct a predictive analysis on what they’re reporting and why.

In Axendia’s opinion, compliance is a baseline and quality should be the goal for Life-Science companies. The leadership at AssurX recognizes that from a compliance and quality standpoint, medical device companies often have more steps in the design control process; pharmaceutical companies may have more steps within the life cycle.  The AssurX platform offers visibility into product quality data throughout four key phases:  R&D – Pre-Commercial – Commercial – Post-Market. In the R&D phase, companies can leverage the platform’s ability to manage documents and data related to feasibility studies, reach and design.

AssurX has pre-configured solutions to support non-conformance, risk management and investigations, that are often conducted during the Pre-Commercial phase.  For companies who are in the Commercial phase of product, compliance management with regulators, market launch and expansion are supported.  Finally, in the Post-Market phase, surveillance, all types of incident reporting and post market changes are all managed via the platform.

“For example, counterfeiting or tampering issues need to be tracked but don’t always come through as a Complaint.  Pharmaceutical companies sometimes have these data in separate systems all together and what often happens, is that those issues go unreported to quality because when teams investigate these types of issues, they may determine there is no quality issue – when in fact, it could present itself as a trend that would have pointed to the need to make packaging or labeling improvements,” declared McArdle.

How AssurX Differentiates Itself

The executives at AssurX outlined how the company differentiates itself:

  • On-Premise / Cloud QMS / Hybrid solution
    • Multiple tenancy options for cloud users
  • Portability without any loss to data integrity
  • Truly codeless configuration
    • Eliminates need to hire additional internal staff (developers, IT)
  • Seamless integration and enterprise stability
    • No plug-ins or add-ons with different products; dependable, stable, always-on workhorse
    • Extends ROI through integration with LIMS, MES, PLM, ERP, CRM
  • True product expertise: average experience of technical staff is 10 years
  • Built and managed in-house: zero outsourcing

 In Brief

AssurX has developed a powerful platform to support medical device and pharmaceutical companies in their compliance and digital transformation journeys. Life-Science companies of all sizes are leveraging the platform to centrally manage, monitor and improve their quality and regulatory compliance processes across the enterprise.

AssurX recognizes that the needs of a medical device company are unique and has applications within its QMS specifically for design control, change management and post-market surveillance.  We will continue to monitor the AssurX platform and provide periodic updates.


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