GxP Technologies

An intelligent, fully validated, GxP process automation platform built on ServiceNow

Efficient ways to address events that have regulatory implications.

Every day, life sciences companies must deal with various events having regulatory implications and find the most efficient way to resolve them. Processes and data are often stored and managed in disparate systems and attempts at process automation often leave out intelligent or real-time insight that would bring about the desired business outcomes. Time-consuming, fragmented processes create product delays, increase regulatory risk, and result in poor business performance.

Imagine a platform that enables process automation and quality by design – while simplifying, scaling, and maintaining regulatory compliance.

Introducing ProcessX

Today, product innovation is possible with the convergence of modern cloud technologies, low/no code development platforms, and artificial intelligence (AI). ProcessX is an intelligent, fully validated, GxP process automation platform built on the ServiceNow technology stack. It simplifies regulated workflows and processes to drive greater efficiency and insight across your organization—ultimately contributing to product quality and patient safety. With automated compliance and AI capabilities, Quality and IT leaders gain greater insight into the entire product lifecycle and supply chain and minimize costly recalls or undetected systemic issues.

SUPPORTED REGULATIONS

21 CFR Part 11
FDA GxP
FDA cGMP
ISO 9000
ISO 13485
ISO 14000
ISO 27000
AS9100
IATF 16949
ITIL
Sarbanes-Oxley
and more

Request A Demo

Request a general ProcessX demo for your team. Or tell us about your manual workflow and we will customize a demo for your specific need.

Solutions to address the most critical GxP areas of your business.

Regulated IT Workflows

Controlling GxP data is a challenge – often leading to fragmented or duplicative IT systems, increased IT expenses and overhead, and lots of operational inefficiencies.

Expanding ServiceNow to include GxP IT workflows with ProcessX leverages your existing system, control costs, and enables controlled GxP system inventory in a few clicks.

GxP Workflows:

  • GxP Incident Management (ITSM)
  • Cybersecurity Incident (ITSM)
  • GxP Change Management (ITSM)
  • Regulatory Applicability Assessment (CMDB)
  • Periodic Review
  • User Access Provisioning

Manufacturing Workflows

Manufacturing plants are still largely paper-based. GxP systems like MES and LIMS help automate processes, but there are still manual processes that cause GDP errors, lengthy deviations, and CAPAs.

Regulated processes like Logbooks, can be built and deployed quickly using a familiar technology. ProcessX takes the ServiceNow platform, makes it 21 CFR Part 11 / Annex 11 compliant, and maintains compliance. 

GxP Workflows:

  • Logbooks
  • Paperless Manufacturing
  • Send us your paper-based workflow, and we’ll automate it for you!

Adverse Event Workflows

AE case volume is overwhelming and unmanageable. Multiple intake channels and multiple languages, require many people to transcribe (and translate) to legacy safety systems. 

ProcessX automates AE intake from many sources using language support to ingest data and streamlines triaging data with AI to simplify event management and ensure safety teams are utilized in a more efficient manner.

GxP Workflows:

  • Adverse Event Intake
  • Adverse Event Triage
  • Integrated into your existing PMS or complaints-handling systems

ProcessX can automate any manual GxP process and delivers up to 5x speed and efficiency.

ProcessX Advantage

Flexible Platform | Automate GxP processes in clicks

Workflows are easily added and automated using rule-based decision-making to dynamically select tasks, assign team members, and create a checklist to streamline and optimize workflow routing and execution. No code changes. No guesswork. No human error.

Automated Processes | Get quality by design with compliance built-in

Designed from 20+ years of life sciences business process and regulatory compliance expertise, ProcessX includes 21 CFR Part 11 eSignatures and audit trails. It automates and maintains validation and testing with a USDM Cloud AssuranceTM subscription—regulation is no longer a barrier to innovation.

Accelerated Performance | Experience enterprise-wide efficiencies

Rapidly implement new workflows and gain valuable insight from your processes and data to drive better business decisions. ServiceNow’s open APIs enable robust integrations with various collaboration tools and other enterprise systems you are already using.

Affordable Price | Pay a flat licensing fee

You don’t have to increase your IT systems or overhead when you leverage your existing investment in ServiceNow. The flat licensing fee helps you control IT costs and ensures access across your organization while scaling your use cases. Pre-built packages with validation and training documentation are available to fast-track your implementation.

ServiceNow Advantage

As a native ServiceNow application, ProcessX has been designed and tested for fast, agile, resilient, secure, human, and connected digital transformation. Benefit from One Platform, One Data Model, and One Architecture with the performance, security, and graphical user interface (GUI) of the ServiceNow technology stack. Now your GxP and non-GxP processes can be harmonized in one platform.

ProcessX takes the NOW platform, makes it 21 CFR Part 11 compliant, and enables citizen development without coding. Easy to develop, easy to maintain, and fully (and continuously) validated.

Watch the on-demand webinar below to learn more.

Download the ProcessX Master Service Agreement.

Contact us today to schedule a demo.

Related Services

USDM Cloud Assurance

USDM Cloud Assurance is a managed service that offloads your vendor release management and maintenance of ongoing system updates, patches, and changes.

GxP Cloud Platforms

Your success depends on harnessing cloud technology to enable your teams to work from anywhere, build platforms that differentiate your company, and innovate faster. 

AI and ML in Life Sciences

USDM has solutions for the GxP challenges you face when adopting automated solutions like machine learning, artificial intelligence, and automated testing.

Resources that might interest you

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