Q&A: Simplifying Regulated GxP Business Processes in ServiceNow

The below questions were asked following the webinar introduction of ProcessX, USDM’s new GxP process automation platform built on ServiceNow.

Click here to watch the latest ProcessX on-demand webinar

We already use ServiceNow. Is ProcessX a separate instance or does it sit on top of our existing instance?

ProcessX is a paid application (Built on NOW) and subscription service that sits on top of your existing ServiceNow instance.

I don’t have ServiceNow. Do I have to go to them to get licenses first?

No. ProcessX can be sold as an original equipment manufacturer (OEM) product where a ServiceNow instance is embedded within ProcessX. The licensing cost is different than the store model for OEM, so contact your sales rep for more information.

We use ServiceNow for our IT processes and IT service management. What additional benefits does ProcessX offer?

ProcessX can integrate with your existing IT processes and IT service management to extend them for any GxP related events that might arise from your existing incident, problem, case, or change management processes.

ProcessX offers many other GxP-related processes like user access provisioning, regulatory applicability and Part 11 assessment, cybersecurity incidents, certificate of compliance, logs management, and quality processes.

What are some examples of the “actionable insight” I can expect with my GxP processes and data?

All of the data that you capture in ProcessX is reportable. For example, if you have multiple Events recorded in the system, you can easily find out the product, department, or site that is contributing the most to the event, then focus on that area to create actions to handle the events effectively and efficiently.

ProcessX has a lot of bells and whistles. I have one process I need help with. Can you help with just that one?

Yes. ProcessX can handle one process or multiple processes easily. You can even start with one process and add more processes as needed.

Since all processes built on ProcessX interact with the user in the same way, end-user training is minimal.

Are event tasks easily updated?

Yes. The Task Model Configurator in ProcessX is very flexible and extendable. You can select from common life sciences task design patterns or build new task types to create a sequence of activities to automate your business workflow.

I’m not sure how my event needs to be categorized or processed. Can ProcessX help me decide on the best workflow for the event?

Yes, ProcessX can help. The Intelligent Decision Tree in ProcessX uses rule-based decision making to dynamically select tasks, assign team members, and create a checklist to optimize workflow routing and execution. It helps to take the guesswork out of managing your events and create efficiencies and standardization across your organization.

How does the Predictive Modeling feature work in ProcessX?

The Predictive Modeling feature helps you build a learning model to predict events and outcomes based on parameters relevant to your company and use cases. For example, you can predict systemic issues with a high level of accuracy before they occur by leveraging input parameters like historic pattern, frequency, product type, geographical areas, etc. USDM can help you think through the best approach for your company.

We already use a quality management system (QMS) for our processes and to mitigate risk. What additional benefit does ProcessX provide?

ProcessX is a Built on Now compliant automation platform. Unlike quality management systems with pre-defined sets of GxP processes, ProcessX can help you automate any paper process or workflow you have in your organization for GxP or non-GxP use. It is flexible for your use cases and provides a platform for automation and continuous compliance.

ProcessX enables easy development (no code changes required), deployment, enhancement, and maintenance to keep the total cost of ownership down and reduce overall risk.

ProcessX also enables your enterprise to consolidate IT systems by bringing GxP and non-GxP processes onto a single platform, generating greater ROI for your ServiceNow investment. It also helps with better business insight and performance management in a single system.

How does ProcessX ensure we are staying continuously compliant with our regulated workflows and processes?

ProcessX includes automated functionality for validation and testing to maintain continuous compliance of ServiceNow and ProcessX. USDM’s proprietary Cloud Assurance^TM subscription service is bundled with ProcessX to manage patches and updates.

E-signature on mobile interfaces is not available in the ServiceNow Paris version. When will it be available and in what version will it be implemented?

For the purpose-built mobile application, eSignature through ProcessX is planned for version 2.0; however, a date for its release is not yet finalized.

If you are using a browser on a tablet, then eSignature is available in ProcessX.

Do you support mobile validation?

The ProcessX automation framework can handle validation for purpose-built mobile application and browser-based access from mobile devices; however, the automation framework cannot be ported into mobile devices at this time.

Is ProcessX an add-on for incident and change management processes? Does it add functionality to the current OOB ITSM processes?

ProcessX is an independent solution on top of the ServiceNow platform, but it can be integrated (bi-directionally) with an OOB ITSM solution to manage end-to-end incident and change management processes.

Moreover, ProcessX can be natively integrated with other applications built on ServiceNow or any other enterprise system by leveraging the Open-API (integration hub).

Do you offer training for ProcessX?

ProcessX comes with a training manual and user guide. USDM can provide additional training if needed.

What is the significance of the Built on Now? What does it mean?

Built on Now means that ProcessX received the highest technical designation and certification for a ServiceNow Technology Partner application. What that means is, ProcessX was designed and tested for fast, agile, and secure digital transformation and Built on Now provides you with One Platform, One Data Model, and One Architecture with the performance, security, and graphical user interface (GUI) of the ServiceNow platform.

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