We mentioned several GxP use cases in Part 1 of this blog series, so let’s get into some details about what is possible with RPA.
Summary
Robotic process automation (RPA) lets life sciences teams hand repetitive, accuracy-critical work to software “digital employees” so people can focus on high-value tasks. This post walks through GxP-relevant use cases—complaint handling, supply chain, vendor management, back-office and HR, clinical trials data, and sales and marketing—then looks at how RPA augments human abilities in data migration, CRM and sales-order integration, regulatory compliance, and clinical data extraction. It closes with the USDM framework for delivering RPA with continuous compliance and audit-ready regulatory evidence.
Advanced analytics is where we’d all like to be with our regulated and non-regulated systems. We could create signaling algorithms, make validations and assessment much more efficient, and get quick answers to quality, safety, and regulatory questions. The path to this level of sophistication and technology starts with robotic process automation (RPA).
How much do you pay your employees to fill out their timecards?
The whole point of RPA is to automate repetitive tasks that employees are saddled with on a daily or weekly basis. Surely you’d rather have your people focused on high-value work that sees a return on your investment in them.
When tasks like data checking are cumbersome or lengthy but absolutely dependent on accuracy, RPA can do the work of several people, do it thoroughly (not just spot-checking the easy records), and do it in a fraction of the time. Automation is the answer to managing and safeguarding necessary processes and workflows.
When tasks are cumbersome but absolutely dependent on accuracy, RPA can do the work of several people—thoroughly, and in a fraction of the time.
What RPA can accomplish in the regulated life sciences industry
Every role in your company can benefit from automation. Research shows that, when employees can focus on their core responsibilities, it improves their job satisfaction and engagement. Following are just a few examples of what RPA can accomplish.
Complaint handling. Automated complaint handling can prevent the mis-categorization of complaints, ensure that complete data is collected, and that the complaint is properly submitted to the regulating body.
Supply chain. Automated processes include picking products in warehouses and sorting and analyzing laboratory samples. Optimizing supply chains ensures that supplies, materials, and key drugs are available when and where they are needed.
Vendor management. Automating vendor management means that you can keep third-party vendor access secure and compliant with a minimal time investment from your staff. Pairing automation with a disciplined approach to third-party risk management helps ensure that the vendors feeding your regulated processes stay within your risk tolerance.
Back-office areas like HR. RPA can yield greater productivity in audit trails, GxP, and tracking employee training and certifications.
Clinical trials data. RPA can improve the clinical trial process from startup to submission. Manual processes can be replaced by forms, and human error is dramatically reduced.
Sales and marketing. RPA can conduct industry research about market conditions, competitor pricing, and customer preferences. For example, a bot can track the campaigns and messaging being used by your competitors.
Why GxP changes the RPA equation: In regulated environments, a bot isn’t “done” when it runs—it’s done when its behavior is documented, tested, and defensible in an audit. That means risk-based testing, captured regulatory evidence, and change control built into the workflow from day one, not bolted on later.
Ways in which RPA augments human abilities
RPA bots can be assigned a single function or take over an entire workflow, so how do you want to increase efficiency and employ capabilities that extend human abilities? There are several success stories where these “digital employees” are accomplishing tasks in clinical, manufacturing, human resources, and on the shop floor.
Four high-impact ways RPA extends your team
Data Migration. RPA bots can be programmed to monitor the migration of data from old systems to new systems and identify and correct inconsistencies in real time. This saves you an enormous amount of time and money while providing error-free results—and it reinforces data integrity as records move between systems.
CRM and Sales Order Integration. When your salespeople enter opportunities into the customer relationship management (CRM) system, an RPA bot can check pricing, generate quotes and shipping times, and validate sales order data.
Regulatory Compliance. RPA simplifies the compliance process by providing accurate data processing, detailed records for audits, and real-time monitoring of all bot activities. Because the technology is rules-based, it can be updated to comply with new regulations—including controls that support 21 CFR Part 11 requirements for electronic records and signatures.
Clinical Data Extraction. RPA can help healthcare companies retrieve data from physical clinical documents and electronic health records. Bots can search databases for the correct documents and route them to the appropriate user within the healthcare company’s network.
USDM’s RPA capabilities
USDM can be your partner for making RPA a reality in your organization. Our internally developed framework considers the various aspects of the process from idea generation to design and development to risk-based testing. Of course, continuous compliance and capturing required regulatory evidence are always top-of-mind.
In one case study, for example, we applied our framework to complete a compliance assessment for GxP, non-GxP, and Software-as-a-Medical Device (SaMD), and differentiated between formal and informal testing to meet global regulatory requirements.
This tool-agnostic framework can be a blend of people, processes, and systems. We adhere to the best practice of using a DevOps framework to meet GxP testing requirements. We are currently engaged in:
- Developing a governance structure and workflows for custom, GxP-relevant use cases—the same kind of guardrails covered by our AI governance and compliance services
- Developing RPA bot workflows for DocuSign Part 11 Cloud Assurance
- Ongoing evaluation projects for RPA tools
Keeping automated, GxP-relevant systems in a validated state over time is exactly what USDM Cloud Assurance is built for—so your bots stay compliant as platforms and regulations evolve.
Don't miss Part 3 in this blog series where we share lessons learned in our on-going RPA journey.
Additional Resources
Here's a sneak peek of information presented by Stepheni Norton and Jim Lyle in the How to Maximize Your GxP Use of the Public Cloud webinar. For an in-depth look at RPA, test automation in action, and various use cases, watch the full-length on-demand webinar.
Watch the full-length on-demand webinar: How to Maximize Your GxP Use of the Public Cloud
FAQ: RPA for GxP-Relevant Use Cases
What is robotic process automation (RPA) in life sciences?
RPA uses software “digital employees” to automate repetitive, rules-based tasks—such as data checking, complaint handling, and clinical data extraction—so staff can focus on higher-value work. In regulated environments, the goal is to do this thoroughly and accurately while preserving compliance.
Which GxP-relevant processes are good candidates for RPA?
Strong candidates include complaint handling, supply chain operations, vendor management, back-office and HR tasks (such as audit trails and training tracking), clinical trials data, and sales and marketing research. RPA also augments human abilities in data migration, CRM and sales-order integration, regulatory compliance, and clinical data extraction.
How does RPA support regulatory compliance?
RPA provides accurate data processing, detailed records for audits, and real-time monitoring of bot activities. Because it is rules-based, it can be updated as regulations change—including controls that support 21 CFR Part 11 requirements for electronic records and signatures.
How does USDM keep RPA bots compliant?
USDM applies an internally developed, tool-agnostic framework that spans idea generation, design and development, and risk-based testing—with continuous compliance and captured regulatory evidence built in. A DevOps approach is used to meet GxP testing requirements, and validated state is maintained as platforms and regulations evolve.
Ready to put RPA to work in your regulated environment? Contact USDM for an evaluation of your processes and workflows and to learn how RPA can streamline your end-to-end operations—without compromising compliance.