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RPA GxP-relevant Use Cases

Best Practices for Complaint and Adverse Event System Implementation

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.

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.

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.

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.

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.

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.

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.

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
  • Developing RPA bot workflows for DocuSign Part 11 Cloud Assurance
  • Ongoing evaluation projects for RPA tools

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

Contact USDM for an evaluation of your processes and workflows and to learn how RPA can streamline your end-to-end operations.


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