Adapted from a Phlexglobal webinar, “The Next Phase of Intelligent Regulatory Process Automation,” held April 20, 2022 and available on-demand here.
As Regulatory Information Management (RIM) systems continue to evolve, key functionality is emerging that is required to support increasingly complex global requirements. Among these critical functionality requirements are:
- product registration management
- submission planning
- health authority interaction management
- manufacturing change management
- business process automation
- configurable data capture
- automation assistance
Yet not all RIM systems are created equal - and must support your organization’s specific business requirements. Following are some key criteria to keep in mind as you explore your options for improving efficiency and accuracy in this critical area.
Easing the Regulatory Burden with Intelligent Automation
Innovative RIM solutions must focus on decreasing the compliance burden while enabling regulatory professionals to focus on important strategies and getting the most value from agency discussions. Modern solutions can decrease the time to approval with automated workflows that help teams respond to health authority queries more quickly and more accurately. By condensing this timeframe, the organization can potentially generate revenue more quickly.
Baseline capabilities for a modern RIM system include intelligent automation, leading practice workflows, Visio-like business process templates, and standard notifications – available out of the box. In addition, systems must be easily adaptable and configurable to align with any unique needs for data capture, allowing users to standardize the data captured for core activities based on their stage in the business process.
The result? Global regulatory teams thus stay aligned according to the organization’s standardized workflow, helping ensure that critical steps are completed in a timely fashion and regulatory commitments aren’t overlooked.
Global Access to One Source of Regulatory Information
A key benefit of a purpose-built RIM system is the ability to serve as a single source of truth for regulatory information, allowing standardized and streamlined regulatory operations across the organization. This greater consistency and accuracy also help teams better prepare for continually evolving industry initiatives and requirements.
For example, controlling critical regulatory information and establishing governance processes that ensure its accuracy over time enables greater agility as teams prepare to implement emerging regulatory data requirements like SPOR (the “P” of which now serves as the product data of record for submissions through DADI, for example) and controlled vocabularies such as MedDRA. These vocabularies can be integrated into the user experience to promote adoption and simplify the tasks of searching and selecting the appropriate terms or codes.
Supporting Cross-Functional Requirements and Business Processes
RIM systems have cross-functional reach and so must be easily configured to address cross-functional information requirements. Where possible, data standards, as well as standards of practice, should be implemented within the system so teams can take advantage of practical industry experiences and lessons learned to manage the information, processes, and required reporting.
The most recent Gens & Associates World Class RIM Survey listed 15 base capabilities and 10 connection points for RIM solutions being adopted by the group’s top performers. The connection points represent opportunities to define cross-functional master data (e.g., for product) and break down functional silos – for example by integrating cross-functional information, systems, and processes in areas like the trial master file (TMF), CTMS, data lakes, and safety/pharmacovigilance. Sophisticated manufacturing and change control systems are building these integrations into their software as well.
Content overlaps in regulatory and TMF systems such as investigator CVs, case report forms and FDA Form 1572s are a great example of such opportunities. RIM systems should recognize this content as a component of the TMF and enable greater content sharing and harmonization. Using automation and metadata, these systems can potentially trigger updates to the TMF system capturing submission status, dates, and more.
Generating Timely and Actionable Insight
Sophisticated and configurable reporting must be a priority in modern RIM systems. Leveraging the system and process connections that were noted above, these systems can now offer unprecedented visibility across global products and portfolios. Robust dashboards can now offer critical insights into the planning and tracking of regulatory information within a broader context.
These on-demand insights can trigger new processes and activities while alerts and notifications ensure that team members aren’t blindsided by unexpected or unplanned activities. Automated workflows are particularly helpful in the typical update and verification or review and approval processes.
Reporting requirements for RIM are also closely tied to the concept of having a single source of truth from which all stakeholders are pulling relevant information to support R&D or commercialization activities. The power of accurate, controlled, and centralized global regulatory product information cannot be overstated.
Built for Regulatory Teams, Not Programmers
Today’s RIM solutions must be easy to implement, adapt, validate, and revise. They must be flexible enough to handle emerging data standards and industry best practices while maintaining ongoing compliance and reducing the overall compliance burden. It’s a tall order but one that is being met with innovative technologies, standards, and practices.
How can an advanced RIM system help teams to focus on value-added tasks instead of wasting time on error-prone manual tasks and workarounds? As just one example, an automated workflow for the planning and tracking of renewals and health authority queries can support more responsive interactions with health authorities – while also improving the quality of those interactions.
Software Validation Is Essential
For any RIM solution, 21 CFR Part 11 compliance – as well as its counterparts in other regions such as EU Annex 11 – is assumed as a foundational requirement. Validation of the system and surrounding processes can no longer be the onerous task that traditional, on-premise solutions of the past required. Vendors should provide comprehensive validation support with documentation, scripts, and release notes to ease the validation burden.
Spreadsheets and SharePoint Are Increasingly Unusable in Today’s Regulatory Environment
During our webinar on advanced Regulatory Information Management capabilities, we conducted an informal poll of attendees asking how many unique registrations each company maintains. Two-thirds reported more than 11 registrations, with half of these respondents managing more than 100 registrations. More only importantly, only 16% said they were using a dedicated regulatory solution, with 36% using internal tools such as spreadsheets and SharePoint to manage registration information.
We are seeing a rapidly growing number of companies recognizing that yesterday’s tools are insufficient to manage today’s regulatory challenges – much less tomorrow’s. They understand that an effective RIM system can help them manage relevant regulatory data and content throughout the product lifecycle, increase confidence in data quality, improve compliance, and streamline operations.
Have questions about modern RIM systems? Contact us today to speak with a regulatory expert.