Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assessments (RRA). The FDA wants to expand RRA across all product areas to supplement in-person inspections after it has proven to be effective.
The agency drafted the guidance under the FDA Good Guidance Practices regulation to explain its interpretation of RRA. The FDA will finalize the guidance after incorporating public and industry input. Although the final guidance for FDA remote regulatory assessments will be nonbinding, it represents the agency’s current thinking.
This article covers the current state of FDA remote regulatory assessments, and why an enterprise quality management system (EQMS) is a necessary prerequisite.
FDA Remote Regulatory Assessments: What, Who, Why
The draft proposal, “Conducting Remote Regulatory Assessments: Q&A,” was issued in July in accordance with FDA Good Guidance Practices regulation (21 CFR 10.115). “We intend to continue to use RRAs, as appropriate, according to a risk-based approach that best protects public health,” according to the FDA. “For example, when we are unable to deploy in-person staff due to travel restrictions, we may determine that RRA is an appropriate tool.” The agency is seeking comments from the industry until Sept. 23, 2022.
The FDA initially implemented RRAs to adapt to the disruptions stemming from the COVID-19 pandemic in 2020. Over the last two years, the agency has performed over 1,470 domestic and more than 600 foreign-entity RRAs. RRAs don’t replace other regulatory tools such as paper-document reviews, virtual site visits, or remote interactive evaluations, a type of RRA. Instead, RRAs complement FDA’s authority to conduct inspections under the Food, Drug and Cosmetic Act (FD&C Act).
The FDA uses RRA to examine a company’s records entirely remotely to support regulatory decisions and oversight activities. It can be either voluntary or mandatory. Mandatory RRAs apply to drug manufacturers and related companies subject to section 704(a)(4) of the FD&C Act. They also apply to importers covered by the Foreign Supplier Verification Program (FSVP). In addition, the FDA will extend invitations to conduct voluntary RRAs.
FDA remote regulatory assessments may be used for companies with a prior history of compliance. It may choose to use RRA if it helps in conducting elements of oversight or support regulatory decisions. For example, RRA may help prepare for an inspection, follow up on consumer complaints, or verify completion of corrective actions. To date, RRAs have included review of records or other information submitted upon request from the FDA.
EQMS Required FDA Remote Regulatory Assessments
Even prior to the pandemic, many life science and other regulated companies have been using remote audits for convenience and efficiency. Those companies have easily adapted to the FDA’s RRA and other remote tools at the peak of the global pandemic. Apart from the FDA, European regulatory and certification entities also embraced remote audits.
To be able to leverage RRA and other technology-driven regulatory tools, an enterprise-wide electronic quality management system (QMS) is a prerequisite. Here’s how an EQMS can help you optimize RRAs, remote audits, and other compliance activities when in-person meetings are impossible.
#1 Increase RRA convenience for regulators and users.
Companies that rely on manual quality processes will find it hard (if not impossible) to participate in an RRA. Even those that use electronic systems will have a tough time if those systems are unconnected. An EQMS provides a centralized platform for managing all compliance-related documents and tasks. You can rest assured that you’ll have a secure virtual workspace for an RRA. Everything that the FDA (or other auditor) needs will be in one place. A centralized platform also facilitates collaboration among users and makes it easier for them to participate in RRA-related activities.
#2 Streamline the RRA documentation and approval process.
In a regulated environment, if a compliance activity is not documented, then it didn’t happen. You need proper documentation for RRA, including document management and change control. RRA documentation and approval is likely to require collaboration, a laborious process in a manual or hybrid process. An EQMS will greatly increase efficiency by automating notification, routing, revision, escalation, and approval of RRA documentation in a secure platform.
#3 Make RRA documentation and training easier to implement.
Prepare your employees and stakeholders for RRA or remote audits with the right training and training tools. An EQMS with a robust training management capability makes it easier to create, distribute, and escalate RRA documentation and training tasks. The system provides automatic notification and verification of training tasks and tests. An EQMS also facilitates management of individual RRA documentation and training files. You don’t have to worry about incomplete or missing training records.
#4 Monitor quality issues in real time with the help of analytics and reporting capabilities.
An EQMS provides analytics and reporting tools to help identify and monitor issues before an RRA or remote audit. The capability to generate regular trend reports to spot risks is a major advantage of EQMS over a manual system. Choose a solution that will let you create both pre-configured and custom reports. Schedule regular reports for increased RRA readiness, oversight, and actionable intelligence.
#5 Make quality processes visible to stakeholders and regulators for a seamless RRA.
With an EQMS, all quality processes will be visible to users, stakeholders, and regulators, an important factor in RRA. Search features, dashboards, and change history all help in making processes transparent to regulators. Audit trail and electronic signatures capture the identities of users who request, approve, and implement changes and when they occurred.
#6 Adopt a holistic, risk-based approach to FDA compliance.
A closed-loop EQMS connects all quality processes that could impact RRA. It connects document control with training, corrective action and preventive action (CAPA), audit, supplier, and other critical processes for unified compliance. Under this approach, quality issues or trends that pose risks to product safety will be automatically identified and categorized. Depending on the severity of the risk, it may launch related tasks (e.g., CAPA, training, reporting, etc.).
FDA Remote Regulatory Assessments: Benefits
In proposing continued and expanded RRA use, the FDA identified some of the benefits of the practice, including verifying corrective actions and gaining compliance insight when it was not practicable to inspect on site. RRAs have also provided information about deficient practices, which led the agency to take regulatory actions, conduct inspections, or plan future inspections.
In the food and beverage industry, RRAs helped determine compliance with veterinary feed directive regulations, assess foreign manufacturing process records, add foreign firms to import alerts, and issue warning letters. More importantly, RRAs helped “reduce delays of, approval or authorization of marketing submissions for FDA-regulated products during the COVID-19 pandemic,” according to the agency.
For companies that participate in RRAs, now is the best time to switch from disparate electronic systems to a closed-loop EQMS. Even if RRA is not mandatory for your organization, will you be able to do it if the FDA invites you to a voluntary RRA? You may have the choice to decline, but if it’s because of continued reliance on a manual system, doing so could delay the review or authorization of your submissions. Most of all, are you equipped to adapt if another global disruption occurs that restricts in-person inspections and audits? Learning from the COVID-19 pandemic, there’s simply no turning back when it comes to the importance of technology in compliance.
About the Author
Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.