Life sciences organizations must adhere to laws, regulations, and standards to ensure compliance. Start with a regulatory applicability assessment.
What is a regulatory applicability assessment and why is it so important? In this blog, we’ll explain its significance, the assessment process, and its benefits.
What is a Regulatory Applicability Assessment?
A regulatory applicability assessment helps life sciences organizations identify and evaluate which laws, regulations, standards, and other compliance requirements apply to their operations, products, or services. It’s the first step in awareness and shows that your organization is proactive in managing its legal and regulatory responsibilities.
For organizations operating in multiple jurisdictions, understanding regulatory compliance is necessary for market entry and sustainability. In addition to providing a clear picture for market access, regulatory applicability assessments bolster:
- Risk Management. Mitigate the risk of non-compliance—which can lead to significant financial penalties, legal actions, and damage to your organization’s reputation—by identifying and addressing regulatory requirements.
- Operational Efficiency. Streamline processes, allocate resources more effectively, and ensure that your compliance efforts are targeted and efficient.
- Stakeholder Confidence. Demonstrate your commitment to compliance and enhance stakeholder (customers, investors, partners) trust in your processes.
How the Regulatory Applicability Assessment is Conducted
To deliver benefits like proactive compliance management, enhanced risk management, operational efficiency, and stakeholder confidence, a regulatory applicability assessment takes you through:
- Defining the scope. Identify the specific operations, products, or services in your organization that will be evaluated. Include geographical areas where you operate.
- Identifying relevant regulations. Determine what fits your defined scope; for example, industry-specific regulations, environmental laws, health and safety standards, and data protection laws.
- Conducting a gap analysis. Compare your current practices with regulatory requirements to find areas of non-compliance or potential risk.
- Developing an action plan. Decide how to address gaps and what steps to take to achieve compliance. Be sure to include timelines, responsibilities, and resource allocation.
- Monitoring compliance. Ensure continuous compliance with regular audits, updates to policies and procedures, and employee training.
- Documenting and reporting. Demonstrate compliance to regulators and to your organization’s stakeholders. Document the results of the regulatory applicability assessment and actions taken and be prepared to report on them as needed.
To automate and simplify the assessment process for your organization, turn to ProcessX. Validation lifecycle management (VLM) is part of application lifecycle management (ALM) in ProcessX and encompasses user access management, periodic review, regulatory applicability assessments, and incident management. The regulatory applicability workflow drives the GxP system assessment process.
ProcessX also uses the regulatory applicability assessment to help you determine periodic review frequency and scheduling. Periodic review of systems, processes, and procedures identifies any changes made since the last review and determines the actions required to maintain a validated state. If the outcome indicates that revalidation of a low-risk process is necessary, then validation activities are performed again.
Why Integrate Cloud Assurance as a Platform with VLM in ProcessX
Cloud Assurance as a Platform (CAaaP) is a cloud-based solution that automates the validation and testing of applications and software. It seamlessly integrates with the VLM workflow in ProcessX and provides a single source of truth to manage everything associated with ALM, including regulatory applicability assessments.
Additionally, the CAaaP and ProcessX solution enables your organization to:
- Speed your time to market. Move from manual testing to automated testing to streamline validation, simplify release management activities, and eliminate deviations.
- Maintain audit readiness. Automate documentation, validation processes, and compliance checks to reduce the manual effort and be prepared for audits and inspections.
- Lower your IT cost of ownership. Acquire the technology, systems, and applications that meet regulatory requirements and fulfill their intended purposes.
- Implement AI and machine learning. Reveal untapped potential from real-world evidence to accelerate innovation and product development.
- Amplify digital quality. Integrate digital technologies with quality assurance and quality control processes to ensure that data is accurate, consistent, and retrievable throughout its lifecycle.
Where to Go from Here
A regulatory applicability assessment is an important tool for being proactive and achieving regulatory compliance. Contact USDM today to determine what compliance requirements your organization is obligated to meet and whether you have systems in place to demonstrate due diligence.
We’ll help you automate your regulatory applicability assessment, drive system categorization for computer system validation (CSV), and link your change process to the validation process. It’s all accomplished in ProcessX and maintains continuous compliance with the help of CAaaP.
