12 Most Important Regulatory Affairs KPIs


The top KPIs in Regulatory Affairs are essential for monitoring the effectiveness and efficiency of a legal team's compliance processes. They provide measurable values that help teams to track their progress against specific regulatory goals and objectives, ensuring that all legal requirements are met within the stipulated timelines.

With KPIs, organizations can identify areas that require improvement, allocate resources more effectively, and reduce the risk of non-compliance penalties.

This article showcases the Most Critical 12 KPIs for Regulatory Affairs and Associated Benchmarks.

1. Regulatory Compliance Rate

Regulatory Compliance Rate is a critical KPI that reflects an organization's adherence to laws and regulations, impacting financial health and operational efficiency.

High compliance rates can lead to reduced legal risks, improved brand reputation, and enhanced customer trust. Conversely, low rates may indicate potential liabilities and operational weaknesses.

Organizations that prioritize compliance often see better strategic alignment and improved business outcomes. Learn more about the Regulatory Compliance Rate KPI.

View Common Pitfalls
View Improvement Levers

We have 1 benchmark for this KPI available in our database.

View Regulatory Compliance Rate Benchmarks

2. Safety Incident Reporting Compliance

Safety Incident Reporting Compliance is crucial for organizations aiming to enhance operational efficiency and ensure employee well-being.

High compliance rates indicate a proactive approach to safety, which can lead to reduced incidents and lower insurance costs. This KPI influences business outcomes such as employee morale, regulatory compliance, and overall financial health.

Organizations that prioritize safety reporting cultivate a culture of transparency and accountability, ultimately driving better performance indicators. Learn more about the Safety Incident Reporting Compliance KPI.

View Common Pitfalls
View Improvement Levers

We have 4 benchmarks for this KPI available in our database.

View Safety Incident Reporting Compliance Benchmarks

What is the standard formula?
(Number of Compliant Safety Incident Reports / Total Number of Safety Incidents) * 100

3. Data Privacy Compliance Rate

Data Privacy Compliance Rate is crucial for organizations navigating regulatory landscapes and safeguarding customer trust.

High compliance rates enhance operational efficiency, reduce legal risks, and foster data-driven decision-making. Companies with robust compliance frameworks often see improved financial health and customer loyalty, translating into better business outcomes.

As data breaches become more prevalent, maintaining a strong compliance rate is not just a regulatory necessity but a strategic imperative. Learn more about the Data Privacy Compliance Rate KPI.

View Common Pitfalls
View Improvement Levers

We have 1 benchmark for this KPI available in our database.

View Data Privacy Compliance Rate Benchmarks

4. Anti-Corruption Compliance Rate

Anti-Corruption Compliance Rate is critical for organizations aiming to uphold integrity and transparency.

High compliance rates can lead to enhanced trust with stakeholders and improved financial health, while low rates may expose firms to legal risks and reputational damage. Companies that prioritize this KPI often see better operational efficiency and reduced costs associated with compliance breaches.

By embedding this metric into a robust KPI framework, organizations can track results effectively and ensure strategic alignment with ethical standards. Learn more about the Anti-Corruption Compliance Rate KPI.

View Common Pitfalls
View Improvement Levers

We have 1 benchmark for this KPI available in our database.

View Anti-Corruption Compliance Rate Benchmarks

What is the standard formula?
(Number of Compliant Business Units / Total Number of Business Units) * 100

5. Environmental Compliance Rate

Environmental Compliance Rate is crucial for assessing a company's adherence to environmental regulations and standards.

High compliance rates can lead to reduced legal risks, enhanced brand reputation, and improved operational efficiency. Companies with strong compliance frameworks often experience lower costs related to fines and remediation efforts.

This KPI serves as a leading indicator of a firm's commitment to sustainability, influencing stakeholder trust and investment decisions. Learn more about the Environmental Compliance Rate KPI.

View Common Pitfalls
View Improvement Levers

We have 7 benchmarks for this KPI available in our database.

View Environmental Compliance Rate Benchmarks

6. Pharmacovigilance Compliance Rate

Pharmacovigilance Compliance Rate is crucial for ensuring drug safety and regulatory adherence.

High compliance rates enhance trust with stakeholders and minimize legal risks, directly impacting financial health. Organizations with strong compliance frameworks can better manage operational efficiency and improve patient outcomes.

This KPI serves as a leading indicator of overall pharmacovigilance effectiveness, guiding data-driven decisions that align with strategic objectives. Learn more about the Pharmacovigilance Compliance Rate KPI.

View Common Pitfalls
View Improvement Levers

We have 3 benchmarks for this KPI available in our database.

View Pharmacovigilance Compliance Rate Benchmarks

What is the standard formula?
(Number of Compliant Pharmacovigilance Activities / Total Pharmacovigilance Activities) * 100


Related KPI Categories

7. Chemical Substance Compliance Rate

Chemical Substance Compliance Rate is a critical performance indicator that measures adherence to regulatory standards in chemical management.

High compliance rates can lead to improved operational efficiency, reduced legal risks, and enhanced brand reputation. Organizations that prioritize this KPI often see better financial health and lower costs associated with non-compliance penalties.

By leveraging data-driven decision-making, companies can align their compliance strategies with overall business objectives, ensuring sustainable growth. Learn more about the Chemical Substance Compliance Rate KPI.

View Common Pitfalls
View Improvement Levers

We have 15 benchmarks for this KPI available in our database.

View Chemical Substance Compliance Rate Benchmarks

What is the standard formula?
(Number of Compliant Products / Total Number of Products) * 100

8. Conflict Minerals Compliance Rate

Conflict Minerals Compliance Rate is crucial for organizations aiming to uphold ethical sourcing standards and mitigate reputational risks.

This KPI directly influences supply chain integrity, regulatory compliance, and stakeholder trust. A high compliance rate signals effective management of sourcing practices, while a low rate may expose firms to legal liabilities and consumer backlash.

By tracking this metric, companies can align their operations with strategic goals, ensuring a sustainable business outcome. Learn more about the Conflict Minerals Compliance Rate KPI.

View Common Pitfalls
View Improvement Levers

We have 2 benchmarks for this KPI available in our database.

View Conflict Minerals Compliance Rate Benchmarks

What is the standard formula?
(Number of Compliant Products / Total Number of Products) * 100

9. Accessibility Compliance Rate

Accessibility Compliance Rate is crucial for ensuring that digital platforms meet regulatory standards and provide equal access to all users.

High compliance rates can lead to improved user experience, increased customer satisfaction, and enhanced brand reputation. Organizations that prioritize accessibility often see a positive impact on their financial health, as they can tap into a broader customer base.

Furthermore, this KPI serves as a leading indicator of operational efficiency and strategic alignment with inclusivity goals. Learn more about the Accessibility Compliance Rate KPI.

View Common Pitfalls
View Improvement Levers

We have 3 benchmarks for this KPI available in our database.

View Accessibility Compliance Rate Benchmarks

What is the standard formula?
(Number of Accessible Products or Services / Total Number of Products or Services) * 100


Related KPI Categories

10. Regulatory Audit Pass Rate

Regulatory Audit Pass Rate is a critical KPI that reflects an organization's compliance with industry regulations and standards.

A high pass rate indicates robust internal controls and operational efficiency, while a low rate can expose vulnerabilities that may lead to financial penalties or reputational damage. This metric directly influences financial health, risk management, and strategic alignment.

Organizations that consistently achieve high pass rates can better allocate resources, improve ROI metrics, and enhance stakeholder trust. Learn more about the Regulatory Audit Pass Rate KPI.

View Common Pitfalls
View Improvement Levers

We have 2 benchmarks for this KPI available in our database.

View Regulatory Audit Pass Rate Benchmarks

What is the standard formula?
(Number of Successful Audits / Total Number of Audits) * 100


Related KPI Categories

11. Regulatory Filings Timeliness

Regulatory Filings Timeliness is a critical KPI that reflects an organization's ability to meet compliance deadlines, impacting financial health and operational efficiency.

Timely filings enhance transparency, reduce regulatory risks, and foster trust with stakeholders. Companies that excel in this area often see improved ROI metrics and strategic alignment with industry standards.

A focus on this metric can lead to better forecasting accuracy and more effective management reporting. Learn more about the Regulatory Filings Timeliness KPI.

View Common Pitfalls
View Improvement Levers

We have 3 benchmarks for this KPI available in our database.

View Regulatory Filings Timeliness Benchmarks

What is the standard formula?
(Number of Timely Filings / Total Number of Filings) * 100


Related KPI Categories

12. Regulatory Issue Resolution Time

Regulatory Issue Resolution Time is a critical KPI that reflects an organization's ability to address compliance challenges efficiently.

It directly influences operational efficiency, risk management, and overall financial health. A shorter resolution time indicates proactive governance and effective communication, while longer times may signal systemic issues or resource constraints.

Companies that excel in this metric often enjoy improved stakeholder trust and reduced regulatory penalties. Learn more about the Regulatory Issue Resolution Time KPI.

View Common Pitfalls
View Improvement Levers

We have 1 benchmark for this KPI available in our database.

View Regulatory Issue Resolution Time Benchmarks

What is the standard formula?
Average Time Taken to Resolve Regulatory Issues


Related KPI Categories


These 12 KPIs were selected to provide a comprehensive view of Regulatory Affairs performance, balancing compliance across operational, safety, and environmental domains. They integrate leading indicators like Regulatory Filings Timeliness with lagging metrics such as Regulatory Audit Pass Rate, ensuring coverage from process execution to outcome validation. This subset reflects the multidimensional scope of Regulatory Affairs, spanning product, safety, and ethical compliance.

Track Regulatory Compliance Rate alongside Safety Incident Reporting Compliance to detect gaps between general compliance and safety-specific adherence. A decline in Safety Incident Reporting Compliance with stable Regulatory Compliance Rate signals underreporting risks. Monitor Regulatory Filings Timeliness in relation to Regulatory Issue Resolution Time—delays in filings paired with prolonged issue resolution indicate process bottlenecks requiring immediate attention. Environmental Compliance Rate and Anti-Corruption Compliance Rate often correlate; divergence suggests isolated risks in sustainability or ethics that need targeted mitigation.

Prioritize implementation of Regulatory Compliance Rate and Regulatory Filings Timeliness first, as these KPIs rely on readily available data and offer immediate visibility into compliance health and process efficiency. Follow with Regulatory Audit Pass Rate to validate compliance effectiveness and identify systemic weaknesses. The full Regulatory Affairs KPI set, with detailed formulas and benchmarks, is available in the KPI Depot database.

Subscribe for Full Access to KPI Depot
Unlock smarter decisions with instant access to 20,000+ KPIs and 30,000+ benchmarks. Only $199/year.


Subscribe Today for Only $199


KPI Depot (formerly the Flevy KPI Library) is a comprehensive, fully searchable database of over 20,000+ KPIs and 30,000+ benchmarks. Each KPI is documented with 12 practical attributes that take you from definition to real-world application (definition, business insights, measurement approach, formula, trend analysis, diagnostics, tips, visualization ideas, risk warnings, tools & tech, integration points, and change impact).

KPI categories span every major corporate function and more than 150+ industries, giving executives, analysts, and consultants an instant, plug-and-play reference for building scorecards, dashboards, and data-driven strategies.

Our team is constantly expanding our KPI database and benchmarks database.

Got a question? Email us at support@kpidepot.com.



Each KPI in our knowledge base includes 12 attributes.

KPI Definition

A clear explanation of what the KPI measures

Potential Business Insights

The typical business insights we expect to gain through the tracking of this KPI

Measurement Approach

An outline of the approach or process followed to measure this KPI

Standard Formula

The standard formula organizations use to calculate this KPI

Trend Analysis

Insights into how the KPI tends to evolve over time and what trends could indicate positive or negative performance shifts

Diagnostic Questions

Questions to ask to better understand your current position is for the KPI and how it can improve

Actionable Tips

Practical, actionable tips for improving the KPI, which might involve operational changes, strategic shifts, or tactical actions

Visualization Suggestions

Recommended charts or graphs that best represent the trends and patterns around the KPI for more effective reporting and decision-making

Risk Warnings

Potential risks or warnings signs that could indicate underlying issues that require immediate attention

Tools & Technologies

Suggested tools, technologies, and software that can help in tracking and analyzing the KPI more effectively

Integration Points

How the KPI can be integrated with other business systems and processes for holistic strategic performance management

Change Impact

Explanation of how changes in the KPI can impact other KPIs and what kind of changes can be expected


Compare Our Plans


FAQs about KPI Depot


What does unlimited web access mean?

Our complete KPI and benchmark database is viewable online. Unlimited web access means you can browse as much of our online KPI and benchmark database as you'd like, with no limitations or restrictions (e.g. certain number of views per month). You are only restricted on the quantity of CSV downloads (see question below).

Can I download a KPI group (e.g. Competitive Benchmarking KPIs)?

Yes. You can download a complete KPI group (which includes all inclusive KPIs and respective attributes data) as a CSV file. Basic plan subscribers receive 5 downloads a month; Pro plan subscribers receive 20 downloads a month.

To gain a better sense of the KPI data included, you can download a sample CSV file here. Note the CSV download only includes KPI attribute data; and not benchmark data.

Can I can cancel at any time?

Yes. You can cancel your subscription at any time. After cancellation, your KPI Depot subscription will remain active until the end of the current billing period.

Do you offer a free trial?

We allow you to preview all of our KPI groups. If you are not a KPI Depot subscriber, you can only see the first 3 KPIs in each group.

What if I can't find a particular set of KPIs?

Please email us at support@kpidepot.com if you can't find what you need. Since our database is so vast, sometimes it may be difficult to find what you need. If we discover we don't have what you need, our research team will work on incorporating the missing KPIs. Turnaround time for these situations is typically 1 business week.

Where do you source your benchmark data?

We compile benchmarks from multiple high-quality sources and document the provenance for each metric. Our inputs include:

Each benchmark lists its source attribution and last-updated date where available. We are constantly refreshing our database with new and updated data points.

Do you provide citations or references for the original benchmark source?

Yes. Every benchmark data point includes a full citation and structured context. Where available, we display:

We cite the original publisher and link directly to the source (or an archived link) when possible. Many KPIs have multiple independent benchmarks; each appears as its own entry with its own citation.

What payment methods do you accept?

We accept a comprehensive range of payment methods, including Visa, Mastercard, American Express, Apple Pay, Google Pay, and various region-specific options, all through Stripe's secure platform. Stripe is our payment processor and is also used by Amazon, Walmart, Target, Apple, and Samsung, reflecting its reliability and widespread trust in the industry.

Are multi-user corporate plans available?

Yes. Please contact us at support@kpidepot.com with your specific needs.