2025 Audit Planning: 5 Things You Should Have Ready by Now
Audit program managers: this is your Q4 checklist. Are you ready for 2025?
With the FDA signaling more aggressive oversight in 2025, quality leaders can't afford to fall behind on audit planning. We're seeing the most prepared teams already locking in their audit schedules and securing key resources—knowing the best auditors' calendars fill up fast.
If you're still finalizing your 2025 approach, here are the five critical elements you should have ready now—along with the tough questions you need to ask yourself about each one. Your answers will reveal whether your audit program is truly prepared for what's ahead.
Still need to schedule your 2025 audits? Just a heads up that this year has been the busiest by far for audit planning in recent years. We're seeing RA/QA leaders prioritizing mock inspections, internal site audits, and vendor/supplier audits well into 2025. The FDA says 2025 will be a “crucial year” for working through its inspection backlog. If you have yet to schedule your audits and other compliance assuredness projects, demand for auditors and mock inspectors — particularly from former FDA professionals — is at an all-time high. We urge you to contact us as soon as possible to make sure resources are available for your audit schedule.
Here are the five critical elements you should have ready to ensure a strong start to your 2025 audit program.
1. Your annual data review and analysis
By now, you should have a clear picture of your 2024 audit performance. This means having compiled and analyzed all your audit reports from the current year, including internal, external, and supplier audits. Right now, you should be able to pull up a report showing your top recurring audit findings across sites/suppliers for 2024, and the effectiveness rate of the CAPAs you implemented to address them.
The most effective programs we see have already created a comprehensive findings database that tracks audit dates, types, departments, and CAPA status. Using pivot tables or similar analysis tools, you should be able to identify your top five most common finding categories and understand the frequency of findings across different departments or suppliers.
This analysis isn't just about collecting data — it's about understanding patterns and making sure subsequent audits focus on understanding those patterns better or monitoring progress around improvements.
Do you know which problem areas represent your biggest compliance risks across your sites and/or suppliers?
Do you know your CAPA effectiveness rates?
Are problem patterns getting better, worse, or static?
These insights are crucial for prioritizing your 2025 efforts and ensuring you focus resources where they're most needed.
2. Your regulatory intelligence update
The regulatory landscape is constantly evolving, and your 2025 audit program needs to reflect the latest requirements. By this point, you should have reviewed all new and updated FDA guidance documents from 2024 and updated your audit checklists accordingly.
More importantly, you should have completed impact assessments for any major regulatory changes affecting your product design, manufacturing processes, quality system, supply chain, labeling, or clinical/postmarket activities.
Your audit program needs to actively verify compliance with them. Have you mapped out how you'll assess adherence to new requirements across your organization?
To ensure your company's 2025 audit program aligns with the latest FDA requirements, here are just a few significant regulatory updates and final guidances issued in 2024 to consider:
Quality Management System Regulation (QMSR) Final Rule: In February, the FDA issued a final rule amending the Quality System Regulation (21 CFR Part 820) to align more closely with ISO 13485:2016, the international standard for medical device quality management systems. This harmonization emphasizes risk management and aims to reduce regulatory burdens on medical device manufacturers. The rule becomes effective on February 2, 2026, providing manufacturers time to adjust their quality systems accordingly. (Federal Register)
Regulation of Laboratory-Developed Tests (LDTs): In May 2024, the FDA finalized a rule explicitly stating that in vitro diagnostic products (IVDs), including those manufactured by laboratories, are medical devices under the Federal Food, Drug, and Cosmetic Act. This rule initiates a four-year phaseout of the FDA's general enforcement discretion approach for LDTs, requiring laboratories to comply with medical device regulations, including premarket review, quality system requirements, and adverse event reporting. The phased implementation allows laboratories to adapt to these new requirements over time. (FDA)
Control of Nitrosamine Impurities in Human Drugs: In September 2024, the FDA issued final guidance on controlling nitrosamine impurities in human drugs. This guidance outlines recommended acceptable intake limits for nitrosamine drug substance-related impurities (NDSRIs) and strategies for manufacturers to detect and prevent these impurities in drug products. (FDA)
Core Patient-Reported Outcomes in Cancer Clinical Trials: In October 2024, the FDA released final guidance on incorporating core patient-reported outcomes in cancer clinical trials. This guidance emphasizes the importance of capturing patients' perspectives on symptoms, side effects, and overall quality of life during clinical trials, ensuring that patient experiences are considered in evaluating cancer treatments. Incorporating these outcomes can enhance the relevance and impact of clinical trial data. (Federal Register)
Postapproval Manufacturing Changes for Biosimilars: In July 2024, the FDA released final guidance titled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." This document provides clarity on the types of information manufacturers should submit when implementing postapproval manufacturing changes for biosimilar products, ensuring continued product quality and compliance. (FDA)
3. Your risk assessment framework
A robust risk assessment should now be complete for all your auditable entities. This means conducting comprehensive risk scoring that considers past audit findings, quality metrics, process complexity, component criticality, and any recent changes in equipment or personnel.
You should have already grouped your entities into risk tiers (High/Medium/Low) to determine audit frequency for 2025.
Most importantly, you should have developed clear risk mitigation strategies for your top highest-risk entities. These strategies should inform both the timing and scope of your 2025 audits. If you haven't done this yet, it should be your immediate priority!
If you haven't completed your risk assessment for 2025's audit program yet, here's a straightforward framework you can implement immediately:
Step 1: Score Each Entity (1-5 Scale)
Score each department, supplier, or process on these key risk factors:
Past Audit Performance
Product Impact
Process Complexity
Change History
CAPA History
Regulatory History
Step 2: Calculate Risk Score
Use this weighted formula:
Total Risk Score = (Past Audit × 0.25) + (Product Impact × 0.25) + (Process Complexity × 0.15) + (Change History × 0.15) + (CAPA History × 0.10) + (Regulatory History × 0.10)
Step 3: Determine Audit Frequency
Based on the total score:
High Risk (4.0 - 5.0): Audit every 6 months
Medium Risk (2.5 - 3.9): Annual audit
Low Risk (1.0 - 2.4): Audit every year or 18-24 months
(These frequencies aren’t hard-and-fast — set them to what makes sense for your organization.)
Step 4: Document
For each entity, document:
Entity Name
Type (Department/Supplier/Process)
Last Audit Date
Individual risk scores
Total weighted score
Risk category
Required audit frequency
Required mitigation actions
Next audit due date
Special focus areas
The most proactive and sophisticated audit program managers we work with conduct their initial assessment in Q3 or Q4 for next year's planning, review it quarterly for high-risk entities, update scores when significant changes occur, and document evidence supporting each risk score. Once they have their audit frequency, they simply bring it to us, and we resource the audits with project management baked in.
4. Your resource plan and budget
Understanding your resource needs and securing the necessary budget is critical for successful audit execution. By now, you should have calculated your total required auditor days for 2025 and be in planning mode with your auditing partner.
Your budget should be detailed and comprehensive, including allocations for internal auditor time, external auditor fees, training costs, travel expenses, audit software or tools, and—crucially—contingency funds for unexpected audit needs.
Have you already identified and secured commitments from your preferred partners? Speaking from experience, we often book up quickly, especially for specialized assessments. Get in touch if you still need to add auditors to your audit plan for 2025.
Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.
Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf. Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.
Here’s a look at our proven process that has worked for the hundreds of firms that resource their audits with us:
5. Your master schedule
Perhaps most importantly, you should have a well-structured master audit schedule for 2025.
This schedule should prioritize high-risk audits early in the year, optimize geographic clustering for travel efficiency, and include adequate buffer time (we recommend 10%) between audits. Your schedule should also account for follow-up audits, particularly for high-risk areas, typically scheduled 6-8 months after initial audits.
Have you developed an auditor assignment matrix that matches expertise to audit types?
Have you accounted for operational constraints like planned shutdowns or peak production periods?
Don't forget to build in time for mandatory regulatory audits—these aren't negotiable and must be properly resourced.
Watch our interviews with Divya Gowdar and former FDA investigator Chris Smith for more insights into auditing and inspection readiness.
Need 2025 audit support support? Let’s talk.
Need rapid access to the industry’s top auditors? Contact us to access our exclusive pool of 2,500+ global consultants, 255+ of whom are former FDA.
If we haven't yet partnered on project support, we provide end-to-end audit support and intensive, comprehensive mock FDA inspections that not only mirror real inspections but go deeper — giving you the insights, corrections, and readiness you need before the FDA walks through your doors.
With a staff of thousands of resources worldwide, we're the partner firms work with when they want deep domain expertise and the peace of mind that comes with a partner whose commitment to quality and integrity reflects their own.
Whether you need a complete audit program design, full execution, or specific audit support, we're here to help. Drop us a line to start the conversation.
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