Inspection Readiness in Pharmacovigilance: Q&A with a Safety Expert

Nov 11, 2025 | Christina Kim

Preparing for a pharmacovigilance (PV) inspection is an essential part of bringing a new drug to market and maintaining compliance. It’s a mindset reinforced by ongoing behaviors, not a one-time activity, according to Kwabena (KB) Boaten-Adusei, current pharmacovigilance quality assurance (PVQA) lead and a PV expert with 10+ years of experience in biopharmas and PV contract research organizations (CROs).

I recently sat down with KB to discuss best practices for safety inspection readiness — discussing what to expect from an inspector, how to leverage technology for a seamless audit, and ways to prepare partners and in-house teams for an inspection.

Q: How do you know an inspection is coming? Are they always announced?

KB: Safety inspections aren’t always announced. The FDA, for example, determines inspections based on a risk-based model that factors in the product, company history, and past compliance. An inspection can be triggered by a number of things, including patient safety issues, increased product complaints, operational compliance issues, or the submission of a new drug application (NDA). Essentially, if the FDA or regulatory authorities are receiving information about your company or product that suggests a risk to the public, expect them to come.

Companies with safety findings identified during previous inspections may be subject to unannounced inspections. For example, if the FDA issues a Form 483 at the conclusion of an inspection, they may conduct a follow-up inspection — possibly unannounced — within the next three-year inspection cycle to verify that corrective actions have been implemented. But, whether it’s a routine inspection or unannounced, PV teams must always be prepared. It’s not a matter of if, it’s a matter of when. Always expect to be inspected.

Q: What are the biggest challenges PV teams face during an inspection?

KB: Turnaround time for data requests can be a significant challenge, particularly when working with partners and vendors in different time zones. This issue is even more pronounced during unannounced inspections or audits, where timely responses are essential. For example, coordinating with a vendor in India from California involves a 13/14-hour time difference. Without adequate preparation and clearly predefined inspection responsibilities, this time lag can hinder the ability to provide prompt data or responses to inspectors, which may negatively impact the inspection outcome.

Another major risk PV teams face is a lack of oversight. Many small biotechs outsource various safety processes to CROs/service providers and need to have oversight into data and processes. Outsourcing can introduce additional risks if you or your partner have high turnover. For example, are new vendor employees being adequately trained before beginning work on your project? Are timelines being met? Sometimes vendor oversight goes by the wayside and ends up being an inspection finding. Which is why ultimately it’s the responsibility of the PV team to make sure they have adequate vendor oversight.

Lastly, one of the biggest headaches during inspections is working across five or six different systems – and it can be even more if quality management, document management, change control, and regulatory information management are all in different systems. So, a single platform approach is a benefit to inspection readiness.

Q: You mentioned the importance of being proactive. What else does “inspection readiness” entail?

KB: Inspection readiness is a mindset reinforced by ongoing behaviors, not an activity. Any time something changes, you need to update it, whether it’s a procedural change or an update to a job description.

Owning your own data can make a significant difference. As I mentioned, if I don’t have access to all the data in real-time, turnaround time may be an issue. If I don’t have a subject matter expert who understands the system and can quickly access information, data provision and validity will be an issue. This is another benefit of a platform approach. I don’t need to wait. With everything on one platform, you can configure reports and dashboards, allowing the team to access and visualize key information on demand.

Lastly, a key part of readiness is preparing your team. I use storyboards, which are proactive summaries of any known issues, corrective actions, and expected timelines. If an inspector comes in and identifies issues and no one can answer their questions about it, that’s a problem. Create a couple of slides to say, ‘This is the problem, this is what we’re doing about it, and this is the expected timeline for resolving it,’ to show you’re prepared.

Q: What’s the best way for sponsors to work with partners during an inspection?

KB: It’s a highly collaborative process. When an inspector asks about a specific process, the person or stakeholder who has the responsibility to perform that task or the accountability over the system in question should be available to answer. It’s important for sponsors to have members of the vendor’s project team on standby. In-house teams should be trained in their role-specific processes and be able to quickly locate standard operating procedures (SOPs) and procedural documents pertaining to these processes.

Q: We hear a lot about the Pharmacovigilance System Master File (PSMF) for EMA inspections. Is there a similar requirement for the FDA?

KB: The PSMF is a regulatory requirement that provides a comprehensive description of each aspect of a company’s PV system. Though it is a European requirement, a few other health authorities have adopted the PSMF. And personally, I’m of the opinion that maintaining a PSMF regardless of EMA approval is beneficial to maintain compliant PV systems. It serves as a single source of truth, making it a critical tool for audit and inspection readiness.

This is another area where having a single, in-house safety platform makes it much easier to quickly pull together documents and data to include in the PSMF. Although the PSMF isn’t required until the product is on the market, you don’t want to be scrambling, especially if you have an expedited approval. You’ll need to review the content within the PSMF on a periodic basis, so having these documents and data in a central location is going to make that easier and more efficient.

Four ways to improve inspection readiness

• Be proactive: Inspection readiness is a mindset reinforced by ongoing behaviors, not a one-time activity. All necessary documents, including SOPs, CVs, and job descriptions should be kept up-to-date in real time. Use storyboards to proactively address known issues. And, during the inspection, be deliberate with the flow of information by having a designated back room and technical setup for triaging requests.
• Embrace the PSMF: While not an FDA requirement, building and maintaining a PSMF is a best practice. As companies adopt modern PSMF solutions and technologies continue to advance, the PSMF can evolve from a repository of content to an asset for enabling real-time oversight of PV system performance, making any inspection significantly easier.
• Leverage technology for improved oversight: Owning your safety data and having real-time access gives your team the best oversight. A unified and connected platform for all safety, clinical, regulatory, and quality data allows for fast, on-demand reporting and eliminates time lag and risk associated with pulling information from disparate systems.
• Prepare partners for the process: During an inspection, the vendor should be available to speak to the processes and workflows they manage. But much of the preparation will begin well before an inspection. Clearly spell out partner roles and responsibilities in your contracts, and use ongoing training and regular touch points to ensure teams are aligned and surface any questions well in advance.

Learn how Veeva Safety Suite helps maintain inspection readiness on a unified and connected cloud platform.