Ask most people what inspection readiness means and you’ll hear about a scramble: pulling documents together, briefing colleagues, running mock inspections in the weeks before the real thing. That picture isn’t wrong, it’s just incomplete, and it puts the emphasis in the wrong place.
Inspection readiness isn’t the output of one function or one team, and it isn’t something you assemble on short notice. It’s what happens when standardized, repeatable, and documented procedures are applied consistently across every program, every day, whether an inspection is on the calendar or not. A clean inspection record doesn’t reflect a good week of preparation. It reflects years of process discipline across the organization.
UBC has been through four FDA inspections of its offices, in 2012, 2014 (two) and 2015, with zero Form 483 observations. That result did not come from good timing. It came from the same procedures running the same way whether an inspection was scheduled or not.
What “Inspection-Ready” Actually Requires
Being inspection ready starts well before an inspection is scheduled. A few things must hold true all the time, not just when it counts.
- Documented, current SOPs that reflect what teams actually do, not just what’s written down, backed by a comprehensive, current PV system, including a complete pharmacovigilance system master file maintained for every client, not only those with an EU-linked obligation to have one.
- Ongoing internal quality checks built into normal operations, rather than a review that only happens ahead of an audit.
- Clear roles and accountability at the project level, so responsibility for readiness doesn’t sit with one function or one person.
- Training and version control that keep pace with regulatory changes, so procedures reflect current requirements rather than the requirements in place when they were written.
- A corrective and preventive action (CAPA) process governed by SOP, with target timelines set by severity: 60 calendar days for critical issues and 90 for major and minor issues, measured from the completed CAPA plan and receipt of objective evidence.
None of this is glamorous. It’s also the entire reason inspection readiness is consistent instead of situational.
The Track Record
UBC has completed four FDA inspections of its offices. The same procedures support clients when their regulators come calling. Between 2023 and 2025, UBC supported 38 PV inspections on behalf of clients, including 9 by the FDA, 5 by the EMA and 3 by Health Canada, across more than a dozen regulators in North America, Europe, Asia, Latin America and Africa. Over the same three years, UBC completed 54 PV client audits, and 51 of them raised no critical finding.
Inspections and audits do produce findings, and that is expected. What matters is that the system is built to surface them, document them and correct them.
| TRACK RECORD AT A GLANCE | |
| 4 | FDA inspections of UBC offices, zero Form 483 observations |
| 38 | PV inspections supported for clients, 2023 to 2025, across more than a dozen regulators worldwide |
| 54 | PV client audits completed, 2023 to 2025 |
| 51 of 54 | PV client audits with no critical finding raised |
What This Looks Like at the Project Level
The procedures behind that track record apply to every program, and they flex to fit it. When a client inspection is announced, UBC has a process to set up inspection logistics quickly and a well-defined hosting process, so teams know who does what from the first day. Behind that sits the documentation an inspector will ask for, including the pharmacovigilance system master file, kept current as a standing document rather than assembled for the occasion.
These procedures scale with the program. A single-site study and a multi-region program with multiple vendors don’t need the same setup, but they need the same discipline behind them.
Consider a mid-sized safety program spanning several markets. Case processing, signal detection, and reporting each have a designated owner, a documented procedure, and a defined review cadence, independent of any one person’s day-to-day availability. When staff changes or a new market comes online, the procedures already account for it. Nothing has to be reconstructed under time pressure, because there isn’t a moment when readiness starts. It’s already running.
What Sponsors Should Look for When Evaluating a Partner
Inspection history tells you what already happened. It’s a fair question to ask, but it’s a backward-looking one. The more useful questions get at what a partner does on an ordinary Tuesday, not just how they perform under a Health Authority’s attention. When evaluating a PV partner’s readiness posture, ask:
- How often are SOPs reviewed and by whom, and how is that reflected in version control?
- What does an internal quality check look like outside of audit season?
- Who owns inspection readiness at the project level, and what happens if that person leaves?
- Can you walk me through a recent internal finding and what changed as a result?
- How is the pharmacovigilance system master file maintained, and is that consistent across all clients or only those with an EU requirement?
The answers reveal whether readiness is built into how a program runs or reconstructed when it’s needed. Vague answers, or answers that only reference the last audit, are usually a sign of the latter.
Readiness Is a Daily Discipline
Inspection readiness isn’t a state a program reaches and then holds. It’s a habit, renewed every day through the same procedures, the same accountability, and the same quality checks, regardless of what’s on the audit calendar. The organizations with strong inspection records aren’t the ones that prepare well. They’re the ones that never really stop.
Inspection readiness isn’t a state a program reaches and then holds. It’s a habit, renewed every day through the same procedures, the same accountability, and the same quality checks, regardless of what’s on the audit calendar. The organizations with strong inspection records aren’t the ones that prepare well. They’re the ones that never really stop.
If you’re planning ahead of an audit cycle or want to talk through what a procedure-driven readiness program looks like for your project, connect with UBC’s PV team.
About UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. UBC leads the market in providing integrated, comprehensive clinical, safety, and commercialization services and is uniquely positioned to seamlessly integrate best-in-class services throughout the lifecycle of a product.
About the Author
Tom Coles, Director, Pharmacovigilance
Tom Coles, Director, Pharmacovigilance, has over 10 years’ experience in the pharmacovigilance industry, Tom has overseen case processing teams in pharma and CRO settings, managed client PV systems and projects, authored aggregate reports across multiple indications, serves as the product expert for signal risk management and represented PV for business development activities. Tom is specialized in helping Chinese pharma companies enter the global market, ensuring their PV Systems are fit-for-purpose. At UBC, Tom is part of the PV leadership team and leads the Process Excellence function which manages and maintains client PSMFs, as well as the coordination of PV process documents, compliance, regulatory intelligence, and safety incident reports.
