We recently published our comprehensive guide to annual audit planning and companion checklist for Q3.
To step back and tackle GxP audit planning more generally, we put a question to our account managers who build client audit schedules and our auditors who travel to the sites: what do teams get wrong about scheduling, and what would you tell them to do differently next year?
What came back was heavy on sequence, confirmation, and leaving room. Here are seven of them, roughly in the order we’d act on them.
Download our free Excel audit planning workbook if you haven’t already:
1. Place the hard audits first in the schedule
Most schedules get built easiest-first. These are usually the domestic sites, the suppliers you talk to every month, the ones where you already know who to call. The “harder” audits end up in whatever slots are left over simply because the extra work and stress of scheduling get put off until after the easy ones are done.
We suggest trying to flip it if this sounds familiar. Place the constrained audits first, while the calendar is still empty and the people who can run them are still available. That means the site is in a region you’ve never audited, the one that needs an auditor who speaks a different language, the one where the auditor has to hold two or three qualifications, and anywhere the site itself only has a narrow window.
Easy audits stay easy as we get closer to the end-of-year crunch time. Hard ones don’t!
2. Know what your interval means before you pick dates
“Annual” means different things in different quality systems. Maybe that’s the calendar year. Maybe it’s 12 months from the last audit date. Maybe it’s 12 months with a documented grace period. Some procedures measure from the report date rather than the audit date.
Check which one yours says before you assign quarters because the difference is real. A site audited in March 2026 under an anniversary-based interval can’t sit in November 2027 without a deviation. Under a calendar-year interval, maybe it can!
Teams find this out after the schedule is locked more often than you’d expect.
3. Give one person the “pen” on every audit
One of the more common scheduling hiccups we see has nothing to do with auditor availability. It’s both sides assuming the other one is contacting the site.
Decide per audit, in writing, who books it. If you’re keeping the site relationships, your resourcing partner works through you on availability and you make the calls. If they’re coordinating, they need the contact name and the authority to reach out directly.
Either model works fine. A schedule where that field is blank invites problems that can always be avoided.
4. Confirm people along with dates
A confirmed date isn’t a confirmed audit. The SME who owns the system being audited must be on site that week, and so must someone with the authority to attend the closing meeting and respond to findings.
Ask the site to confirm attendee availability alongside the date. Name the closing meeting attendees when the agenda goes out, and send that agenda earlier than feels necessary, because the site needs some lead time to pull records.
Auditors tell us the audits that could have gone more smoothly from a logistics standpoint are usually the ones where the right person turned out to be on vacation or otherwise not available, and nobody had checked.
5. Leave report time between audits
Report writing is part of the audit, not something that happens afterward in spare time. Booking an auditor Monday and Tuesday at one site and Wednesday and Thursday at another looks efficient on a calendar, but in practice, the first report gets written on a plane or in a hotel room or three weeks later, and findings are always sharpest when they’re written while the evidence is fresh.
Whenever possible, leave a few days between audits for the same auditor. If you’re combining two sites into one trip to save on travel, try to build in a buffer day, because a closing meeting that runs long at the first site will eat the opening at the second.
6. Decide on-site or remote before you book
Remote and hybrid audits work well a lot of the time, but they depend on things that take time to arrange:
Document portal access with the right permissions.
A site contact who can carry a camera through a facility and knows where they’re going.
Enough bandwidth for that to actually function.
Enough timezone overlap for a real working day.
Pick the mode when you build the schedule. Switching from on-site to remote three weeks out usually means the remote audit happens without the setup it needed, and everyone has a worse time.
7. Plan for the 10 to 15% that will move
Some share of your audits will move no matter how well you plan. Sites get inspected, contacts leave, and other things happen. A supplier has a recall and goes dark for a month.
If your calendar is packed to capacity, the first cancellation has nowhere to land, and it starts a chain reaction that ends with two audits falling out of Q4. Leave slack in Q2 and Q3 on purpose. That’s where a displaced audit can go without pushing anything else out. A schedule with room in it absorbs surprises. A full one is “fragile” and can easily break from things outside your control.
Putting it into a planning sheet
None of this is particularly complicated, but it's much easier to hold in a spreadsheet than in your head. Our free audit planning workbook gives you a row per audit with fields for most of what's above: mode, duration, fixed dates, site contact, who's coordinating, and which auditor you want back.
And if you’re looking at a 2027 schedule you still need to resource, now is the right time to talk. We cover GMP, GCP, GLP, GCLP, CSV, pharmacovigilance, and quality system audits worldwide. One proposal can cover your whole program, and you can add to it or drop from it as the year moves.
We’ve had quite a few conversations about everything auditing. Check them out if you haven’t already:
Thermo Fisher Scientific’s Director of Corporate Quality, David Festa, gives some advice on approaching supplier audits:
NubGenix’s Founder and CEO, Divya Gowdar, discusses the pitfalls and lessons learned on the front lines of audit and inspection readiness throughout the FDA-regulated industries:
And it’s an oldie, but a goodie, our conversation about the ins and outs of FDA PAIs with former FDA investigator, Chris Smith:
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