Prove your recall and CAPA. Before the inspector does.
Simulate recalls, deviations and CAPA response under realistic operational conditions.
What if the entire exercise, from scenario to inspection-ready report, took less than 60 minutes? You could run it this week.
Mapped to 21 CFR Part 211 · EU GMP · PIC/S · ICH Q10 · TGA · and more
Why now
Most recall delays start with coordination, not traceability
Quality, regulatory, manufacturing and supply chain teams often operate well independently, but pressure exposes escalation gaps and slow decision-making between functions.
Modern inspections focus on operational execution
Inspectors increasingly probe how recalls, deviations and CAPA processes work in practice, especially under time pressure and cross-functional disruption.
Global supply chains have expanded GMP exposure
CDMOs, API suppliers, packaging providers and logistics partners now sit directly inside your quality and compliance perimeter. A single weak process can rapidly become a regulatory event.
The frameworks behind every FDA inspection, GMP audit and regulatory submission
21 CFR 211.150 requires written procedures for distribution and lot-traceability to facilitate recall. In Australia, the TGA Procedure for Recalls, Product Alerts and Product Corrections (PRAC) has replaced URPTG and now governs all sponsor market actions. EU GMP Chapter 8 requires recall arrangements to be periodically evaluated.
CAPA framed as an investigation-and-effectiveness system. CAPA discipline is the single most-cited Form 483 deficiency. The TGA adopts the PIC/S Guide to GMP for medicinal products by reference, so PIC/S Chapter 1 quality system expectations apply to Australian licensed manufacturers.
Don't see your framework?
Handrails covers more than recall and CAPA. If your obligation is listed here, or you don't see it at all, let us know.
- PharmacovigilanceReporting under expedited and periodic clocks. AE clusters and signal detection drive the timing. The TGA requires sponsors to report serious unexpected ADRs within 15 days and to submit Periodic Safety Update Reports on schedule. Primarily relevant for innovators, branded manufacturers and QPPVs.
- Data IntegrityPart 11 covers electronic records and signatures. Annex 11 covers computerized systems and data integrity. Relevant when cyber events affect validated systems, data integrity, batch disposition or release decisions.
From scenario to inspection-ready report, in under 60 minutes.
Built around your context
Answer a few questions about your setup, including your business type (innovator, generic, biologic, CMO), regulatory regimes, manufacturing footprint and OT / data integrity exposure. The scenario is tuned to the obligations actually in scope, not a generic template. Hours of consultant prep, designed in minutes.
Run it live, virtually
Your team joins a video call. QA, RA, Manufacturing, PV / QPPV, Supply Chain and senior management observers in the same call; each function makes the decisions they'd actually make. The recording is the evidence stream. Scheduling is the only setup.
The report is ready before you close the call
Results generated in minutes, logged against your internal SOPs and what regulators demand. See areas for improvement and re-run quarterly to show the improvement curve inspectors and senior management now want to see.
Tailored, not templated
Critical deviation requiring CAPA
Sterility failure on a parenteral lot. Root-cause investigation, batch release decision, FDA notification, TGA PRAC market action assessment, EU competent authority notification, effectiveness verification.
Adverse-event cluster
AE signal in a recently launched product. Pharmacovigilance triage, FDA 15-day expedited reporting clock, TGA pharmacovigilance reporting under the Australian Requirements, periodic safety report implications, cross-region notification.
Counterfeit detection in legitimate supply
Suspect product surfaces in distribution. DSCSA response (US), TGA market action and ARTG-listing review (AU), EU FMD response, supplier qualification review, regulator notification.
Your clients are preparing for the inspector. Make sure the exercise evidence is ready too.
Inspection-readiness engagements cover SOPs, training records and deviation history. The one thing most clients arrive without is a dated, named exercise record showing their recall and CAPA processes were tested under pressure. Handrails produces that evidence in a single session, in under 60 minutes, without disrupting the rest of your engagement.
Be the partner that makes inspection prep feel lighter for your clients.
Run your first pharma exercise this week.
Sign up, pick a scenario, invite the team. The report is ready before the session ends.