From backlog to control
We support the full investigation and CAPA process, from intake and triage of deviations, complaints and audit or inspection findings to root cause analysis, action planning, execution support and effectiveness review. When a backlog has built up, we help you bring it under control, and build the maturity to keep it that way.
The challenge
Overdue investigations and CAPAs are among the most cited observations during regulatory inspections. Root cause investigations and CAPAs typically come on top of the daily workload of manufacturing personnel, which makes them a recurring compliance risk across the industry. A growing backlog rarely remains an internal quality issue. When inspectors arrive, it is often the first sign that a quality system needs closer attention, and it undermines an organization's ability to defend its records.
Warning signs
Our services
Our focus is on CAPA effectiveness rather than CAPA closure: reducing the backlog without compromising investigation quality, and making sure every action actually addresses its root cause.
Hands-on support across the full process: intake and triage of deviations, complaints and audit or inspection findings, investigation and root cause analysis, action planning, execution support and effectiveness review. Our experts are matched to the technical issue, with on-site support where needed.
A remediation plan to prioritize and coordinate the completion of open investigations and CAPAs: from backlog inventory and risk-based triage to segmentation and a structured recovery plan.
A compliance and quality improvement program that strengthens the ongoing control of investigations and CAPAs, so the backlog is less likely to build up again.
Our approach
Backlog inventory and data clean-up, and risk-based triage based on:
Segmentation of open records, an investigation quality review and a CAPA recovery plan that reduces the backlog without compromising quality. Open records are segmented into:
Structural changes to keep control: improved event classification, extension controls, CAPA effectiveness criteria and management dashboards, plus root cause investigation and writing training for your teams.
A mock inspection verifies that you can defend your records.
Upcoming webinar
A practical framework to regain control of your CAPA backlog
With Björn Aalbers, Monique Eilander and Bas Michielsen
Your partner
With a 20+ year track record as an investigation and CAPA partner, QbD Group is a preferred supplier for Top 20 Pharma and MedTech companies.
Partner with usInvestigation and CAPA experts matched to the technical issue, with on-site support where needed.
Relevant QA and specialist expertise for deviations, complaints and audit or inspection findings.
Built on hands-on experience supporting organizations through remediation and inspection preparation.
On-site or remote delivery, with a quick response when a backlog or an inspection creates urgency.
Whether you need QMS setup, audits, or ongoing compliance support, our QA experts are ready to help.
