We provide rapid access to dedicated quality event management specialists who work exclusively for your organization on a contract basis. These professionals integrate directly into your quality team—investigating deviations, developing corrective actions, and implementing preventive measures while operating within your systems and processes.
Unlike traditional consultants who provide periodic support, our contracted specialists focus exclusively on your quality events day-to-day, rapidly resolving backlogs and implementing sustainable improvements. This model delivers specialized investigation expertise exactly when you need it, without the recruitment delays or long-term financial commitment of permanent hires.
Our specialists understand the complexities of quality event management and have backgrounds implementing and optimizing CAPA systems at organizations ranging from startups to multinational corporations. Many have experience addressing significant backlogs, implementing electronic systems, and developing sustainable processes that satisfy regulatory requirements while promoting operational efficiency.
When facing significant deviation backlogs, our staff augmentation model allows you to bring in one or multiple CAPA specialists simultaneously for rapid remediation, then scale back as the backlog diminishes—avoiding the inefficiency of maintaining permanent staff for fluctuating workloads.
Rather than hiring generalists who handle all deviations, our model enables you to engage specialists with experience investigating your specific types of quality events—whether sterility excursions, software issues, or manufacturing deviations.
Unlike fixed headcount models that struggle with unpredictable investigation workloads, staff augmentation allows you to adjust resources in real-time as simple deviations are cleared and complex investigations require more attention.
Our contracted CAPA specialists don't just process deviations—they implement improved investigation techniques and root cause analysis approaches that elevate your permanent team's capabilities for sustained performance improvement.
Our CAPA and deviation staff augmentation solutions are ideal during backlog situations when you need to rapidly process accumulated investigations without disrupting your core quality operations. They're equally valuable for implementing new CAPA systems, providing dedicated expertise to design and optimize quality event management processes. During post-inspection remediation, our specialists help address CAPA-related observations quickly and effectively.
For teams experiencing increased event volumes due to production expansion or new product introductions, our resources manage the surge without requiring permanent headcount increases. Also, when managing high-impact investigations, our professionals bring specialized root cause analysis expertise to resolve complex quality events while your permanent team maintains routine activities.
The FDA Group helped a multinational pharmaceutical company eliminate its deviation and CAPA backlogs while implementing systemic quality improvements. Our team of 17 specialists tackled remediation activities, provided staff training, and ensured continuity of improvements across their QMS. The project was completed on time and under budget, restoring the company's compliance status without disrupting operations.
Learn how The FDA Group partnered with a large clinical service company to manage its QMS remediation efforts and fulfill long-term staffing assignments for two vital roles in the management of the company’s quality and pharmacovigilance functions. This case study demonstrates the value of our convenient, cost-effective staff augmentation model as a means of circumventing the administrative costs and burdens of traditional hiring.
