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In the highly regulated pharmaceutical industry, inspections by the FDA and other global regulatory bodies are critical moments that assess an organization’s compliance with Good Manufacturing Practices (GMPs) and other regulatory frameworks. Successfully hosting these inspections requires meticulous preparation, thorough documentation, and an unwavering commitment to quality.
At PSC Software, with over 15 years of experience developing inspection management software, we understand the complexities of regulatory inspections. In this article, we’ll explore the essential criteria for inspection readiness and management, and demonstrate how ACE Inspection is the most comprehensive and effective software solution available for managing every stage of the inspection lifecycle.
Inspectors closely evaluate the suitability, cleanliness, and maintenance of facilities and equipment. This includes reviewing environmental controls, calibration records, and adherence to GMP standards.
ACE Inspection enables you to document and maintain detailed records of your facility’s qualifications, environmental monitoring logs, and equipment calibration. This ensures that you can present a clear and organized overview of your operational environment during inspections through core features available in the ACE platform.
Documentation is a cornerstone of regulatory inspections. Accurate, complete, and readily accessible records are critical. This includes:
ACE Inspection offers seamless integration with the document management system built into the ACE platform, ACE Docs, ensuring all necessary records are at your fingertips. Its powerful search functionality and real-time updates eliminate the risk of missing or outdated documents. Alternatively, attach or link documents from your existing document management system.
Inspectors often interact with staff to assess their understanding of and adherence to SOPs. Comprehensive training programs and mock inspections are critical to prepare your team for these interactions.
With ACE Inspection, you can track and document staff training and readiness with ACE LMS. Additionally, the ACE platform enables scheduling and recording mock inspections, assigning training tasks, and monitoring completion, ensuring your team is confident and prepared.
The inspection room—or “war room”—serves as the hub during the inspection. It requires flawless organization to manage requests efficiently and provide accurate responses promptly.
ACE Inspection’s real-time communication and request tracking tools optimize the flow of information between the inspection room and backroom. The platform’s Scribe Notes functionality is a standout feature, enabling the team to document live updates, track requests, and share critical information in real-time. This ensures that everyone involved is informed of the inspection’s progress, reducing delays and minimizing miscommunication.
Post-inspection, addressing findings promptly and effectively is critical. Corrective and Preventive Actions (CAPAs) must be initiated, tracked, and documented to resolve any issues identified during the inspection.
ACE Inspection simplifies CAPA management with its integrated tools in the ACE platform for assigning responsibilities, setting deadlines, and tracking progress. Its automated workflows ensure no finding goes unaddressed and facilitate a thorough root cause analysis.
Every inspection is an opportunity to improve. Post-inspection reviews should evaluate what went well, identify gaps, and implement lessons learned to enhance future readiness.
ACE Inspection’s analytics and reporting capabilities provide actionable insights into your performance. These tools help you identify trends, evaluate team readiness, and refine your processes to meet and exceed regulatory expectations.
ACE Inspection is designed for organizations of all sizes, offering unmatched flexibility and scalability. Its user-friendly interface and robust features allow you to manage inspections with confidence, from preparation to post-inspection analysis.
With over 15 years of industry experience developing inspection management software, PSC Software has developed ACE Inspection to meet the unique challenges of the life sciences industry. Our software is continuously updated to align with evolving regulatory requirements, ensuring you stay ahead of the curve.
Effective inspection management is vital for maintaining compliance and building trust with regulatory agencies. By investing in a robust inspection management system like ACE Inspection, you can ensure your organization is always inspection-ready. From preparation to post-inspection activities, ACE Inspection provides the tools and support you need to excel.
With PSC Software’s extensive experience and commitment to quality, ACE Inspection is the industry’s most comprehensive solution for managing inspections. Equip your team with the best tools available and turn inspections into opportunities for continuous improvement and organizational excellence.
For more information on ACE Inspection, contact us today.
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