5 Ways ACE Inspection Keeps You Audit-Ready

We frequently hear from customers about the challenges they face during inspections and audits, especially in highly regulated industries like pharmaceuticals, biotech, and medical devices. Legacy systems often fall short in providing the agility, traceability, and compliance support needed to meet evolving regulatory expectations. That’s why we developed ACE Inspection, a purpose-built module within the ACE platform designed to streamline inspection readiness and execution. Here are the top ways ACE Inspection helps organizations stay audit-ready and inspection-resilient—with real-world examples. 

Top 5 Ways ACE Inspection Helps Regulated Industries

1. Centralized Inspection Request Management

Challenge: Inspection requests often come from multiple sources, from regulatory bodies like the FDA and the EMA, to internal QA teams, and managing them manually leads to delays and confusion. 

How ACE Helps: ACE Inspection can centralize all inspection-related activities in one accessible dashboard. As an example, for FDA audits at pharmaceutical companies, ACE Inspection can be used to track multiple inspection requests in real time and visualized on the dashboard. Each request can be assigned, prioritized, and resolved within the platform, which drastically reduces response time. 

2. Real-Time Scribe and Documentation Support

Challenge: Capturing accurate notes during inspections is critical, but manual note-taking can lead to errors, gaps, and miscommunication. 

How ACE Helps: ACE Inspection’s real-time scribe feature allows teams to log inspector questions, responses, and observations instantly. In one case, a biotech firm undergoing a remote inspection used ACE’s scribe notes to document interactions across three departments. These notes were immediately accessible to all stakeholders, ensuring alignment and reducing post-inspection follow-up time.

3. Automated Notifications and Task Assignments

Challenge: Coordinating across departments during inspections is difficult, especially when requests are time-sensitive. 

How ACE Helps: ACE Inspection automates notifications and task assignments. For instance, during a mock inspection at a pharma company, ACE automatically notified document requests to the assigned appropriate SMEs, who received alerts and uploaded responses within minutes. This helped the company avoid delays and demonstrated effective operational control to the inspector. 

4. Integration with Analytical Module and eQMS

Challenge: Inspectors often ask for data that spans multiple systems, including quality records like CAPAs and audit logs, as well as training records, which can be hard to compile quickly with a manual system. 

How ACE Helps: ACE Inspection integrates with ACE Analytics and ACE eQMS, allowing instant access to quality documentation and in-depth analysis. This integration can be used to present real-time CAPA trends and training compliance metrics during a regulatory inspection. Through ACE Inspection, the inspector can be granted secure, read-only access to the ACE platform. 

5. Post-Inspection Follow-Up and CAPA Management

Challenge: After an inspection, organizations often struggle to track and close out findings, especially when multiple CAPAs are involved across departments. Manual tracking can lead to missed deadlines, inconsistent documentation, and repeat observations in future audits. 

How ACE Helps: ACE Inspection simplifies post-inspection follow-up by linking inspection findings directly to CAPA workflows within the ACE eQMS. Take for example, a pharmaceutical company undergoing a multi-day inspection used ACE Inspection to log 15 observations. A CAPA was created for each observation, assigned to the appropriate owner, and tracked through resolution. The system can show the CAPA record’s real-time status and this was used along with personalized notifications to ensure that all documentation was audit-ready for the inspector’s follow-up visit. This closed-loop process not only improves accountability and responsiveness but also reduces the risk of recurring issues. 

Conclusion 

ACE Inspection empowers regulated organizations to transform their inspection and audit processes from reactive to proactive. By centralizing data, automating workflows, and integrating with other ACE modules, it ensures that teams are always prepared, whether for a scheduled audit or a surprise inspection. If you’re looking to modernize your inspection management approach, reach out to learn how ACE Inspection can support your compliance and operational goals.