ACE Inspection

ACE Inspection is an inspection audit management software developed by PSC Software, designed for life sciences and regulated industries managing GxP, quality, FDA, and other regulatory inspections. The platform centralises inspection request tracking, team communication, document sharing, and reporting in a single system, helping organisations maintain audit readiness and meet compliance requirements.

ACE Inspection is available in two packages: the full-featured ACE Inspection tier and AuditUtopia Powered by ACE, a starter option covering core inspection management functionality. The full tier adds capabilities such as the Inspector File Sharing Portal, ACE Regulatory Profiles, post-inspection issue closure, and API access.

Inspection and Request Management

• Tracks every inspection request with detailed oversight of assignees, priority levels, and request statuses.
• Supports customisable fields to capture specific information relevant to each inspection.
• Provides a central request list with filtering options — users can sort by assignee, unresolved status, date range, and other criteria, and save and share filters organisation-wide.
• Project boards offer a continuously synchronised, customisable view of all request statuses within an active inspection.
• Every action is recorded and time-stamped, maintaining a comprehensive log for accountability and post-inspection review.
• Site management functionality allows teams to add and manage multiple inspection sites, supporting FDA and other regulatory inspection preparation.
• Accessible from any browser or mobile device (iOS and Android).

Communication Features

• Scribe Notes allow inspection teams to capture detailed, real-time activity logs during inspections. Notes are visible to all team members as they are typed, and can be linked to specific inspection requests and tagged for organisation.
• Scribe Notes support full search and export capabilities for post-inspection review, and access is permission-controlled.
• Group and private chat rooms are automatically created for each inspection with appropriate team permission levels. Conversations are saved with timestamps, and file transfer is supported within chat.
• Request Comments allow team members to start threads or reply to existing comments within a request, enabling organised communication around specific inspection queries.
• In-system and email notifications are configurable by action, recipient, group, or email address, ensuring relevant personnel are informed of updates, new messages, or schedule changes in real time.

Inspector Portal and Document Sharing

• A built-in Inspector File Sharing Portal allows users to securely share documents with inspectors during an inspection.
• Tracks file access analytics including file opening and download actions, with configurable download permissions.
• Integrates with Box to extend sharing functionality to portals used by the FDA, supporting remote inspection management.
• Inspectors can access documentation directly within their own Box environment.

ACE Regulatory Profiles

• An AI-powered database of regulatory inspector information, including citation trends and Form 483 details.
• Allows inspection teams to research FDA inspectors and understand their focus areas and inspection priorities.
• Supports proactive compliance management and inspection readiness by helping teams anticipate likely inspection areas.

Reporting and Analytics

• Includes the ACE Analytics module for tracking and measuring inspection statistics and performance in real time.
• Pre-built metric reports cover request workloads, time spent in specific statuses, and assignee performance.
• Configurable reports can be adapted using familiar tools such as Microsoft Word, and request data is fully exportable in Word, Excel, or PDF format.
• Inspection Performance Reports show how many requests were opened, resolved, or closed, and track status duration regardless of assignee.
• Request Reports can be saved and pinned to dashboards for real-time statistics on request volume and performance.

Post-Inspection Issue Closure

• Available in the full ACE Inspection tier, this feature provides a workflow-driven system for managing and resolving post-inspection findings.
• Tracks corrective actions, ensures accountability, and supports timely issue closure to facilitate continuous quality improvement.

ACE Inspection supports Single Sign-On (SSO) via any SAML 2.0 authentication provider, including Azure Active Directory, Okta, and Google. API access is available in the full tier for integration with other business applications. The platform is used by organisations in regulated industries including pharmaceutical and life sciences companies.