ACE eQMS

ACE eQMS is a cloud-based electronic Quality Management System developed by PSC Software, designed for life sciences and other regulated industries. It supports quality, compliance, document, training, and operational process management within a single configurable platform, and is built to meet regulatory requirements including FDA 21 CFR Part 11, ISO 27001:2022, GDPR, and SOC 2.

ACE is available in three tiers — Starter, Essentials, and Enterprise — each offering increasing levels of workflow configuration, management modules, and compliance features. The platform targets organizations ranging from small businesses establishing foundational quality processes to large enterprises requiring fully configurable, validated workflows across multiple business functions.

Core Platform Features

• Configurable Workflows and Forms: Users can design and configure workflows and forms to match their organization's specific quality and compliance requirements, supporting task organization, collaboration, and accountability while reducing manual errors.
• Advanced Permissions Management: Fully configurable role-based permissions control which users can access, edit, or view specific data and workflows, supporting data security and compliance with regulatory standards.
• Enterprise Reporting and Analytics: Real-time dashboards and customizable reports allow users to monitor key performance indicators, track process efficiency, and identify areas for improvement. Reports can be exported in PDF and Word formats using configurable templates.
• Record Filters: Users can filter record lists by assigned user, status, or date range, and save and share custom filters across teams for consistent visibility into workflows.
• Project Boards: Kanban-style project boards provide visual task and record management, supporting progress tracking, task assignment, and deadline monitoring across workflows.
• 21 CFR Part 11 Compliance: ACE includes secure electronic signatures, audit trails, and version control to support FDA and global regulatory compliance and inspection readiness.
• Audit Trails: All actions — including changes to workflows, forms, and records — are automatically recorded with time-stamped logs to support compliance audits and organizational accountability.
• Real-Time Notifications: Automated notifications alert users to tasks, approvals, and overdue actions to support deadline management.
• Mobile Accessibility: A mobile-optimized interface allows users to access ACE from any device to manage tasks, review workflows, and track progress.
• AI Assistant: ACE Intelligence integrates a Generative AI assistant to support data analysis and decision-making across all plan tiers.
• Advanced Data Encryption: ACE Shield, available on the Enterprise tier, provides data encryption and event monitoring to protect sensitive information. The platform supports AES 256-bit encryption for data at rest and in transit.

Management Modules by Plan

• Document Management: Available across all tiers; supports dynamic document editing through Office 365 integration and permission-based access controls.
• Training Management: Available across all tiers; supports building training programs for processes, policies, and procedures, with automated retraining schedules.
• Quality Management: Available on Essentials and Enterprise tiers; covers deviations, corrective and preventive actions (CAPA), change controls, action items, and electronic signature-based approvals.
• Asset Management: Available on Essentials and Enterprise tiers; provides centralized tracking, maintenance, and lifecycle management of assets.
• Audit Management: Available on Essentials and Enterprise tiers; supports audit scheduling, customizable audit checklists, vendor/supplier distribution, report generation, and findings remediation follow-up.
• Supplier Management: Available on Essentials and Enterprise tiers; covers supplier risk assessments, vendor performance evaluations, and centralized supplier documentation.
• Inspection Management: Available on the Enterprise tier; supports inspection readiness through trend analysis, citation data review, scribe notes, request tracking, and daily summary notes for remote and in-person inspections.
• Risk-based Vendor Assessments: Available on the Enterprise tier; includes automatically scored assessments and a drillable risk assessment dashboard.
• Risk Management: Available on the Enterprise tier; supports custom risk matrices, Critical Control Point (CCP) identification, and Failure Mode and Effects Analysis (FMEA).
• Digital Signature Management: Available on the Enterprise tier via ACE Sign™; provides a secure digital signature solution for document approvals.
• Paperless Validation: Available on the Enterprise tier; supports digital creation and execution of validation test plans and cases with review, approval, and audit trails.
• Electronic Batch Management: Available on the Enterprise tier; covers documentation and verification of batch manufacturing steps, with libraries for batch status stages and Review by Exception workflows.
• Clinical Trial Management: Available on the Enterprise tier; supports milestone setting, document tracking, and progress monitoring via an ACE Clinical dashboard.

Validation and Compliance

• Each ACE release undergoes Installation Qualification (IQ) and Operational Qualification (OQ) validation, with a validation package provided to reduce customer validation workload.
• Pre-configured workflows on all tiers are pre-validated to IQ/OQ/PQ standards and maintained by PSC Software across software releases.
• The Enterprise tier offers custom revalidation through ACE Evergreen.
• ACE is ISO 27001:2022 compliant and meets GDPR and SOC 2 standards.

Use Cases Supported

• Quality Management: Automating and managing quality processes in regulated industries including life sciences.
• Audit Management: Scheduling audits, tracking findings, and maintaining regulatory compliance.
• Human Resources: Managing onboarding documentation, training schedules, and compliance requirements for new hires.
• Supply Chain: Tracking inventory, managing supplier relationships, and forecasting demand.
• Finance: Automating invoice processing to reduce manual errors and support timely vendor payments.
• Sales: Tracking and managing leads through the sales pipeline.

Integrations and Enterprise Capabilities

• ACE supports Single Sign-On (SSO) for user authentication across the organization.
• Integration with electronic signature systems enables document approvals directly within the platform.
• Office 365 integration supports dynamic document editing within the Document Management module.
• An API and native integrations allow ACE to connect with other organizational tools.

PSC Software provides onboarding support and dedicated customer support specialists for ACE implementations. The platform is used across a range of organizations in life sciences and other regulated industries, with deployment as a cloud-based SaaS solution.