ACE Features
Operations (4)
Data Management
Collects and stores patient and company data in a centralized database
Multichannel Engagement
Analyzes and maintains patient-provider interactions across multiple touchpoints to optimize customer interactions
Task Automation
Automates and streamlines tasks, integrations, communication, and personalization
Industry Regulations
Ensures that sales teams, health care organizations, and field service reps adhere to industry regulations
Quality Management (3)
Design Controls
Ensures that the product development process stays on track and continues to meet both user and vendor needs
Audit Management
Prepares for, plans, manages, schedules, and conducts internal and external audits
Risk Management
Reviews, identifies, and assesses sources of risk in research and development
Quality System (4)
Analytics & Reporting
Collects both vendor- and customer-facing data relevant to the product development lifecycle, and generates performance and health reports
Real-time Collaboration
Enables real-time collaboration like automated notifications and rich editing and commenting capabilities to minimize miscommunication
Document Control
Automates, centralizes, and archives documents and forms to create a single source of truth
Quality Processes
Automates and manages processes like CAPA (Corrective and Preventive Action) to monitor quality and complaints and promote transparency
Nonconformance (3)
Conformance Records
Allows users to create, track and maintain accurate, auditable conformance records.
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CAPA
Allows users to assign tasks for corrective and preventive actions (CAPA) to employees in nonconformance
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Change Management
Allows users to submit change requests and control plan revisions at any point in the production process and track all revisions.
Quality system (3)
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Document Control
Allow users to centralize and archive documents for quality management
Collaboration
Allows users to collaborate in real time with editing and commenting capabilities to minimize miscommunication
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Analytics and Reports
Allows users to collects both vendor- and customer-facing data relevant to the product development lifecycle, and generates performance and health reports
Risk Management (3)
Assessments
Allows users to determine potential risks that may impact employees or the environment
Operational Risk
Allows users to estimate the impact of EHS risks on the operations of the company
Supplier Evaluation
Allows users to evaluate suppliers using safety and environmental criteria
Inspection Management (3)
Templates
Allows users to choose from templates for multiple types of inspections such as safety or quality
Workflows
Provides users with workflows to assign tasks for audit and inspections
Corrective Actions
Allows users to identify corrective actions to address incidents and accidents
Compliance (3)
Standards & Regulations
Provides users with regulations to follow under the Occupational Safety and Health Act (OSHA)
Permits
Allows users to track permits required for environmental and safety compliance
Certifications
Allows users to manage certifications to comply with regulations and standards
Activity Management (5)
Product-To-Market Management
Accelerates time to market while reducing risk of medtech products and devices.
Regulatory Adherence
Ensures regulation compliance via notifications and triggers of noncompliant processes.
Information Management
Collects and manages product, operations, and activity information.
Process Automation
Automates the collection and management of data and business processes.
Sales Management
Optimizes the activities of field sales / medical representatives before, during, and after the sales cycle.
Platform (4)
Integration
Delivers APIs and standard integrations with other software systems.
Security & Privacy
Complies with security and privacy regulations and standards.
Mobile Access
Allows users to access the software using mobile devices.
Flexibility
Facilitates software configuration without the need for technical experise.
Services (4)
Implementation
Assists customes through all the phases of the implementation process.
Training & Learning
Provides software users with training courses and learning content.
Customer Support
Delivers customer and technical support, directly or trough partners.
Professional Services
The vendor provides consulting services such as business process reengineering.
Execution (5)
Sampling
Identify and track material samples for inspection or re-inspection.
Corrective Actions
Implement action plans which can be prioritized based on severity.
Data Capture
Capture inspection data including photos and video, both online and offline.
Reports
Generate inspection reports using the information gathered during the inspection.
Ad-hoc Tasks
Allow users to create ad-hoc or unplanned inspection tasks.
Planning (4)
Checklists
Ability to create configurable forms and checklists to capture inspection information.
Approvals
Ability to define criteria and workflows to approve or reject inspection tasks.
Scheduling
Organize inspection tasks based on constraints such as inspector availability.
Procedures
Allow users to create procedures and workflows for multiple types of inspections.
Analytics (5)
Monitoring
Track the inspection process to ensure it follows procedures and complies with regulations.
KPIs
Analyze inspection metrics such as cost of quality or Overall Operations Effectiveness (OOE).
Nonconformace
Generate nonconformance records and reports for defective products or noncompliance.
Reporting
Provide users with the ability to report progress made throughout the product lifecycle.
Costing
Track product costs and costs related to design and development activities
Regulatory Compliance (4)
Dashboards and Reporting
Offers customizable dashboards and analytics to track completeness, compliance, quality, and timeliness of the study.
TMF Reference Models
Offers a pre-built DIA TMF reference model hierarchy, and allows for configurable reference models to meet the specific needs of organizations and sponsors.
Inspection Readiness
Supports inspections and regulatory audits by maintaining inventory and document reports, and having pre-built compliance with all relevant regulatory guidelines.
Role Permissions
Designates customizable user roles and limit access to certain functions in the eTMF.
Content Management (7)
Bulk Upload and Indexing
Allows users to upload multiple documents at once and provides dynamic indexing options.
Document Tracking
Manages the status of all trial documentation at all stages and flags missing documentation.
Version Controlling
Tracks each version of a document and shows changes from each version or reupload.
Search Engine
Allows documents and metadata to be easily searched within the system.
File Planning and Milestones
Establishes study level, country level, and site level milestones and what amount of mandatory and optional documents need to be collected throughout the study lifecycle.
Real-Time Authoring and Collaboration
Allows external or remote contributors to upload documents and work collaboratively in a controlled method.
Content Workflows
Configures review, e-signature, and approval workflows for all documentation.
New Product Introduction (2)
Ideation
Gather and analyse ideas for new products or product enhancements
Product approval
Deliver workflows that can be used by managers to approve or reject new products and features
CAD (1)
CAD Models
Allows users to create new CAD models or import them from CAD systems
Collaboration (1)
Document Management
Allows user to collaborate on creating and managing documents and files
Product Data Management (3)
Product Metadata
Define and manage a taxonomy of product metadata that applies to the entire company
Data Quality
Manages the quality of the product data and ensures its up to date
Version Control
Tracks and audits versions and changes, including options to check-in and check-out
Bill of Materials (2)
BOM management
Provide the ability to deliver product variations such as configure-to-order and engineer-to-order
Multi-level BOM
Bills of materials can be combined, merged, and nested to create multi-level BOMs
Engineering Change Management (3)
ECR Workflows
Deliver workflows to approve or reject engineering change requests (ECR)
Change Management
Allows user to manage changes to product configurations while maintaining the functional and physical attributes of a product throughout its lifecycle.
ECO Management
Create and manage engineering change orders (ECO) based on ECRs or from scratch
Quality management (3)
Quality planning
Provide users with the ability to identify all functional needs of the product ahead of time and incorporate this information into each stage in the product development lifecycle
Traceability
Ensures that all quality issues can be traced back to the root causes
Compliance
Ensures compliance of items according to regulatory, safety, and environmental specifications
Integration (4)
ERP
Integrates with manufacturing ERP solutions
MES
Integrates with Manufacturing Execution Systems (MES)
PIM
Integrates with Product Information Management (PIM) software
Maintenance
Integrates with software for maintenance such as Enterprise Resource Management (EAM)
Generative AI (2)
AI Text Summarization
Condenses long documents or text into a brief summary.
AI Image-to-Text
Converts images into a textual description, identifying key elements.





