Average Ratings 4 Ratings

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Description

Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant. Our one-stop software includes: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And so much more! Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform. ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.

Description

Orcanos is an integrated MedTech software platform built to help medical device companies manage quality, compliance, product development, and regulatory documentation from one connected workspace. It combines electronic quality management, application lifecycle management, design controls, document control, risk management, traceability, and audit readiness. The platform is designed to bridge the gap between R&D and Quality teams by connecting user needs, requirements, hazards, mitigations, tests, validations, complaints, and quality processes. Orcanos supports regulated frameworks and standards such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Its eQMS capabilities include document workflows, PDF publishing, revision control, electronic signatures, training automation, audit trails, CAPA support, and quality process management. ALM and design control features help teams maintain a live digital thread across development artifacts, risk files, verification activities, and design history documentation. Orcanos also offers customizable no-code workflows, configurable fields, granular permissions, and migration support for teams moving from spreadsheets or legacy tools. Its AI-powered assistant, Ask Paul, is positioned to help users navigate operations and improve efficiency. By unifying quality and development data, Orcanos helps medical device organizations stay audit-ready while reducing manual documentation work.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Microsoft 365 Yes 
Jira No 
SAP Access Control Yes 
Salesforce No 

Integrations

Microsoft 365 Yes 
Jira Yes 
SAP Access Control No 
Salesforce Yes 

Pricing Details

We are proud to be an affordable and trusting software provider. Our pricing varies depending on numerous factors such as number of licenses, length of contract and more. We would be happy to work out a plan that best fits your needs!
Free Trial Yes 
Free Version No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version Yes 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
Mac Yes 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App Yes 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

PSC Software

Founded

1996

Country

United States

Website

pscsoftware.com/software/ace/

Vendor Details

Company Name

Orcanos

Founded

2004

Country

Israel

Website

www.orcanos.com

Product Features

Asset Tracking

Activity Tracking Yes 
Audit Trails Yes 
Barcoding / RFID Yes 
Checkout / Check-In Yes 
Depreciation Tracking Yes 
Disposal Tracking Yes 
Inventory Management Yes 
Location Tracking Yes 
QR Codes Yes 
Reservations Yes 
Service History Yes 

Audit

Alerts / Notifications Yes 
Audit Planning Yes 
Compliance Management Yes 
Dashboard Yes 
Exceptions Management Yes 
Forms Management Yes 
Issue Management Yes 
Mobile Access Yes 
Multi-Year Planning Yes 
Risk Assessment Yes 
Workflow Management Yes 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing Yes 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance Yes 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance Yes 
Risk Management Yes 
Sarbanes-Oxley Compliance Yes 
Surveys & Feedback Yes 
Version Control Yes 
Workflow / Process Automation Yes 

Document Collaboration

Access Control / Permissions Yes 
Autosave Yes 
Chat / Messaging Yes 
Cloud Storage Yes 
Comments / Annotations Yes 
Edit / Change Tracking Yes 
Electronic Signature Yes 
Multiple File Formats Yes 
Pre-made Templates Yes 
Search Yes 
User Tagging Yes 
Version Control Yes 
Workflow / Approval Process Yes 

Document Control

Archiving & Retention Yes 
Automated Routing Yes 
Change Management Yes 
Compliance Management Yes 
Electronic Signature Yes 
Escalation Management Yes 
Periodic Review Yes 
Version Control Yes 

Document Management

Access Controls Yes 
Archiving & Retention Yes 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture Yes 
Document Conversion Yes 
Document Delivery Yes 
Document Indexing Yes 
Document Retention Yes 
Electronic Signature Yes 
Email Management Yes 
File Recovery Yes 
File Type Conversion Yes 
Forms Management Yes 
Full Text Search Yes 
Offline Access Yes 
Optical Character Recognition Yes 
Print Management Yes 
Version Control Yes 

Document Version Control

Access Controls/Permissions Yes 
Approval Process Control Yes 
Archiving & Retention Yes 
Audit Trail Yes 
Commenting / Notes Yes 
Document Check-in / Check-out Yes 
For Engineering Documents Yes 
Revision History Yes 
Version Comparison Yes 
Version Rollback Yes 

Fixed Asset Management

Asset Budgeting Yes 
Asset Lifecycle Management Yes 
Audit Trail Yes 
Barcoding / RFID Yes 
Depreciation Management Yes 
Disposal Management Yes 
Document Management Yes 
Inventory Tracking No 
Tax Management Yes 

Product Lifecycle Management

Change Management Yes 
Compliance Management Yes 
Cost Tracking Yes 
Design Management Yes 
Document Management Yes 
Product Data Management Yes 
Project Management Yes 
Requirements Management Yes 
Supplier Management Yes 

Product Management

Collaboration Yes 
Feedback Collection Yes 
Idea Management Yes 
Milestone Tracking Yes 
Prioritization Yes 
Product Roadmapping Yes 
Release Management Yes 
Requirements Management Yes 
Resource Management Yes 
Workflow Management Yes 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Risk Management

Alerts/Notifications Yes 
Auditing Yes 
Business Process Control Yes 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard Yes 
Exceptions Management Yes 
IT Risk Management Yes 
Internal Controls Management Yes 
Legal Risk Management Yes 
Mobile Access Yes 
Operational Risk Management Yes 
Predictive Analytics Yes 
Reputation Risk Management Yes 
Response Management Yes 
Risk Assessment Yes 

Software Documentation

Access Roles / User Permissions Yes 
Automatic Documentation Generation Yes 
Collaboration Tools Yes 
Docs Web Hosting Yes 
Feedback Capture Yes 
Markdown Support Yes 
Multiple Formats Support No 
Multiple Versions Support Yes 
Version Control Yes 
WYSIWIG Editor No 
Webhooks Yes 
reStructured Text Support Yes 

Training

Academic / Education Yes 
Asynchronous Learning Yes 
Blended Learning Yes 
Built-In Course Authoring Yes 
Built-in LMS Yes 
Certification Management Yes 
Corporate / Business Yes 
Learner Portal Yes 
Mobile Learning Yes 
Simulation Yes 
Synchronous Learning Yes 
Training Companies No 
eCommerce Yes 

Workflow Management

Access Controls/Permissions Yes 
Approval Process Control Yes 
Business Process Automation Yes 
Calendar Management Yes 
Compliance Tracking Yes 
Configurable Workflow Yes 
Customizable Dashboard Yes 
Document Management Yes 
Forms Management Yes 
Graphical Workflow Editor Yes 
Mobile Access Yes 
No-Code Yes 
Task Management Yes 
Third Party Integrations Yes 
Workflow Configuration Yes 

Product Features

Application Lifecycle Management

Administrator Level Control Yes 
Defect Tracking Yes 
Iteration Planning Yes 
Project Management Yes 
Release Management Yes 
Requirements Review Yes 
Task Management Yes 
Test Case Tracking Yes 
User Level Management Yes 
Version Control Yes 

Audit

Alerts / Notifications No 
Audit Planning No 
Compliance Management No 
Dashboard No 
Exceptions Management No 
Forms Management No 
Issue Management No 
Mobile Access No 
Multi-Year Planning No 
Risk Assessment No 
Workflow Management No 

CAPA

Audit Management No 
CAPA Planning No 
Change Management No 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management No 
Root Cause Analysis No 
Training Management No 

Compliance

Archiving & Retention No 
Artificial Intelligence (AI) No 
Audit Management No 
Compliance Tracking No 
Controls Testing No 
Environmental Compliance No 
FDA Compliance No 
HIPAA Compliance No 
ISO Compliance No 
Incident Management No 
OSHA Compliance No 
Risk Management No 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control No 
Workflow / Process Automation No 

Document Control

Archiving & Retention No 
Automated Routing No 
Change Management No 
Compliance Management No 
Electronic Signature No 
Escalation Management No 
Periodic Review No 
Version Control No 

Quality Management

Audit Management No 
Complaint Management No 
Compliance Management No 
Corrective and Preventive Actions (CAPA) No 
Defect Tracking No 
Document Control No 
Equipment Management No 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control No 
Training Management No 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA No 
Automated Test Generation No 
Automated Use Case Modeling No 
Change Management Yes 
Collaboration Yes 
History Tracking Yes 
Prioritization Yes 
Reporting Yes 
Status Reporting Yes 
Status Tracking Yes 
Summary Reports Yes 
Task Management Yes 
To-Do List Yes 
Traceability Yes 
User Defined Attributes Yes 

Risk Management

Alerts/Notifications No 
Auditing No 
Business Process Control No 
Compliance Management No 
Corrective Actions (CAPA) No 
Dashboard No 
Exceptions Management No 
IT Risk Management No 
Internal Controls Management No 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management No 
Predictive Analytics No 
Reputation Risk Management No 
Response Management No 
Risk Assessment No 

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