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Description
Assai's Document Management system (DMS or eDMS) is designed to help you easily store, manage, and access all of your important documents and information in one central, easily searchable repository. Whether you're looking for documents, drawings, correspondence, emails, contracts, or purchase orders, our system allows you to quickly find what you need using comprehensive search options on metadata and content.
One of the key benefits of our DMS is that you have complete control over access to your documents and information. This means that you can easily manage who has access to what, ensuring that your team always has the latest versions of the documents they need.
In addition to providing a central repository for your documents and information, Assai's Document Control system also allows you to streamline and control workflows. With our system, you can easily set up and maintain workflows, making use of user inboxes, automatic workflow assignments, and forwarding.
And with our Enterprise Content Management capabilities, we're able to support even the most complex projects and operations. Get a grip on your projects, assets, documents and data with our Common Data Environment.
Description
Workflows are specifically developed to assist you in preparing all necessary components for a 510(k) submission, while also ensuring compliance with the quality record requirements set forth in 21 CFR Part 820 as you prepare to market your device. These workflows come equipped with tools to facilitate the drafting of essential policies, procedures, and work instructions. Furthermore, you can monitor non-conformances, deviations, and CAPAs through tailored quality management reports. As your processes evolve and enhance, you can ensure your team receives automatic training updates. The system also automates validation testing for devices, applications, websites, and custom software tailored to your business needs. This automation significantly reduces the time and resources that would otherwise be consumed by extensive testing, reporting, and approval processes. Additionally, you can compile all your policies, procedures, and artifacts into standard documents, making them readily available for audit evaluations. Overall, this solution streamlines the compliance and validation processes, thereby enhancing operational efficiency.
API Access
Has API
Yes
API Access
Has API
No
Integrations
AVEVA Asset Information Management
Yes
CAESAR II
Yes
IBM FileNet Content Manager
Yes
Microsoft Entra ID
Yes
Microsoft Excel
Yes
Microsoft Power BI
Yes
Microsoft Project
Yes
Microsoft SharePoint
Yes
OpenText Documentum
Yes
Oracle Aconex
Yes
Integrations
AVEVA Asset Information Management
No
CAESAR II
No
IBM FileNet Content Manager
No
Microsoft Entra ID
No
Microsoft Excel
No
Microsoft Power BI
No
Microsoft Project
No
Microsoft SharePoint
No
OpenText Documentum
No
Oracle Aconex
No
Pricing Details
$5999/month
Pricing depends on the number and type of users/licences and the software modules included.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
No
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
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Assai Software Services
Founded
1990
Country
Netherlands
Website
www.assai-software.com
Vendor Details
Company Name
Sierra Labs
Country
United States
Website
www.sierralabs.com/quality-management/
Product Features
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
Enterprise Content Management (ECM)
Archiving & Retention
Yes
Collaboration Tools
Yes
Content Lifecycle Management
Yes
Digital Asset Management
Yes
Document Management
Yes
Electronic Signature
Yes
Information Governance
Yes
Mobile Access
Yes
Search
Yes
Version Control
Yes
Workflow Management
Yes
Product Features
CAPA
Audit Management
Yes
CAPA Planning
No
Change Management
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training Management
Yes
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
No
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
Yes
Risk Management
No
Sarbanes-Oxley Compliance
Yes
Surveys & Feedback
Yes
Version Control
Yes
Workflow / Process Automation
Yes
Document Control
Archiving & Retention
Yes
Automated Routing
Yes
Change Management
Yes
Compliance Management
Yes
Electronic Signature
Yes
Escalation Management
No
Periodic Review
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
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
No
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
No
Business Process Control
Yes
Compliance Management
Yes
Corrective Actions (CAPA)
Yes
Dashboard
No
Exceptions Management
Yes
IT Risk Management
Yes
Internal Controls Management
Yes
Legal Risk Management
No
Mobile Access
Yes
Operational Risk Management
Yes
Predictive Analytics
Yes
Reputation Risk Management
No
Response Management
Yes
Risk Assessment
Yes