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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
API Access
Has API
Integrations
AVEVA Asset Information Management
CAESAR II
IBM FileNet Content Manager
Microsoft Entra ID
Microsoft Excel
Microsoft Power BI
Microsoft Project
Microsoft SharePoint
OpenText Documentum
Oracle Aconex
Integrations
AVEVA Asset Information Management
CAESAR II
IBM FileNet Content Manager
Microsoft Entra ID
Microsoft Excel
Microsoft Power BI
Microsoft Project
Microsoft SharePoint
OpenText Documentum
Oracle Aconex
Pricing Details
$5999/month
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
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
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Document Management
Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control
Document Version Control
Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback
Enterprise Content Management (ECM)
Archiving & Retention
Collaboration Tools
Content Lifecycle Management
Digital Asset Management
Document Management
Electronic Signature
Information Governance
Mobile Access
Search
Version Control
Workflow Management
Product Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Document Version Control
Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Risk Management
Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment