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What is Sierra QMS?

Workflows are meticulously designed to aid in the preparation of all essential elements needed for a 510(k) submission, while also guaranteeing adherence to the quality record standards outlined in 21 CFR Part 820 as you get ready to launch your device. These workflows are equipped with tools that simplify the creation of vital policies, procedures, and work instructions. In addition, you can keep track of non-conformances, deviations, and CAPAs with custom quality management reports. As your processes develop and improve, automatic training updates ensure your team remains informed. The system also streamlines validation testing for devices, applications, websites, and bespoke software tailored to meet your business requirements. This automation greatly diminishes the time and resources typically needed for comprehensive testing, reporting, and approval tasks. Moreover, you can consolidate all your policies, procedures, and artifacts into standardized documents, making them easily accessible for audit assessments. This solution not only simplifies compliance and validation procedures but also significantly boosts operational efficiency. By integrating such advanced workflows, organizations can enhance their overall productivity and adaptability in a competitive market.

What is DocBridge Delta?

Assess and contrast complex documents using a fully reliable automated system, irrespective of the files' format or structure. It is essential to eliminate mistakes in the creation and distribution of documents, as these errors can result in considerable losses in time, money, and reputation. DocBridge Delta® offers a specialized module for analyzing print files across diverse formats like AFP, PDF, and PCL, which facilitates a smooth production workflow. In the current business climate, personalized customer communication is vital for success. Thanks to the functionalities of DocBridge Delta®, navigating complexity becomes achievable. Protecting your brand’s identity is essential for enduring success in the market. The sophisticated testing methods used by DocBridge Delta® can help prevent harmful deviations that might negatively impact your brand. By adopting automated quality assurance, companies can quickly realize benefits by minimizing expensive reprints. A prominent global printing firm emphasizes that they never produce a single page without processing it through Delta, underscoring the tool's significance within their production process. In conclusion, utilizing such technology not only improves quality but also strengthens the trust consumers have in your brand, ultimately contributing to its long-term viability. This commitment to excellence fosters a reputation that can set your business apart in a competitive landscape.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Sierra Labs

Company Location

United States

Company Website

www.sierralabs.com/quality-management/

Company Facts

Organization Name

Compart AG

Date Founded

1992

Company Location

Germany

Company Website

www.compart.com/en/docbridge-delta-document-qa-software

Categories and 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

Categories and Features

Document Control

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

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