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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 KeyDocs?

KeyDocs stands out as a pioneering cloud-based solution tailored for document control and lifecycle management, significantly augmenting the functionalities of Microsoft SharePoint and Microsoft 365. This platform allows organizations to proficiently manage their policies, procedures, forms, and technical documents through a structured workflow that encompasses drafting, reviewing, approving, publishing, and archiving stages. Teams can take advantage of various features, including the application of metadata, setting permissions, scheduling reviews, issuing alerts, publishing documents, and maintaining version histories along with comprehensive audit trails for meticulous oversight. With powerful search and reporting tools, users can swiftly locate current information while monitoring document ownership and the progress of reviews. Moreover, KeyDocs provides mobile access, enabling users to interact with published documents offline on both iOS and iPadOS devices. Serving a broad range of needs, it accommodates both small teams and large enterprises, offering customizable options for industry-specific taxonomies, advanced metadata, and integrations, in addition to dedicated support. Focused on enhancing compliance, risk management, operational efficiency, quality assurance, and health, safety, and environmental (HSE) initiatives, KeyDocs becomes an indispensable asset for document-control teams engaged with regulated information across various sectors. By leveraging this platform, organizations not only streamline their document management processes but also reinforce their commitment to compliance and operational excellence, thereby fostering a culture of proactive governance and accountability.

Media

Media

Integrations Supported

Integrations Supported

Microsoft SharePoint
Microsoft Teams

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

AUD 1,000/month
Starter starts at AUD 1,000 per month for up to 50 users, including up to 10 workflow users. Growth starts at AUD 3,000 per month for up to 500 users and 50 workflow users. Pro starts at AUD 4,000 per month for up to 2,000 users and 250 workflow users. Included features vary by plan.

Supported Platforms

SaaS

Supported Platforms

SaaS
iPhone
iPad

Customer Service / Support

Web-Based Support

Customer Service / Support

Not specified

Training Options

Documentation Hub

Training Options

Not specified

Company Facts

Organization Name

Sierra Labs

Company Location

United States

Company Website

www.sierralabs.com/quality-management/

Company Facts

Organization Name

KeyDocs

Date Founded

2024

Company Location

Australia

Company Website

www.keydocs.com

Categories and Features

CAPA

Audit Management
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Environmental Compliance
FDA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
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
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Risk Management

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

Categories and Features

Document Control

Not specified

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