Sierra QMS

Sierra QMS

Sierra Labs
+
+

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About

KeyDocs is a cloud-based document control and lifecycle management platform that extends Microsoft SharePoint and Microsoft 365. It helps organisations manage policies, procedures, forms and technical documents through drafting, review, approval, publishing and archival workflows. Teams can apply metadata and permissions, schedule reviews, issue alerts, publish approved documents, and maintain version histories and audit trails. Search and reporting help users locate current information and monitor ownership and review status. KeyDocs also provides mobile access, including offline access to published documents on iOS and iPadOS. Plans support smaller teams through enterprise deployments, with options for industry taxonomies, advanced metadata, integrations and support. It is aimed at compliance, risk, operations, quality, HSE and document-control teams managing governed information in regulated and operational industries.

About

Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device. Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports. As you scale and improve your workflows, policies and procedures, keep your team trained automatically. Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals. Generate all your policies, procedures, and artifacts into traditional documents for audit review.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Risk, compliance, operations, IT, document-control, quality and HSE leaders in organizations managing governed documents, especially in mining, utilities, infrastructure, manufacturing, construction, government, healthcare and financial services.

Audience

Organizations in need of a healthcare and life science Quality Management system

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

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.
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Company Information

KeyDocs
Founded: 2024
Australia
www.keydocs.com

Company Information

Sierra Labs
United States
www.sierralabs.com/quality-management/

Alternatives

Alternatives

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KOŚA
Xoralia

Xoralia

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QT9 QMS

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Total Lean Management (TLM) Software

Total Lean Management (TLM) Software

Lean & Mean Business Systems

Categories

Document Control Supported

Categories

CAPA Supported
Compliance Supported
Document Control Supported
Quality Management Supported
Risk Management Supported

Document Control Features

Archiving & Retention Supported
Automated Routing Supported
Change Management Supported
Compliance Management Supported
Electronic Signature Supported
Escalation Management Not Supported
Periodic Review Supported
Version Control Supported

CAPA Features

Audit Management Supported
CAPA Planning Not Supported
Change Management Supported
Complaint Management Supported
Incident Management Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Root Cause Analysis Supported
Training Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Not Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Not Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Supported
Risk Management Not Supported
Sarbanes-Oxley Compliance Supported
Surveys & Feedback Supported
Version Control Supported
Workflow / Process Automation Supported

Document Version Control Features

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

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Not Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Risk Management Features

Alerts/Notifications Supported
Auditing Not Supported
Business Process Control Supported
Compliance Management Supported
Corrective Actions (CAPA) Supported
Dashboard Not Supported
Exceptions Management Supported
Internal Controls Management Supported
IT Risk Management Supported
Legal Risk Management Not Supported
Mobile Access Supported
Operational Risk Management Supported
Predictive Analytics Supported
Reputation Risk Management Not Supported
Response Management Supported
Risk Assessment Supported

Integrations

Microsoft SharePoint Supported
Microsoft Teams Supported

Integrations

Microsoft SharePoint Not Supported
Microsoft Teams Not Supported
Claim KeyDocs and update features and information
Claim KeyDocs and update features and information
Claim Sierra QMS and update features and information
Claim Sierra QMS and update features and information