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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 CAPA Manager?

FREE CAPA SOFTWARE FOR 2 USERS — NO TIME LIMIT! CAPA Manager helps businesses improve quality, reduce recurring problems, and take control of corrective and preventive actions. Start instantly with a free two-user account. No credit card, setup fees, or sales calls required. Designed for aerospace, automotive, medical device, pharmaceutical, and manufacturing organizations, CAPA Manager brings investigations, root cause analysis, corrective actions, and management reporting together in one easy-to-use system. Features include 8D problem solving, configurable workflows, 5 Why and 6M analysis, automated action tracking, closure approvals, audit trails, dashboards, and reporting. Suitable for small businesses and growing enterprises, CAPA Manager helps teams improve accountability and maintain audit-ready records. Start free today!

Media

Media

Integrations Supported

Integrations Supported

EntraGUARD

API Availability

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

$18.21 per user/month
Start FREE with 2 users, forever! No credit card, setup fees, or time limits.
CAPA Manager offers flexible, affordable subscription plans to suit organizations of all sizes. Upgrade whenever you're ready, with monthly or annual billing options.
Add users as your organization grows and activate or deactivate them as needed, within your subscription limit.
Enjoy professional CAPA software at no cost, with the flexibility to expand when your business needs change.
Free Version

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
Chromebook
Linux

Customer Service / Support

Web-Based Support

Customer Service / Support

24 Hour Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
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

Adaptive Business Management Systems

Date Founded

2009

Company Location

United Kingdom

Company Website

www.adaptivebms.com/CAPA-Software/

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

CAPA

Audit Management
CAPA Planning
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Root Cause Analysis

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
Supplier Quality Control

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