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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 MasterControl?

Bringing innovative products to market in heavily regulated sectors often feels like an unending series of compromises. However, MasterControl's GxP software streamlines workflows, ensuring that you don't have to sacrifice quality for cost or innovation in the face of regulation. With a perfect blend of completeness and connectivity, combined with a focus on flexibility and speed, MasterControl Quality Excellence turns quality data and processes into a significant competitive advantage. The journey toward modernizing your manufacturing operations begins with advanced software solutions. MasterControl Manufacturing Excellence simplifies the digital transformation of manufacturing, covering everything from work orders and production records to logbooks and work instructions, making it the most straightforward approach to digitizing your manufacturing processes.

Media

Media

Integrations Supported

Integrations Supported

Inspired eLearning HR & Compliance
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Res_Q
SAP Business ByDesign
Showpad Coach
VIPRE Security Awareness

API Availability

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

$25,000 / 1st year
25k for first year with a 5 license minimum

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub

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

MasterControl

Date Founded

1994

Company Location

United States

Company Website

www.mastercontrol.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

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Training Management

Change Management

Approval Workflow
Audit Trail
Change Planning
Compliance Management
Release Management
Task Management
Training Management

Complaint Management

Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Risk Management
Version Control
Workflow / Process Automation

Document Collection

Not specified

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 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

EHS Management

Not specified

Food Safety

Not specified

IT Risk Management

Not specified

Occupational Health

Not specified

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
Internal Controls Management
Mobile Access
Operational Risk Management
Predictive Analytics
Response Management
Risk Assessment

Safety Management

Not specified

Shop Floor Management

Not specified

SPC

Corrective Actions (CAPA)
Regulatory Compliance

Work Instructions

Version Control

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