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What is Stendard Solution?

We are a consultancy and technology firm focused on helping businesses implement international standards, streamline their internal operations, and accelerate their growth in the global marketplace. Our team of ISO consultants is highly skilled and ready to deliver expert advice specifically designed to address your management system requirements. With a wealth of international experience and expertise spanning both hardware and software industries, we have successfully partnered with a wide variety of clients. Whether your goal is to create a comprehensive Quality Management System (QMS) complete with thorough documentation or to maintain its effectiveness via efficient document management and automated workflows, we offer tailored solutions that cater to the distinctive needs of both startups and established companies. Moreover, our dedication to continuous improvement ensures that we remain abreast of the latest industry trends, ultimately enhancing your operational efficiency and effectiveness. By choosing us, you are not only investing in compliance but also in sustainable growth and innovation for your organization.

What is SimplerQMS?

SimplerQMS is a specialized electronic Quality Management System (eQMS) tailored specifically for organizations in the Life Sciences sector. Designed by industry experts, our eQMS ensures compliance with essential regulations such as FDA, ISO, and GxP by facilitating automated and audit-ready quality processes. The platform effectively centralizes and automates fundamental quality workflows within a fully validated, cloud-based system, allowing clients to minimize manual tasks, decrease errors, and maintain consistently organized records that are always inspection-ready. In contrast to standard QMS tools, SimplerQMS is pre-configured to meet the unique requirements of the Life Sciences industry, incorporating templates, workflows, and controls that align with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other relevant standards. Furthermore, clients benefit from a reliable partnership that provides extensive regulatory and quality knowledge, which includes access to audit-proven insights, advice from compliance experts, ongoing system validation, user training, round-the-clock global support, seamless implementation and data migration, along with dedicated Customer Success Experts. Our mission is to empower Life Science companies in efficiently managing quality and regulatory documentation, enabling organizations to thrive from initial growth stages to global operations while enhancing compliance, operational control, and fostering a robust quality culture. By leveraging our expertise, businesses can streamline their processes and ensure they meet the highest industry standards.

Media

Media

Integrations Supported

Integrations Supported

Microsoft 365
Microsoft Entra ID

API Availability

API Availability

Has API

Pricing Information

$250 per month
Free Trial Offered?

Pricing Information

$17,500 / year
We offer subscription-based pricing with everything you need – integrated QMS modules, full implementation and onboarding, validation, user training, cloud hosting, QMS templates, data migration, and ongoing support. No hidden costs.
Free Trial Offered?

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
Online Training

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Stendard

Date Founded

2016

Company Location

Singapore

Company Website

stendard.com

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Categories and Features

Document Control

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

Document Generation

Collaboration
Interaction Tracking
Templates

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Indexing
Document Retention
Electronic Signature
File Recovery
Forms Management
Full Text Search
Optical Character Recognition
Version Control

ISO Compliance

Not specified

Product Compliance

Not specified

Categories and Features

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Forms Management
Issue Management
Mobile Access
Risk Assessment
Workflow Management

CAPA

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

Compliance

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

Document Control

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

ISO Compliance

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

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