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What is SimplerQMS?

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. This innovative platform ensures adherence to an array of regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others, and is fully validated under GAMP5 guidelines. The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities. Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel. In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

What is KOŚA DMS?

KOŚA DMS is an all-encompassing cloud-based document management system designed for organizations operating in the pharmaceutical, biotechnology, medical device, and wider life sciences industries. It supports the development, review, approval, distribution, and tracking of controlled documents, while also incorporating workflows for standard operating procedures (SOPs), policies, forms, and vital quality records. The solution offers role-based access control, electronic signatures, audit trails, and periodic review features, enabling teams to maintain a clear and compliant document history for regulated activities. Its integration with Microsoft Word simplifies the drafting process, allowing users to create documents in an environment they are already comfortable with, while links to ERP and LIMS systems provide seamless connections to operational workflows. Tailored for teams in quality assurance, quality control, regulatory affairs, and document control, KOŚA DMS effectively coordinates document lifecycle management across multiple locations and functions, fostering adherence to industry regulations. Moreover, the intuitive interface enhances user experience, enabling teams to manage their document processes with ease and efficiency, thereby minimizing potential disruptions. This comprehensive approach not only streamlines operations but also promotes organizational efficiency and compliance.

Media

Media

Integrations Supported

Microsoft 365
Microsoft Entra ID

Integrations Supported

Microsoft Word

API Availability

Has API

API Availability

Has API

Pricing Information

$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Trial Offered?

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS
Android
iPhone
iPad
Windows

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour 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
Webinars
On-Site Training

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Company Facts

Organization Name

KOŚA

Date Founded

2025

Company Location

India

Company Website

kosa-ai.com/pharmaceutical-document-management-system/

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

Categories and Features

Document Control

Not specified

Document Management

Not specified

Document Workflow

Not specified

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