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About

K2C PSMF Solution is a modern approach to the management of the Pharmacovigilance System Master File. This document typically requires periodic updates as per significant changes in the pharmacovigilance process. These changes require that multiple company roles are involved in editing a document that is composed of paragraphs and annexes that are all the time same because fixed by regulations. However co-editing is complex; in addition, part of the content should be reserved to some editors and even not available to other contributors. K2C solution allows handling the distinct paragraphs and annexes as single documents, then it offers the possibility to create the PSMF document as a merge of various source documents. K2C PSMF Solution includes management of PSMF contributions (paragraphs and annexes) as distinct documents; management of access rights for viewing or editing of PSMF contributions; and management of the entire lifecycle.

About

SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, 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, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Healthcare companies wanting a tool to streamline their collaboration and regulatory adherence

Audience

Companies in the Life Science industries - Medical Device, Pharmaceutical, Biotechnology, Laboratory, and others.

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

€8,500 one-time payment
Free Version
Free Trial

Pricing

$13,750/year
Free Version
Free Trial

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
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

K2C
United Kingdom
www.k2c.com/products/K2Pharma/PSMF.html

Company Information

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com

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QualityPro by TecWork

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
QT9 QMS

QT9 QMS

QT9 Software

Categories

Categories

Audit Features

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

CAPA Features

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

Compliance Features

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control Features

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

Quality Management Features

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

Integrations

Microsoft 365
Microsoft Entra ID
Microsoft SharePoint

Integrations

Microsoft 365
Microsoft Entra ID
Microsoft SharePoint
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