RegDoc eSafe

RegDoc eSafe

MedPoint Digital
+
+

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About

An eReg platform built with the study site in mind. Fast implementation, no forced workflow, intuitive design and function. Try RegDoc eSafe free today! A secure lock-box for source documents, with tools that make it easy to transfer, redact and assign role-based, time-limited remote access to these sensitive documents. RegDoc eSafe is designed for fast, flexible configuration, intuitive use with minimal training, and a thorough but streamlined validation process. Streamlined implementation process to get your clinical study sites up and running quickly. Regulatory binder templates pre-loaded into your site for easy access. User upload and access control configuration. Admin and user training sessions. MedPoint is committed to compliance and walks you through the necessary steps to validate our software. MedPoint is regularly audited by study sponsors and has long experience developing and supporting validated systems.

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 Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported

Audience

Researchers and analytic experts searching for a solution to improve and manage their operations

Audience

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

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

Contact MedPoint Digital for pricing details.
Free Version Not Supported
Free Trial Not Supported

Pricing

$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Version Not Supported
Free Trial Supported

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:

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Reviews/Ratings

Overall 1.0 / 5
ease 1.0 / 5
features 1.0 / 5
design 1.0 / 5
support 2.0 / 5

Pros & Cons from Real Users

Pros

  • The technical staff were the best part of our experience. During onboarding they made a real effort to explain how the system works and to help whenever we had questions, and they were responsive and patient throughout. The platform is built on Microsoft Azure and Microsoft 365, so documents live in a familiar SharePoint/Office environment rather than in a completely proprietary system.

Cons

  • In our experience the system is extremely inconvenient, cumbersome and inflexible. Everyday document work requires far more clicks and steps than it should, the interface is heavy, and adapting the workflows to how our company actually operates proved impractical. After evaluating it we decided not to implement it at all. The far bigger problem is the commercial side. Read the termination and renewal provisions extremely carefully before signing. Based on our experience you cannot simply stop using the service during the contract year and stop paying. Notice must be given at least 90 days before the renewal date; miss that deadline and you may be invoiced for another full contractual period even though you no longer use the system. Termination must be submitted in writing and its receipt expressly confirmed. We told the company twice by telephone that we wanted to discontinue the service, and those conversations were not treated as formal notice. Do not rely on phone calls: send written notice, request written confirmation, and keep all correspondence.

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Company Information

MedPoint Digital
United States
www.medpt.com/site-services/

Company Information

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com

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Categories

Categories

Audit Supported
CAPA Supported
Compliance Supported
Document Control Supported
ISO Compliance Supported
Quality Management Supported

Document Control Features

Archiving & Retention Not Supported
Automated Routing Not Supported
Change Management Not Supported
Compliance Management Not Supported
Electronic Signature Not Supported
Escalation Management Not Supported
Periodic Review Not Supported
Version Control Not Supported

Document Management Features

Access Controls Not Supported
Archiving & Retention Not Supported
Collaboration Tools Not Supported
Compliance Tracking Supported
Document Archiving Supported
Document Assembly Not Supported
Document Capture Not Supported
Document Conversion Not Supported
Document Delivery Not Supported
Document Indexing Not Supported
Document Retention Not Supported
Electronic Signature Not Supported
Email Management Not Supported
File Recovery Not Supported
File Type Conversion Not Supported
Forms Management Not Supported
Full Text Search Not Supported
Offline Access Not Supported
Optical Character Recognition Not Supported
Print Management Not Supported
Version Control Supported

Document Control Features

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

Audit Features

Alerts / Notifications Supported
Audit Planning Supported
Compliance Management Supported
Dashboard Supported
Exceptions Management Not Supported
Forms Management Supported
Issue Management Supported
Mobile Access Supported
Multi-Year Planning Not Supported
Risk Assessment Supported
Workflow Management Supported

CAPA Features

Audit Management Supported
CAPA Planning Supported
Change Management Supported
Complaint Management Supported
Incident Management Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Root Cause Analysis Not Supported
Training Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Not Supported
Controls Testing Not Supported
Environmental Compliance Not Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Not Supported
ISO Compliance Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Integrations

Microsoft 365 Not Supported
Microsoft Entra ID Not Supported

Integrations

Microsoft 365 Supported
Microsoft Entra ID Supported
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