RegDocs365

RegDocs365

Court Square Group
+
+

Related Products

  • Interfacing Integrated Management System (IMS)
    66 Ratings
    Visit Website
  • isoTracker Quality Management
    19 Ratings
    Visit Website
  • LogicalDOC
    150 Ratings
    Visit Website
  • SBS Quality Management Software
    7 Ratings
    Visit Website
  • UnForm
    19 Ratings
    Visit Website
  • Intelex
    193 Ratings
    Visit Website
  • Dynamo Software
    71 Ratings
    Visit Website
  • Process Street
    1,119 Ratings
    Visit Website
  • Adobe Acrobat
    8,459 Ratings
    Visit Website
  • Qualio
    919 Ratings
    Visit Website

About

Out-of-the-box, scalable, real-time collaborative solution for CRO’s, Life Science Consultants, Regulatory Groups and Industry Stakeholders. Built in an Audit Ready Compliant Cloud (ARCC) environment. Meets all 21 CFR Part 11 requirements. GxP audit ready. Pre-configured Departmental. Internal/External stakeholder communications. Secure data integration across remote teams. Collaborative review and approval workflow. Turn access on/off as needed (EX: auditors, reducing audit prep time to hours vs days). Preconfigured to EDM & eTMF Reference Models. Improve workflows through intelligent content management tools. Unify and improve the document management lifecycle with real-time collaboration, automatic indexing, and co-authoring capabilities. Pre-configured validated system that easily manages documents and data electronically that complies with eCTD mandates.

About

SimplerQMS is an electronic quality management system (eQMS) built by life science experts. It helps life science companies stay compliant with FDA, ISO, and GxP requirements while reducing manual work and improving audit readiness. With SimplerQMS, teams can easily manage documents, change control, training, CAPA, analytics, and more on one cloud-based platform. The system is fully validated, so companies can start quickly without a long validation process. What customers appreciate most: • Compliant processes and fewer manual errors • Fast implementation and smooth data migration • User training and 24/7 global support • Guidance from compliance experts throughout the journey Whether you're a growing startup or an established life science company, SimplerQMS gives you the tools and support to build a strong quality culture and stay audit-ready every day.

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

Audience

Pharmaceutical, biotech, life science, medical device vendors, and more

Audience

Startups and Growing Life Science Companies – Medical Devices, Pharmaceutical, Biotech, Laboratories, CRO / CMO

Support

Phone Support Supported
24/7 Live Support 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

Per user, Per month
Free Version Not Supported
Free Trial Not Supported

Pricing

$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 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:

Review this Software

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 Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Training

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

Company Information

Court Square Group
Founded: 1995
United States
www.regdocs365.com

Company Information

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com

Alternatives

Alternatives

isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd
Cloudbyz eTMF

Cloudbyz eTMF

Cloudbyz
QEdge

QEdge

Sarjen Systems Pvt Ltd
LifeSphere eTMF

LifeSphere eTMF

ArisGlobal
QualityPro by TecWork

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.
cubeCTMS

cubeCTMS

CRScube
QT9 QMS

QT9 QMS

QT9 Software
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences

Categories

Categories

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

Clinical Trial Management Features

21 CFR Part 11 Compliance Supported
Document Management Supported
Electronic Data Capture Supported
Enrollment Management Not Supported
HIPAA Compliant Supported
Monitoring Not Supported
Patient Database Not Supported
Recruiting Management Not Supported
Scheduling Not Supported
Study Planning Not 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

Crow Canyon Contract Management Supported
Microsoft 365 Not Supported
Microsoft Entra ID Not Supported

Integrations

Crow Canyon Contract Management Not Supported
Microsoft 365 Supported
Microsoft Entra ID Supported
Claim RegDocs365 and update features and information
Claim RegDocs365 and update features and information
Claim SimplerQMS and update features and information
Claim SimplerQMS and update features and information