SimplerQMS

SimplerQMS

3.0 out of 5 stars
BatchLine SimplerQMS

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BatchLine:

About

Purpose-built for Pharma and other GxP-regulated companies to digitize production, quality, and compliance for manufacturing operations. Let the data do the talking. Teams take actions from real-time event monitoring into performance, track and solve quality issues as they happen. Give operators a tool that's easy to use and helps them get it right first time. Manufacturing is a complex business, add in GMP regulations and it gets significantly more so. Providing your teams the right tools is an opportunity to solve significant problems and realise transformational improvement. Vastly reduce time and effort for batch review and approval through review-by-exception, no more reviewing entire batch records. Automate wasteful activities like manually inputting and verifying data, moving paper records around the shop floor, performing and checking calculations, workflow management and more.
SimplerQMS:

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.
BatchLine:

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
SimplerQMS:

Platforms Supported

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

Audience

Companies interested in a smart, efficient, digital GxP manufacturing platform
SimplerQMS:

Audience

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

Support

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

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported
BatchLine:

API

Offers API Not Supported
SimplerQMS:

API

Offers API Supported
BatchLine:

Screenshots and Videos

SimplerQMS:

Screenshots and Videos

BatchLine:

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported
SimplerQMS:

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
BatchLine:

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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SimplerQMS:

Reviews/Ratings

Overall 3.0 / 5
ease 3.0 / 5
features 2.5 / 5
design 2.5 / 5
support 3.5 / 5
SimplerQMS:

Pros & Cons from Real Users

Pros

  • The SimplerQMS team have made the transition from a paper based system stress-free and have provided excellent support for my team.
  • 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

  • Some of the existing work flows don't work with our particular processes and we have had to find work arounds.
  • 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.
BatchLine:

Training

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

Training

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

Company Information

BatchLine
Founded: 2015
Thailand
batchline.com
SimplerQMS:

Company Information

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com
BatchLine:

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BatchLine:

Categories

SimplerQMS:

Categories

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

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

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

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
BatchLine:

Integrations

Microsoft 365 Not Supported
Microsoft Entra ID Not Supported
SimplerQMS:

Integrations

Microsoft 365 Supported
Microsoft Entra ID Supported
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