Average Ratings 12 Ratings

Total
ease
features
design
support

Average Ratings 0 Ratings

Total
ease
features
design
support

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Description

Over 1,000 medical device manufacturers rely on Greenlight Guru, a quality management system purpose-built for medtech. The platform is designed around the regulatory environment your industry operates in, not generic enterprise frameworks. FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 11 are aligned at the foundation, not configured later. Implementation takes weeks, not quarters. With 80+ audit-tested templates and medtech-expert support, you avoid the lengthy validation project and launch faster. Greenlight Guru uses AI-powered automation to eliminate manual administrative work while preserving the audit trail and documentation standards your compliance requires. With 15 years in medical device quality systems, Greenlight Guru helps you pass audits, get to market faster, and sustain long-term success.

Description

A well-implemented Quality Management System (QMS) is essential for biotech firms to achieve regulatory compliance. It will also help them maintain product quality and safety. It will also help them manage risks effectively. It will drive operational efficiency. InstantGMP QMS was designed by quality and regulatory professionals for biotech companies. It is simple, affordable, and complete. It can be used by small-to mid-sized manufacturers in many different industries. This quality management software features guided workflows to reinforce adherence with government standards during the entire production process. It also has a variety of innovative features and specialized module. Maintain and improve the safety and quality of biotech products. Frameworks are provided for identifying, assessing and mitigating risk throughout the product's lifecycle to reduce the likelihood of quality incidents or product recalls.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

GitHub Yes 
Google Drive Yes 
Jira Yes 
Microsoft 365 Yes 
Microsoft Edge No 
Microsoft Excel No 
Microsoft Office 2021 No 
Microsoft Word No 
QuickBooks Online No 
Safari No 

Integrations

GitHub No 
Google Drive No 
Jira No 
Microsoft 365 No 
Microsoft Edge Yes 
Microsoft Excel Yes 
Microsoft Office 2021 Yes 
Microsoft Word Yes 
QuickBooks Online Yes 
Safari Yes 

Pricing Details

Modules:
Document Management
Change Management
Training Management
Supplier Management
Design Controls
Risk Management
Parts Management
Quality Events
Software Parts
Software Release Management
SBOM Management
Software Test Automations

Pricing is custom scoped.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac Yes 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Greenlight Guru

Founded

2013

Country

United States

Website

greenlight.guru

Vendor Details

Company Name

InstantGMP

Country

United States

Website

instantgmp.com/products/instant-qms/

Product Features

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking No 
Document Control Yes 
Equipment Management No 
ISO Standards Management Yes 
Maintenance Management No 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

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