+
+

Related Products

  • Lockbox LIMS
    72 Ratings
    Visit Website
  • Interfacing Integrated Management System (IMS)
    66 Ratings
    Visit Website
  • QBench
    153 Ratings
    Visit Website
  • Qualio
    919 Ratings
    Visit Website
  • Process Street
    1,119 Ratings
    Visit Website
  • AlisQI
    108 Ratings
    Visit Website
  • Epsilon3
    265 Ratings
    Visit Website
  • MaintainX
    2,692 Ratings
    Visit Website
  • VKS
    26 Ratings
    Visit Website
  • Acadia
    3 Ratings
    Visit Website

About

Agatha offers a suite of cloud-based applications tailored to the life sciences industry, enabling centralized management of documents and processes across clinical operations, quality, regulatory, and training functions. It supports biotech, pharmaceutical, medical-device, and contract-research-organization workflows by offering modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, SOP creation and approval, Quality document management for CAPAs, deviations, and change controls, and regulatory document management. Agatha enables streamlined document creation, review, approval, storage, and sharing in one unified system, supports paperless transformation to reduce administrative burden and strengthen data security, and is built on a global-compliance architecture addressing standards like 21 CFR Part 11, GDPR, and EU Annex 11.

About

Flinn is an AI-driven platform built to automate and streamline regulatory and quality-management processes within the medical-device (MedTech) industry. It enables manufacturers to integrate AI into repetitive and complex workflows such as post-market surveillance, literature evaluation, complaint-handling, and safety-database monitoring, reducing manual effort and ensuring compliance with standards like the EU Medical Device Regulation (MDR). It aggregates data across sources, applies machine-learning algorithms to detect patterns and risks, generates regulatory-compliant reports automatically, and supports rapid launch and operation of high-quality products at scale. As a result, organizations can achieve up to a tenfold acceleration in process efficiency while maintaining auditability, transparency, and traceability of their compliance workflows.

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 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

Audience

Clinical-operations, regulatory-affairs and quality-assurance teams searching for a tool to support studies, audits and global operations

Audience

MedTech companies’ quality, regulatory and compliance teams seeking a tool to automate and scale regulatory workflows, achieve faster product launch and ensure full compliance with global medical-device regulations

Support

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

Support

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

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

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

Pricing

No information available.
Free Version Not Supported
Free Trial Not 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 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 Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Training

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

Company Information

Agatha
Founded: 2015
United States
en.agathalife.com

Company Information

Flinn
Founded: 2022
Austria
www.flinn.ai/

Alternatives

Alternatives

ViSU

ViSU

DDi
Threat Detective

Threat Detective

Threat Detective Ltd
Lockbox LIMS

Lockbox LIMS

Third Wave Analytics
KOŚA DMS

KOŚA DMS

KOŚA
Kymolog

Kymolog

Saga IT

Categories

Categories

Integrations

No info available.

Integrations

No info available.
Claim Agatha and update features and information
Claim Agatha and update features and information
Claim Flinn and update features and information
Claim Flinn and update features and information