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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

Validfor is a secure, modular digital validation platform that centralizes the entire validation lifecycle on a single, paperless system. Designed specifically for regulated industries, Validfor enables efficient validation while ensuring full compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11. The platform supports electronic records and advanced electronic signatures with full audit trails, role-based workflows (Author, Reviewer, Approver), and complete CSV compliance. All documents and records are securely managed in a centralized repository, capturing every change with full traceability to protect data integrity and Quality Assurance. Validfor offers integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, enabling seamless impact assessments, CAPA tracking, Computer Software Assurance (CSA), and audit-ready lifecycle management.

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 Supported

Audience

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

Audience

Primary: Pharmaceutical & Life Sciences Companies Quality Assurance & Validation Teams Secondary: Regulated Manufacturing Organizations Compliance & CSV Professionals GxP-regulated Enterprises

Support

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

Support

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

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Reviews/Ratings

Overall 5.0 / 5
ease 4.0 / 5
features 5.0 / 5
design 5.0 / 5
support 5.0 / 5

Pros & Cons from Real Users

Pros

  • Strong audit trail mindset and a clean approval workflow. I like that evidence stays attached to the work items it belongs to, which makes audit narratives easier.

Cons

  • I want more guardrails/templates for teams new to VLM so they don't invent inconsistent structures across departments. Also would like more flexible approval routing patterns for complex orgs.

Training

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

Training

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

Company Information

Agatha
Founded: 2015
United States
en.agathalife.com

Company Information

Validfor
Founded: 2024
Estonia
validfor.com

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Categories

Categories

Integrations

No info available.

Integrations

No info available.
Claim Agatha and update features and information
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