Agatha SOP

Spec sheet

Purpose

Agatha SOP is a cloud application for creating, reviewing, and approving SOPs and tracking employee training records.Read 9 Oct 2026 · en.agathalife.com

Intended users

The maker presents Agatha SOP for clinical operations and describes its use by pharmaceutical companies, including for SOP management.Read 9 Oct 2026 · en.agathalife.com

Trial

The maker offers a free trial but does not specify its duration on the SOP datasheet page.Read 9 Oct 2026 · en.agathalife.com

Integrations

Agatha’s REST API lets applications upload or export items, and the maker describes a customer integration with Sylob ERP.Read 9 Oct 2026 · en.agathalife.com

Compliance

The maker describes Agatha’s applications as compliant with FDA CFR 21 Part 11, GDPR, and EU Annex 11.Read 9 Oct 2026 · en.agathalife.com

Support

Support is available by email and inquiry form 24/7, with support in English, French, and Japanese.Read 9 Oct 2026 · en.agathalife.com

Headquarters

Tokyo, JapanRead 28 Sep 2026 · en.agathalife.com

Founded

2015Read 28 Sep 2026 · en.agathalife.com

Alerts

Users receive notifications about SOP updates and upcoming training deadlines.Read 9 Oct 2026 · en.agathalife.com

API and integrations

Agatha describes a REST API that allows external applications to upload or export items; a customer describes using it to connect Agatha with Sylob ERP.Read 9 Oct 2026 · en.agathalife.com

Compliance records

Agatha SOP provides audit records, documented changes, and electronic signatures to document activities for inspection.Read 9 Oct 2026 · en.agathalife.com

Controlled print

The product includes controlled management of paper copies.Read 9 Oct 2026 · en.agathalife.com

Electronic signatures

Agatha SOP provides audit records, documented changes, and electronic signatures to document activity for inspection readiness.Read 9 Oct 2026 · en.agathalife.com

Free trial

The maker offers a free trial but does not state its duration on the pages reviewed.Read 9 Oct 2026 · en.agathalife.com

Intended customers

Agatha presents SOP as part of its life sciences offering for biotech, pharmaceutical, medical device, and contract research organizations.Read 9 Oct 2026 · en.agathalife.com

Notifications

Users receive alerts about SOP updates and upcoming training deadlines.Read 9 Oct 2026 · en.agathalife.com

Pricing

The product page directs prospective customers to contact Agatha for product inquiries or a demo; it does not state a price.Read 9 Oct 2026 · en.agathalife.com

Revision control

Its versioning and approval system tracks changes and retains previous SOP versions with audit trails.Read 9 Oct 2026 · en.agathalife.com

Security and compliance

Agatha Inc. lists ISO 27001 and ISO 9001 certifications, and the maker describes its applications as supporting FDA CFR 21 Part 11, GDPR, and EU Annex 11 requirements.Read 9 Oct 2026 · en.agathalife.com

Security certification

Agatha Inc. lists ISO 27001 certification to ISO/IEC 27001:2022 and JIS Q 27001:2023.Read 9 Oct 2026 · en.agathalife.com

Templates and workflows

It includes clinical SOP templates and configurable review and approval processes.Read 9 Oct 2026 · en.agathalife.com

Training

The product tracks employee training with documents, presentations, videos, and quizzes, and links training records to their SOPs.Read 9 Oct 2026 · en.agathalife.com

Training records

The application links employee training records to corresponding SOPs and can track training using documents, presentations, videos, and quizzes.Read 9 Oct 2026 · en.agathalife.com

Version control

Its workflows retain previous SOP versions and audit trails that capture changes.Read 9 Oct 2026 · en.agathalife.com

Where Specifiction places it

• SOP Software#8 of 308.2