Agatha SOP
Agatha SOP is a cloud application for creating, reviewing, and approving standard operating procedures, while connecting employee training records to the pro…
What Agatha SOP is
Agatha SOP is a cloud application for creating, reviewing, and approving standard operating procedures, while connecting employee training records to the procedures they cover. A structured content editor, clinical SOP templates, and configurable review and approval workflows support document creation and sign-off. Version controls retain earlier SOPs and audit trails record changes. Teams can track training through documents, presentations, videos, and quizzes, with alerts for SOP updates and approaching training deadlines. Audit records and electronic signatures document activity for inspection readiness, and the product also manages controlled paper copies. Its REST API supports uploading and exporting items; Agatha describes a customer connection to Sylob ERP. The company lists ISO 27001 and ISO 9001 certifications and describes its applications as supporting FDA CFR 21 Part 11, GDPR, and EU Annex 11 requirements. Agatha SOP is offered for life sciences organizations, including pharmaceutical, biotech, medical device, and contract research organizations. It is available through web and API access. Pricing is on request, and a free trial is offered, with no duration specified on the SOP datasheet page. Support is available by email and inquiry form 24/7 in English, French, and Japanese.
Good
- Clinical SOP templates and configurable approvals
- Retains prior SOP versions and audit trails
- Links training records to corresponding SOPs
- Alerts users to updates and training deadlines
- Free trial available
Watch out
- Pricing requires contacting Agatha
- Support is limited to email and inquiry form
Who it suits
Agatha SOP suits life sciences teams that need controlled SOP review, revision records, and training linked to procedures. It is presented for clinical operations and organizations such as pharmaceutical, biotech, medical device, and contract research companies.
Verdict
Agatha SOP brings procedure control, employee training records, and inspection-oriented documentation into one cloud application. Prospective users need to request pricing, and the listed free trial has no stated duration.
The facts
Each one read from Agatha SOP's own pages, with the date it was checked.
What it does
- Alerts
- Users receive notifications about SOP updates and upcoming training deadlines.checked 9 Oct 2026
- 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.checked 9 Oct 2026
- Compliance
- The maker describes Agatha’s applications as compliant with FDA CFR 21 Part 11, GDPR, and EU Annex 11.checked 9 Oct 2026
- Compliance records
- Agatha SOP provides audit records, documented changes, and electronic signatures to document activities for inspection.checked 9 Oct 2026
- Controlled print
- The product includes controlled management of paper copies.checked 9 Oct 2026
- Electronic signatures
- Agatha SOP provides audit records, documented changes, and electronic signatures to document activity for inspection readiness.checked 9 Oct 2026
- Integrations
- Agatha’s REST API lets applications upload or export items, and the maker describes a customer integration with Sylob ERP.checked 9 Oct 2026
- Intended customers
- Agatha presents SOP as part of its life sciences offering for biotech, pharmaceutical, medical device, and contract research organizations.checked 9 Oct 2026
- Intended users
- The maker presents Agatha SOP for clinical operations and describes its use by pharmaceutical companies, including for SOP management.checked 9 Oct 2026
- Notifications
- Users receive alerts about SOP updates and upcoming training deadlines.checked 9 Oct 2026
- Pricing
- The product page directs prospective customers to contact Agatha for product inquiries or a demo; it does not state a price.checked 9 Oct 2026
- Purpose
- Agatha SOP is a cloud application for creating, reviewing, and approving SOPs and tracking employee training records.checked 9 Oct 2026
- Revision control
- Its versioning and approval system tracks changes and retains previous SOP versions with audit trails.checked 9 Oct 2026
- 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.checked 9 Oct 2026
- Security certification
- Agatha Inc. lists ISO 27001 certification to ISO/IEC 27001:2022 and JIS Q 27001:2023.checked 9 Oct 2026
- Support
- Support is available by email and inquiry form 24/7, with support in English, French, and Japanese.checked 9 Oct 2026
- Templates and workflows
- It includes clinical SOP templates and configurable review and approval processes.checked 9 Oct 2026
- Training
- The product tracks employee training with documents, presentations, videos, and quizzes, and links training records to their SOPs.checked 9 Oct 2026
- Training records
- The application links employee training records to corresponding SOPs and can track training using documents, presentations, videos, and quizzes.checked 9 Oct 2026
- Version control
- Its workflows retain previous SOP versions and audit trails that capture changes.checked 9 Oct 2026
The company
- Founded
- 2015checked 28 Sep 2026
- Headquarters
- Tokyo, Japanchecked 28 Sep 2026
Money
- Free trial
- The maker offers a free trial but does not state its duration on the pages reviewed.checked 9 Oct 2026
- Trial
- The maker offers a free trial but does not specify its duration on the SOP datasheet page.checked 9 Oct 2026
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