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On the recordRead 9 Oct 202624 facts
Agatha SOP
Tokyo, Japan
On the record
- Alerts
- Users receive notifications about SOP updates and upcoming training deadlines.en.agathalife.com · read 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.en.agathalife.com · read 9 Oct 2026
- Compliance
- The maker describes Agatha’s applications as compliant with FDA CFR 21 Part 11, GDPR, and EU Annex 11.en.agathalife.com · read 9 Oct 2026
- Compliance records
- Agatha SOP provides audit records, documented changes, and electronic signatures to document activities for inspection.en.agathalife.com · read 9 Oct 2026
- Controlled print
- The product includes controlled management of paper copies.en.agathalife.com · read 9 Oct 2026
- Electronic signatures
- Agatha SOP provides audit records, documented changes, and electronic signatures to document activity for inspection readiness.en.agathalife.com · read 9 Oct 2026
- Free trial
- The maker offers a free trial but does not state its duration on the pages reviewed.en.agathalife.com · read 9 Oct 2026
- Integrations
- Agatha’s REST API lets applications upload or export items, and the maker describes a customer integration with Sylob ERP.en.agathalife.com · read 9 Oct 2026
- Intended customers
- Agatha presents SOP as part of its life sciences offering for biotech, pharmaceutical, medical device, and contract research organizations.en.agathalife.com · read 9 Oct 2026
- Intended users
- The maker presents Agatha SOP for clinical operations and describes its use by pharmaceutical companies, including for SOP management.en.agathalife.com · read 9 Oct 2026
- Notifications
- Users receive alerts about SOP updates and upcoming training deadlines.en.agathalife.com · read 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.en.agathalife.com · read 9 Oct 2026
- Purpose
- Agatha SOP is a cloud application for creating, reviewing, and approving SOPs and tracking employee training records.en.agathalife.com · read 9 Oct 2026
- Revision control
- Its versioning and approval system tracks changes and retains previous SOP versions with audit trails.en.agathalife.com · read 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.en.agathalife.com · read 9 Oct 2026
- Security certification
- Agatha Inc. lists ISO 27001 certification to ISO/IEC 27001:2022 and JIS Q 27001:2023.en.agathalife.com · read 9 Oct 2026
- Support
- Support is available by email and inquiry form 24/7, with support in English, French, and Japanese.en.agathalife.com · read 9 Oct 2026
- Templates and workflows
- It includes clinical SOP templates and configurable review and approval processes.en.agathalife.com · read 9 Oct 2026