SOP

Agatha SOP is a cloud-based Standard Operating Procedure management software developed by Agatha Corporation, designed for life sciences organisations conducting clinical trials. It enables teams to create, review, approve, and track SOPs alongside employee training records within a single, unified application, ensuring regulatory compliance and inspection readiness at every stage of clinical operations.

By combining SOP management and employee training record tracking in one platform, Agatha SOP simplifies quality control processes, reduces administrative burden, and delivers actionable insights that improve both individual performance and overall business operations. The software comes equipped with standard templates, configurable workflows, electronic signatures, and full audit trail capabilities to meet regulatory requirements.

Key Benefits

• Centralized and Structured SOP Organization: All SOPs are securely stored and managed in the cloud, with an intuitive classification system that ensures quick and structured access to essential documents.
• Automated Revision and Approval Tracking: Built-in versioning and approval workflows keep SOPs up-to-date and compliant with current regulations, with changes tracked in real-time to facilitate seamless implementation of updates.
• Transparent Management of Training Records: Training records are automatically linked to their corresponding SOPs, ensuring every employee has received and understood the guidelines relevant to their role.
• Enhanced Traceability and Compliance: A complete history of approvals, completed training, and document updates is maintained, simplifying audits and regulatory inspections. Training records and certificates support full compliance.
• Automated Notifications and Reminders: Users receive alerts about SOP updates and upcoming training deadlines, reducing the risk of non-compliance and missed requirements.
• Time Savings and Reduced Risk of Errors: Automating SOP management and training record tracking reduces administrative workload and minimises human errors, freeing teams to focus on higher-value tasks.

Main Features and Capabilities

• Clinical SOP Templates: Comprehensive, step-by-step templates allow teams to assemble and execute detailed policies. Systematic reviews are triggered automatically to ensure training activities and documentation remain current and aligned with clinical research trial requirements.
• Creation, Review, and Approval Workflows: Easy-to-modify workflows provide control and monitoring over the full SOP lifecycle. Previous versions of all SOPs are retained, and efficient audit trails capture every change, supporting defence against adverse events.
• Compliance Monitoring: Teams can oversee employee SOP compliance and training activities using a variety of resource formats including documents, presentations, and videos. Mandatory quizzes can be configured to confirm employee understanding of new processes, and regular verification of responsible individuals ensures consistent training standards.
• Controlled Print Management: The platform guarantees proper management of paper copies of SOPs, ensuring compliance with company quality standards for physical document handling.

Agatha SOP is a cloud-based solution that supports electronic signatures, documented change histories, and audit records to ensure full regulatory compliance and inspection readiness. It is suitable for clinical research organisations seeking to standardise operations, streamline quality management, and maintain robust traceability across SOP and training workflows.