document. track training. ensure compliance.
A cloud-based application for creating and managing standard operating procedures and employee training documents to ensure accurate records and complete compliance.
Manage SOPs and Employee Records
Standard policies are at the heart of every quality operation, supporting regulatory requirements, and ensuring effective operations. The creation and management of SOPs is a critical process for every life sciences company.
Agatha SOP is designed for organizations that need to implement a solution immediately while being able to scale quickly to address rapid growth.
Unlike other solutions, Agatha SOP is available as a cloud-based application, ready to use immediately with standard templates and processes. That means there are no delays with an extensive planning and configuration project – you can start managing SOPs the same day you adopt Agatha and then adjust the application to your needs as you go.
Start using a complete SOP solution that is pre-configured, validated, and ready to put into production immediately.
Easy Audit Preparation
Simplify audit preparation with complete SOP documents, accurate training records, and specialized views and reports for inspectors.
Provide training documents and videos, apply quizzes and collect training documents to ensure effective training.
Coordinate and track end-to-end SOP creation, review, approval, and training processes with automated workflows and change controls.
Trigger periodic reviews automatically at pre-set intervals to ensure up-to-date training activities and comprehensive documentation.
Audit records, documented changes, and electronic signatures ensure every activity is fully documented and ready for inspection.
SOPs are one of the basic building blocks that lead to better data integrity and successful clinical trials. <They> can result in reductions in churn, noncompliance, and questionable data. Consistent implementation of procedures allows clinical staff to better focus on study activities and keep patients safe.
Agatha SOP Features
Create and document comprehensive
policies from your own tailored
legal & regulatory
Address the legal and regulatory
rules that apply to your company for
Versions & Audits
Maintain prior versions of all SOPs and
audit trails, documenting all changes to
Track employee SOP compliance and
training activities. Require successful completion of quizzes to ensure new processes are understood.
Review & Approval
Manage and monitor processes for
creation, review, and approval of SOPs
with ready-to-use, easy-to-modify
Ensure that paper based copies are managed properly with Controlled Print.
Inspection-ready Management of Essential TMF Documents and Records
Creation, Review and Approval of SOPs and Employee Training Records
Quality Document and Process Management for CAPAs, Deviations, & Change Control
Easily manage your regulatory documentation following the EDM Reference Model.
But not just any trial - an Agatha trial.
Agatha offers a fully supported free pilot where you can test our applications using your real information and processes.
Just fill in the form
and we’ll get right back to you to get you set up.
If you're not sure, you can learn more about our Pilot process here. If you’re not quite ready to sign up for the pilot, request a demo instead.