MEDTECH
60%
Reduced SOP drafting and update effort
The challenge
Creating and maintaining Standard Operating Procedures (SOPs) is essential for quality, compliance, and operational consistency in life sciences organizations. Yet SOP development remains highly manual, time-consuming, and difficult to scale — especially during new product introductions, process changes, or regulatory updates.
Asteri enables organizations to deploy an AI agent that supports SOP creation and updates — accelerating documentation while preserving human review, approval, and accountability.
The Solution
From: 100% Human-Led SOP Development
In traditional SOP authoring, quality and operations teams manage the entire process manually:
Gather inputs from subject matter experts across functions
Review existing SOPs, templates, and reference documents
Manually draft procedures, step-by-step instructions, and control points
Ensure alignment with internal quality standards and regulatory expectations
Coordinate reviews, revisions, and approvals across stakeholders
Update SOPs during product launches, process changes, or audits
Maintain version control and documentation history manually
To: AI-Powered SOP Creation with Humans in the Loop
With Asteri, an AI agent accelerates SOP creation and updates by handling the operational drafting work, while humans retain full control over review and approval.
Tasks handled by the Asteri AI agent:
Ingest relevant inputs, including existing SOPs, templates, process documentation, and regulatory guidance
Generate structured SOP drafts aligned to organizational standards and formats
Draft step-by-step procedures for quality processes, manufacturing operations, or new product introductions
Incorporate required control points, roles, and responsibilities
Highlight gaps, inconsistencies, or outdated sections during revisions
Maintain version history and traceability of source inputs
Prepare SOP drafts and change summaries for human review
Tasks retained by human teams:
Review, edit, and validate SOP content
Confirm regulatory and quality compliance
Approve final SOPs and manage formal release
Train teams and ensure operational adoption
Respond to audit findings and inspection feedback
The Impact
Reduce SOP drafting and update effort by up to 60%
Shorten SOP creation cycles from weeks to days
Improve consistency across procedures and product lines
Free quality and operations teams to focus on risk, oversight, and improvement
Support faster, more compliant new product introductions
Join our mission
Help us make a dent in the universe by contributing to our mission
of reimagining the future of human–AI workforces.
Request demo
Copyright 2025 © Asteri AI, Inc.
Email: info@asteri.ai