Somru BioScience Inc.Biotech AI Support Assistant
A private AI assistant that answers from a lab's own SOPs and checks validation plans against ICH M10 and internal SOPs.
Check this validation plan against ICH M10 and our SOPs.
Every requirement in the plan is extracted and checked line by line, with SOPs taking priority.
Gap analysisWhich document says that?
Each answer names the SOP or guideline it came from.
From the named documentGap report
- References
- ICH M10 · internal SOPs
- Per gap
- Risk level and mitigation
- Client
- Somru BioScience Inc.
- Location
- Charlottetown, Prince Edward Island, Canada
- Industry
- Life sciences, bioanalytical contract research
- Engagement
- Custom build
- Timeline
- April to May 2025
- Status
- Delivered in 2025
About the client
Somru BioScience Inc.
Charlottetown, Prince Edward Island, Canada
Somru BioScience Inc. is a Canadian biotechnology company and CRO in Charlottetown, Prince Edward Island, offering bioanalytical testing and ELISA kits. We have been Somru's engineering partner since 2020.
Visit somrubioscience.comThe challenge
Regulated labs cannot paste SOPs into a public chatbot. Somru needed answers only from its own documents.
And every new validation plan had to be checked by hand against ICH M10 and Somru's SOPs, which take priority.
What we built
A separate backend service that plugs into Aegyris sign-in.
- 01
Knowledge base and study spaces
With versioned guidelines, SOPs, and study files.
- 02
Validation plan extractor
That lists every parameter and acceptance criterion with its section reference.
- 03
Gap analysis agent
That compares the plan with ICH M10 and the SOP, returning only gaps.
- 04
Usage billing
Recording tokens and cost for every message across three model providers.
Key features
Answers from your documents only
Questions about a named document are answered from that file.
Results
5 weeks
From first commit to deployment on the Aegyris test server
Version history
32
API and WebSocket endpoints
Source
3
Model providers behind one registry: OpenAI, Google Gemini, Anthropic
Source
2 references
Validation plans checked against ICH M10 and internal SOPs
Agent instructions
Per message
Tokens and cost recorded against a pricing history
Source
How it works
Our role
Backend architecture, LLM agent and prompt design, document processing, authentication, usage billing, CI/CD, and test deployment.
Built with
- PyPython
- FaFastAPI
- PoPostgreSQL
- SQSQLModel
- AlAlembic
- ReRedis
- WeWebSockets
- OpOpenAI
- GoGoogle Gemini
- AnAnthropic Claude
- PyPyMuPDF
- FiFirebase Authentication
- DoDocker
- BiBitbucket Pipelines
Work with us
Want an assistant that knows your SOPs?
See the knowledge-base assistant and the validation plan gap analysis, and what your lab's documents would need.