Document work your quality team can follow, step by step.
We build document pipelines and process automation for pharmaceutical and biotech teams. A language model may draft or extract; a plain rule checks every field; a qualified person approves anything that matters. You get the specification, the test evidence and the module documentation with the system.
Three problems we can take on
Each problem below names the rule your inspectors read and what we build against it. We support your validation; your quality unit decides what it requires.
Finding the right answer in controlled documents
Search and answers over SOPs, specifications and work instructions. Each answer links to the passage it came from, and the system says “not in the documents” rather than guessing.
Relevant: EU GMP Chapter 4 (Documentation) and Annex 11 (Computerised Systems).
Turning free text into structured records
Deviation descriptions, complaints or supplier documents drafted into fields by a model, checked field by field by a rule, and approved by a person before anything is saved. A missing value stops the record and names the field.
Relevant: the draft EU GMP Annex 22 on AI, which keeps generative models out of critical GMP applications and asks for human review elsewhere.
Moving data between systems with a record of every step
Robotic process automation for the copying and checking between systems, designed on paper first, with every run, input and change logged and every module documented.
Relevant: audit trails under 21 CFR Part 11, §11.10(e) and the data-integrity expectations in PIC/S PI 041-1.
How we work in a validated environment
We work inside your quality system, not around it. What that means in practice:
- Requirements and design first. You approve the specification before we build. Every later test traces back to it.
- The model never decides. Where a language model is used, its output is a proposal. A deterministic check and a named person decide. We keep models out of decisions with direct impact on patient safety, product quality or data integrity.
- Failure is designed, not discovered. We write down what each step does when an input is missing, malformed or ambiguous, and we test those cases.
- Evidence you can file. Test results, design decisions with the alternatives we rejected, and documentation for each module are handed over with the system.
- Your systems, your data. We build inside your environment and accounts, so your data stays where you keep it during the project. We do not host client data on our own infrastructure. How we handle data and access.
What we can already show
We have no published pharmaceutical project yet. What we can show is the way we build: an AI extractor that is allowed to answer “missing” and stops on any absent field, a file vault where every request passes eight checks in a fixed order, and seven automation processes that have run for a million-customer billing operation since 2018.
Bring one document workflow.
Tell us which documents, which systems and who signs off. An engineer replies within one business day with the questions we would need answered before writing a specification.
Email office@noni-soft.com