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What we build
Platforms and services for regulated life sciences.
Each offering is designed to sit inside the organization’s quality system — inspectable by Computer System Validation, operable by IT, usable by science.
Nothing here is a certification, and nothing here replaces the regulated company’s decision to accept a system.
01
Data platforms & analytics workspaces
Clinical, quality, and R&D groups rarely lack data. They lack a place to use it without losing the story of where it came from. AmiSoft data platforms give organizations governed zones, attributable access, and analysis workspaces that sit on those zones instead of copying everything into a shared folder.
This offering fits when the need is self-service analysis, a clinical data review space, or a quality data mart that must not become a shadow database.
02
Scientific computing environments
Scientific work needs runtimes: packages, jobs, notebooks, and pipelines. In a GxP setting those runtimes have to be definable. AmiSoft computing environments are controlled places to run that work — with package provenance, retained run context, and a clear line between exploration and a formal path.
This is the offering when scientists are still on unmanaged laptops, and quality is asking what, exactly, will be validated.
03
Software & integration services
Most programs stall in the space between systems, not inside a single tool. AmiSoft integration services cover exchange among laboratory, clinical, quality, and enterprise platforms, scoped so a project plan has a delivery team.
We work from patterns for file- and API-based exchange. We do not promise that every instrument already has a connector. Where a system should stay the source of record, we say so.
04
Compliance & qualification support
A platform that cannot be explained to a quality unit will not go live. AmiSoft provides traceability, test-evidence patterns, and change-control language that teams can adapt to the organization’s own procedures.
Buyers will still ask about 21 CFR Part 11 and EU Annex 11. The careful answer is specific: which records are electronic records, who can change them, and how that change is attributed. We help prepare that answer.
We do not issue a Part 11 certificate, and we do not call the platform validated, certified, or approved.
Not sure which offering fits?
Two or three specifics on the contact page will help draw the boundary before it is written into a plan.