LISC is a platform that redefines regulatory compliance in the pharmaceutical and Life Sciences industry. It helps teams move from time-consuming creation and management of static documentation to intelligent, records-based compliance supported by artificial intelligence models. Documentation can become the outcome of a structured compliance process, not the process itself.
Our first product is LISC Risk Assessment: an AI-supported solution that prepares FMEA drafts for validation projects in minutes. It rapidly maps and assesses risk based on input documentation (URS, SOPs and technical documentation).
LISC Risk Assessment is the first product developed as part of LISC: a new approach to Life Sciences compliance built around structured data, risk logic and working with records, not only documents.
The tool supports Validation, QA and CSV teams in preparing risk assessments in FMEA format for validation projects. It helps organise input data, translate it into a consistent risk structure and prepare review-ready material for expert evaluation.
Requirements, process descriptions, URS, expert comments and previous documents are often dispersed across files, teams and tools.
LISC helps consolidate scattered inputs into a structured starting point for risk assessment.
Building the FMEA structure, describing risks and organising dependencies between requirements can take many hours of preparation.
LISC supports the creation of a structured draft that an expert can then assess, correct and develop further.
Risk assessment material often reaches review only after multiple rounds of corrections, additions and manual context-building.
LISC helps prepare a more complete and readable basis for expert verification.
Validation experts should focus on assessing risk and making decisions, not repeatedly rewriting and organising data.
LISC shifts their work from creating a document from scratch to review, correction and approval.
From input data to a structured FMEA draft, with the expert at the centre of the process.
You add requirements, process descriptions, system context and available project materials, such as URS, specifications or previous analyses.
LISC organises the information, identifies risk areas and prepares a structured FMEA draft as a starting point for further work.
The expert verifies the risk logic, adds project context, corrects proposed elements and makes decisions that require domain knowledge.
The team receives consistent material ready for further review, use in documentation and the formal approval process.
Important: LISC does not automatically approve risk assessments and does not replace expert judgment. The tool prepares the risk assessment; its evaluation, decision-making and formal approval remain with a human expert.
Your data is stored in the Azure cloud on EU-based servers, in a separate instance for each client, and is not used to train language models.
We perform regular data backups. You do not need to organise your own backup procedures for data processed in LISC, because this is handled on our side in line with data integrity expectations for GxP environments.
Infrastructure: Azure EU | ISO 27001 | ISO 27017 | SOC 2
In accordance with the EU Artificial Intelligence Act (AI Act, applicable from 2025), LISC is classified as a limited-risk AI system — a tool supporting the preparation of documentation, without autonomous decision-making. It is not subject to the requirements applicable to high-risk systems.
The transparency obligation is met by design: the user is always aware that they are working with AI-generated content and is required to verify it before use.
Current regulations are changing dynamically to ensure the harmonized and safe use of AI models across a wide range of applications. For this reason, we carried out a comprehensive review of existing regulations, including the AI Act, GAMP 5 Vol. 2, the GAMP 5 AI Guide, EudraLex Volume 4 Annex 11 and Annex 15, as well as non-binding proposals such as EudraLex Volume 4 Annex 22. As a result, LISC was assessed as a non-GxP, low-risk tool requiring continuous human oversight (HITL).
LISC is not a standard software tool and it is not an AI model itself. It is a tool that uses AI, based on an LLM, where the core configuration consists of prompts and application code. For this reason, we prepared a Risk Analysis to verify its potential impact on key Life Sciences areas, including product quality, patient safety and data integrity. We also prepared an Intended Use document describing how the tool works, the specification.
LISC is configured commercial software. Based on our intended use and risk assessment, it does not require formal validation on the client side before implementation. An Intended Use document defining the scope of use is available on request for auditors and internal QA teams.
GMP Annex 11 and Annex 15 are not considered directly binding for LISC in this context because the system has been assessed as non-GxP. This position has been justified and documented in the risk assessment performed for the solution.
LISC is designed in line with the model expected for non-critical AI use in a GxP environment: AI prepares the analysis, while a qualified expert evaluates and approves it. No decision is made automatically.
"I help Life Sciences teams find practical ways to improve the way they work with risk assessment and validation documentation."
From system validation to manufacturing process validation.
A living risk register covering the full risk lifecycle.
From URS and risk assessment to ready-to-use test scripts, without manual mapping and with full traceability.
A system change? LISC indicates what needs to be revalidated. Minutes instead of weeks of change impact assessment.
We connect to existing paperless systems where they are already in place. We also work as a standalone solution when they are not.
Creation of User Requirements Specifications (URS) based on documents that contain organisational and process context.
No. LISC supports the preparation of risk assessments and FMEA drafts, but it does not make decisions or replace formal review. The expert verifies the output, adds project context and remains responsible for approval.
LISC Risk Assessment is designed for Validation, QA, CSV, IT Quality and Compliance teams in Life Sciences organizations that prepare risk assessments, FMEA and validation documentation for GxP environments.
LISC helps structure input data such as requirements, URS, process descriptions and technical documentation, then prepares a structured FMEA draft ready for expert review.
LISC is designed with data security, transparent AI use and expert control in mind. Client data remains under the organization’s control, while the tool output requires human review and approval.
