Artificial intelligence, cloud systems, automation and digital quality platforms are increasingly used in quality, manufacturing, laboratory, documentation and data management processes.
For regulated companies, it is not enough to test new technologies. Their use must be controlled, documented, auditable and aligned with GxP, GMP, CSV, CSA and data integrity principles.
Qvalitek helps companies prepare for controlled AI and digital quality system use: we assess risks, prepare governance documents, SOPs, vendor assessment questionnaires, training programs and validation strategy.
Who is this for?
These services are intended for companies that:
- are considering the use of ChatGPT, Copilot, Gemini, DeepL or other AI tools in business processes;
- plan to implement eQMS, LIMS, MES, ERP, DMS or other systems with AI features;
- want to assess where AI use may impact GxP processes;
- see informal AI use by employees and want to control it;
- want to prepare AI use policies, SOPs and risk assessment templates;
- are preparing for audits, customer questionnaires or regulatory changes;
- want to move from traditional CSV to risk-based CSA.
Services
AI use-case and GxP risk assessment
We help identify where AI is already used or could be used within the organization and assess whether specific use cases may impact product quality, patient safety, data integrity or GxP processes.
The service may include:
- AI use-case inventory;
- GxP / non-GxP classification;
- data sensitivity assessment;
- AI risk matrix;
- list of allowed, restricted and prohibited AI use cases;
- prioritized AI readiness action plan.
AI governance and SOP pack
We prepare practical documents that help employees understand when AI tools may be used, what data must not be entered, when human review is required and how AI risk should be controlled.
The service may include:
- AI use policy;
- AI governance SOP;
- AI risk assessment template;
- AI output review SOP;
- AI vendor questionnaire;
- AI incident and error handling procedure;
- AI change control template;
- employee training material.
AI vendor and tool qualification
Many companies will not build their own AI solutions but will purchase systems where AI features are already embedded. Qvalitek helps assess whether such tools are suitable for use in regulated environments and what controls are required before use.
We assess:
- vendor documentation;
- data security and confidentiality aspects;
- audit trail, access control and logging capabilities;
- model or feature change management;
- GxP impact;
- data integrity risks;
- additional documentation and testing needs.
CSV / CSA modernization
We help companies move from traditional computer system validation toward a risk-based Computer Software Assurance approach, especially when cloud, automation or AI-enabled systems are planned.
The service may include:
- review of current CSV methodology;
- CSV / CSA gap assessment;
- risk-based testing model;
- supplier documentation leverage;
- URS, risk assessment, test plan and validation summary templates;
- AI-ready computerized systems guidance.
AI in GxP training
We provide practical training for QA, QC, IT, validation, manufacturing, laboratory and management teams on AI opportunities, risks and controls in regulated environments.
Training topics:
- AI use in GxP environments;
- risks of ChatGPT, Copilot and other AI tools;
- data confidentiality and data integrity;
- AI use-case risk assessment;
- AI governance and SOPs;
- AI-ready CSV / CSA;
- human review and accountability when using AI.
How we work
1. Situation analysis
We assess the systems, processes, data and AI use cases relevant to your organization.
2. Risk classification
We separate low, medium and high-risk use cases and assess GxP impact and data sensitivity.
3. Control selection
We prepare recommendations for SOPs, training, vendor assessment, change control, output review and validation strategy.
4. Documentation and training
We prepare practical documents, templates and training materials that can be integrated into the company quality system.
5. Pilot readiness
We help select safe, controlled and auditable AI use cases for future pilots.