QMS and AI quality services for life sciences
QLogix works in five practice areas, delivered separately or as one program. Each starts from the quality system you already have and keeps every GxP decision with qualified people.
- 01
QMS digitization
QMS digitization is the move from paper or hybrid quality processes to a validated electronic quality management system. QLogix selects the platform that fits your size and product type, configures it to your SOPs, validates it and migrates the records you need to keep.
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AI-assisted investigations
An AI-assisted investigation uses AI to prepare the groundwork of a deviation investigation: the problem statement, similar past events, root cause candidates and a draft CAPA plan. The investigator and QA review, edit and approve every part. The AI drafts; it does not conclude.
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Connected quality data
Connected quality data means linking the QMS to the plant and lab systems around it (MES, LIMS, ERP and electronic batch records) so that quality events, batch data and lab results can be trended together. It turns a QMS that records everything into one that also shows patterns before they become recurrences.
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Validation of AI-enabled systems
Validating an AI-enabled system means showing, with documented evidence, that each AI function is fit for its intended use and stays that way. QLogix follows GAMP 5 (Second Edition) and computer software assurance principles: effort is scaled to the risk of the function, and the evidence is written for an inspector to follow.
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Agentic workflow automation
Agentic workflow automation uses orchestrated AI agents to carry out routine quality work across your systems: gathering, checking, drafting and chasing. Each agent works inside defined guardrails, can draft but not approve, and hands decisions to your people.
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Talk it through with someone who has run a plant
Bring your backlog, your systems map or one investigation that keeps coming back. We will tell you plainly what we would do and what we would leave alone.
In the first meeting we cover
- Your current QMS and how it connects to MES, LIMS and ERP
- Where deviations, CAPAs and change controls slow down
- Whether a readiness assessment makes sense, and what it would cover