# QLogix

> QLogix (QLogix LLC) is a QMS implementation and integration partner for life sciences. It selects, configures, validates and connects quality management systems for emerging and mid-size biotech and pharma, CDMOs and CMOs, and 503B outsourcing facilities, and adds AI workflows that draft, trend and flag while qualified people review and approve. Based in Newport Beach, California; on site across Southern California and remote elsewhere.

Key facts:
- AI is decision support only: it drafts, summarizes, trends and flags. Review, approval and batch disposition stay with qualified personnel, and AI contributions are recorded in the audit trail.
- Platform-agnostic: works with the client's existing QMS and its integrations with MES, LIMS and ERP.
- Frameworks: 21 CFR Part 11, 21 CFR Parts 210/211, 21 CFR Part 820 (QMSR), EU GMP Annex 11, EU GMP Annex 22 (draft), ICH Q9(R1), ICH Q10, GAMP 5 (2nd ed.), FDA CSA guidance.
- Engagements start with a QMS readiness assessment: processes, systems, data flows and backlog, with baseline metrics agreed before anything changes.

## Services

- [QMS digitization](https://qlogix.ai/services/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. Includes: Deviations, CAPA, Change control, Complaints, Document control, Training, Supplier quality, APR/PQR.
- [AI-assisted investigations](https://qlogix.ai/services/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. Includes: IS / IS NOT problem statements, Fishbone, 5-Whys, CAPA effectiveness checks.
- [Connected quality data](https://qlogix.ai/services/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. Includes: MES, LIMS, ERP, Batch records.
- [Validation of AI-enabled systems](https://qlogix.ai/services/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. Includes: Intended use, Risk assessment, Test evidence, CSA.
- [Agentic workflow automation](https://qlogix.ai/services/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. Includes: Orchestrator and specialist agents, Least-privilege access, Draft-only writes, Human approval gates, Audit trail.

## Frequently asked questions

- **What does QLogix do?** QLogix is a QMS implementation and integration partner for life sciences. It selects, configures, validates and connects quality management systems for biotech, pharma, CDMOs and 503B facilities, then adds AI workflows that draft, trend and flag while qualified people review and approve.
- **Who does QLogix work with?** Emerging and mid-size biotech and pharma companies moving from paper or hybrid systems to a validated, connected QMS; CDMOs and CMOs managing several client quality agreements on one system; and 503B outsourcing facilities meeting cGMP expectations with lean teams and high batch volume.
- **Does the AI make quality decisions?** No. AI drafts, summarizes, trends and flags. Review, approval and batch disposition stay with qualified personnel, and each AI contribution is recorded in the audit trail.
- **Do we have to replace our QMS?** Usually not. We start from what you have and recommend a change of platform only when the assessment shows the current one cannot meet the need.
- **How are AI functions validated?** With a risk-based approach: defined intended use, risk assessment, documented testing against acceptance criteria, and change control for any model update.
- **Which regulations and frameworks do you work to?** 21 CFR Part 11, 21 CFR Parts 210 and 211, 21 CFR Part 820 (QMSR), EU GMP Annex 11, the draft EU GMP Annex 22, ICH Q9(R1), ICH Q10, GAMP 5 (Second Edition) and FDA's computer software assurance guidance.
- **Which platforms do you work with?** We are platform-agnostic and work across the major QMS platforms and their integrations with MES, LIMS and ERP.
- **How does an engagement start?** Most clients start with a QMS readiness assessment covering processes, systems, data flows and backlog. Baseline metrics such as deviation cycle time, backlog age, recurrence and right first time are agreed before anything changes.
- **Where do you work?** We are based in Newport Beach and work on site across Southern California, with remote delivery elsewhere.

## Blog

- [FDA's seven-step credibility framework for AI, in plain terms](https://qlogix.ai/blog/fda-ai-credibility-framework) (AI in quality, updated 2026-10-12): FDA's draft guidance asks sponsors to show that an AI model is credible for a specific context of use. The effort scales with model risk: how much the model's output drives the decision, and how serious a wrong decision would be.
- [AI in drug manufacturing: where FDA stands and what to build for](https://qlogix.ai/blog/ai-in-drug-manufacturing-fda) (Manufacturing science, updated 2026-10-12): FDA has no final guidance written only for AI in drug manufacturing. It has a 2023 discussion paper naming five open areas and a 2025 draft framework that covers manufacturing models. Together they show what a process model has to prove.
- [AI-enabled medical devices: what FDA's list and guidance show](https://qlogix.ai/blog/ai-enabled-medical-devices-fda) (Medical devices, updated 2026-10-12): FDA's public list counted 1,614 AI-enabled medical devices through June 2026, about three in four of them in radiology. Two documents shape how they are built and changed: the final guidance on predetermined change control plans and the draft guidance on lifecycle management.
- [Robotics in aseptic manufacturing: what Annex 1 expects](https://qlogix.ai/blog/robotics-aseptic-manufacturing-annex-1) (Manufacturing science, updated 2026-10-12): The revised EU GMP Annex 1 names robotic systems, with isolators and RABS, as technologies to consider for protecting sterile products. Taking the operator out of the critical zone removes the largest contamination source and moves the quality work to design, software and data.
- [EU GMP Annex 22: what the draft AI annex asks of GMP manufacturers](https://qlogix.ai/blog/eu-gmp-annex-22-ai-draft) (Regulatory updates, updated 2026-10-12): Draft Annex 22 is the first GMP annex written for AI. It allows static, deterministic models in critical GMP applications, keeps generative AI out of them, and asks for a defined intended use, independent test data and ongoing monitoring.
- [Computer software assurance: what FDA's final guidance changes for validation](https://qlogix.ai/blog/computer-software-assurance-final-guidance) (Validation, updated 2026-10-12): FDA's final guidance on computer software assurance replaces test-everything validation with effort matched to risk. Features that could compromise safety get scripted testing; the rest can be covered by unscripted testing and supplier evidence.

## Pages

- [Home: QMS implementation for life sciences](https://qlogix.ai/): QMS selection, configuration, validation and integration for biotech, pharma, CDMOs and 503B facilities, with AI that drafts and flags while qualified people decide.
- [Services](https://qlogix.ai/services): QLogix services: QMS digitization, AI-assisted investigations, connected quality data, validation of AI-enabled systems and agentic workflow automation.
- [QMS digitization](https://qlogix.ai/services/qms-digitization): Move deviations, CAPA, change control, complaints, documents and training from paper or hybrid systems to a validated electronic QMS, configured to your SOPs.
- [AI-assisted investigations](https://qlogix.ai/services/ai-assisted-investigations): AI drafts the problem statement, root cause candidates and CAPA plan from your records. Investigators and QA review, edit and approve, with a full audit trail.
- [Connected quality data](https://qlogix.ai/services/connected-quality-data): Link your QMS to MES, LIMS, ERP and batch records for trending, recurrence detection and earlier signals, with validated interfaces and data integrity controls.
- [Validation of AI-enabled systems](https://qlogix.ai/services/validation-of-ai-enabled-systems): Risk-based validation of AI functions in GxP systems: intended use, risk assessment, test evidence against acceptance criteria and change control for model updates.
- [Agentic workflow automation](https://qlogix.ai/services/agentic-workflow-automation): AI agents that gather, check, draft and chase across QMS, LIMS, MES and ERP, inside guardrails: least-privilege access, draft-only writes and human approval.
- [Blog](https://qlogix.ai/blog): QLogix blog: regulatory updates on AI in GxP, FDA and EU guidance explained, and how life sciences quality teams adopt and validate AI.
- [Request a meeting](https://qlogix.ai/contact): Talk to QLogix about QMS implementation, AI-assisted investigations and CAPAs, connected quality data and validation of AI-enabled systems.

## For language models

- [Full text of every public page](https://qlogix.ai/llms-full.txt)
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## Contact

- Email: contact@qlogix.ai
- Phone: +17146639012
- Address: 5000 Birch Street, West Tower, Suite 3000, Newport Beach, CA 92660