# QMS digitization for life sciences
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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## What we configure
The core quality processes, set up as connected workflows rather than separate forms, so a deviation can open a CAPA, a CAPA can open a change control, and each one links back to the records behind it.
- Deviations and investigations
- CAPA, with effectiveness checks
- Change control
- Complaints
- Document control and training
- Supplier quality
- Annual product review (APR/PQR) data

## How the work runs
We start with a readiness assessment of your processes, systems, data flows and backlog, and agree baseline metrics before anything changes. Platform selection follows from that assessment. We are platform-agnostic, and where your current QMS can meet the need we configure and connect it instead of replacing it.
Configuration, integration and risk-based validation run together with SOP updates and training, so the system goes live with procedures that describe how it is actually used.

## What makes it hold up in an inspection
- Electronic records and signatures set up to meet 21 CFR Part 11 and EU GMP Annex 11
- Audit trails that show who changed what, when and why
- Data integrity to ALCOA+ expectations
- Validation evidence scaled to risk, following GAMP 5 (Second Edition)

## Your qualified people decide
- Platform choice and configuration decisions are reviewed and approved by your quality unit.
- Workflow approvals, dispositions and signatures stay with the named, qualified people in your procedures.

## Frameworks this work is built to
- 21 CFR Part 11
- 21 CFR Parts 210/211
- 21 CFR Part 820 (QMSR)
- EU GMP Annex 11
- ICH Q10
- GAMP 5 (2nd ed.)

## Included
- Deviations
- CAPA
- Change control
- Complaints
- Document control
- Training
- Supplier quality
- APR/PQR

## Questions about QMS digitization

### Do we have to replace our current 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.

### Which QMS platforms do you implement?

We are platform-agnostic and work across the major QMS platforms and their integrations with MES, LIMS and ERP. The platform is chosen in the assessment, based on your size and product type.

### What happens to our paper and legacy records?

The assessment identifies which records have to be migrated, which can stay in their original form under your retention procedure, and how the migration will be verified.

### Who is QMS digitization for?

Emerging and mid-size biotech and pharma companies moving to a validated QMS ahead of clinical or commercial scale, CDMOs and CMOs running several client quality agreements on one system, and 503B outsourcing facilities with lean teams and high batch volume.

## Related services
- AI-assisted investigationsThe AI drafts. Your investigators and QA decide.
- Connected quality dataYour QMS linked to plant and lab systems for trending, recurrence detection and earlier signals.
- Validation of AI-enabled systemsRisk-based validation following GAMP 5 (Second Edition) and computer software assurance principles, documented for inspection.
- Agentic workflow automationOrchestrated agents that take on routine quality work across your systems: gathering, checking, drafting and chasing. Each one works inside defined guardrails and hands decisions to your people.

## 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.
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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

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Source: https://qlogix.ai/services/qms-digitization
QLogix · contact@qlogix.ai · +17146639012