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)

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.