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A complete GxP ecosystem.

Let’s digitize your plant

Quality, laboratory, production, cleanrooms, archives, validation: six applications for pharmaceutical sites, built on the same data integrity principles.

Explore the applications

Drag to rotate the model, then choose a building. Tap a building to open its fact sheet.

One building per function

Each application has its own building and can be used alone or with the others.

  • QaLyZa eQMS

    The quality office

    15 modules that cover every aspect of GMP, including change control, deviations, EDMS and training.

    Discover the eQMS

  • QaLyZa LIMS

    The laboratory

    The quality control laboratory, day to day, from sample receipt to the certificate of analysis.

    Discover the LIMS

  • QaLyZa MES

    The production plant

    The electronic batch record, executed on a tablet right at the line, through to batch release.

    Discover the MES

  • QaLyZa EMS

    The controlled environment area

    Monitoring of your controlled environment areas, grades A to D: samples, sensors and excursions.

    Discover the EMS

  • QaLyZa AMS

    The archives

    Qalyza scans and stores your paper documents; you view them remotely, on a web portal.

    Discover the AMS

  • QaLyZa VMS

    The validation department

    Paperless qualification and validation: protocols, manufacturing processes and statistics, from drafting to approval.

    Discover the VMS

  • Lya

    The server room, at the foot of the quality office

    The eQMS AI assistant: your teams ask it their questions, and it answers from your server.

    Discover Lya

What flows between the buildings

All the applications are interconnected. On the model, each exchange follows its own glowing path.

See the platform

  • ERP to MES

    Manufacturing orders.

  • Scales to MES

    Weighings.

  • OPC UA to MES

    Process values from the equipment.

  • LIMS to MES

    Test results.

  • EMS to eQMS

    An excursion raised as a deviation.

  • MES to eQMS

    Batch deviations, with their progress reported back.

  • LIMS and eQMS

    Laboratory and quality data, in both directions.

  • AMS and eQMS

    Quality documents and their archives, in both directions.

  • VMS and eQMS

    Validations and quality records, in both directions.

Each GMP process has its own module

Good Manufacturing Practice (GMP) describes the processes of a pharmaceutical site. Each one is supported by a module, in one of the site's buildings.

GMP processes and the QaLyZa modules that support them
GMP processIn QaLyZa
Change controlICH Q10, EU GMP Chapter 1
  • eQMS Change control
Deviations, corrective and preventive actionsICH Q10
  • eQMS Deviations, CAPA
Out-of-specification resultsEU GMP Chapter 6, 2022 FDA OOS guidance
  • eQMS OOS / OOT investigations
  • LIMS Out-of-specification flagged at data entry
Complaints and recallsEU GMP Chapter 8
  • eQMS Complaints
Self-inspections and auditsEU GMP Chapter 9
  • eQMS Audits
DocumentationEU GMP Chapter 4
  • eQMS Document management
  • MES Electronic batch record
  • AMS Archiving
Personnel and trainingEU GMP Chapter 2
  • eQMS Training
Qualification and validationEU GMP Annex 15
  • VMS Qualification and validation protocols
  • EMS Chamber requalification
Quality risk managementICH Q9
  • eQMS Risk management (FMEA)
Premises, equipment and calibrationEU GMP Chapter 3
  • eQMS Equipment
  • LIMS Equipment blocked if not calibrated
  • EMS Sensor calibration
SuppliersEU GMP Chapters 5 and 7
  • eQMS Suppliers and supplier audits
Production and batch recordsEU GMP Chapters 4 and 5
  • MES Electronic batch record
Quality controlEU GMP Chapter 6
  • LIMS Samples, tests, certificates of analysis
Sterile medicinal products, environmental monitoringEU GMP Annex 1
  • EMS Environmental monitoring
Computerized systemsEU GMP Annex 11, 21 CFR Part 11
  • All applications
  • eQMS Computerized system inventory

The eQMS validation package is provided

Following the risk-based GAMP 5 approach. The eQMS validation package is delivered in French and English, with a kit for your team.

The MES comes with a validation readiness checklist. The LIMS and the EMS document their traceability matrices, from requirement to test.

The documents in the eQMS validation package

  • Validation plan
  • Specifications: user requirements, functions, design
  • Risk assessment
  • IQ, OQ and PQ qualification protocols
  • Traceability matrix
  • Validation report
  • Kit for your team: guide, URS template, customer protocols

Compliance in detail: GMP, Part 11, Annex 11, GAMP 5

The standards, sheet by sheet

There is no Part 11 or Annex 11 certification for software: these texts apply to your organization. Each sheet describes the mechanisms QaLyZa implements to help you demonstrate your compliance.

Dimensioned detail: an electronic signature

Electronically signed by C. MoreauQuality assurance manager

Re-authentication: user ID and password re-entered for every signature (11.200).

Meaning: QA approval

Meaning displayed before signing, and shown on printouts (11.50).

2026-10-20 14:32:07 UTC

Server timestamp, in UTC.

9c2e4f71…7a90c4b1

Fingerprint of the signed content: the signature stays linked to the content it covers (11.70).

Signature registerNever rewritten

Signature register, printed with the record.

  • Account lockout after repeated failures, failed signatures included; in the eQMS, administrators are alerted immediately (11.300).
  • Sessions that expire on their own (11.10 (d)).
  • Electronic signatures cover all six applications: the eQMS, the LIMS, the MES, the EMS, the VMS and the AMS, which signs the handover and return of its originals.
Part 11, on the Compliance page
Standard
21 CFR Part 11
Issuer
FDA
Applications
all six applications

Dimensioned detail: an audit trail entry

DEV-2026-0042Modification: criticality

What: the record and the action, logged by the system itself.

A. BenaliProduction manager

Who: an individual account, never reassigned.

2026-10-20 10:47:30 UTC

When: the server timestamp, in UTC.

Reason: affected batch identified

Why: the reason for the change.

Minor → Major

Before and after: the previous value remains viewable.

  • § 9, audit trail: viewable, filterable, exportable.
  • § 7, storage and backup: encrypted backups and tested restore for the eQMS; audit trail re-verified after a restore for the MES.
  • § 10, change management: tracked versions, Change control in the eQMS.
  • § 12, security: profiles, login and lockout logs.
Annex 11, on the Compliance page
Standard
EU GMP Annex 11
Issuer
European Commission, PIC/S
Applications
all six applications

Elevation: the V-model of the eQMS validation package

Traceability matrix Validation plan Validation report Risk assessment User requirements Functional specification Software design Installation qualification Operational qualification Performance qualification Code and automated tests
  • eQMS validation package provided, in French and English, with a kit for your team.
  • MES: category 5; it comes with a validation readiness checklist.
  • LIMS and EMS: traceability matrices, from requirement to test.
  • Automated tests on every change, in all applications: a change that fails is not deployed.
GAMP 5, on the Compliance page
Standard
GAMP 5
Issuer
ISPE
Applications
all six applications

Schedule: nine principles, nine proofs

The ALCOA+ principles and their evidence in QaLyZa
LetterPrincipleEvidence in QaLyZa
AttributableEvery action carries the name of its author.
LegibleValues, reasons and signatures shown in readable form, and exportable.
ContemporaneousEvery action is timestamped when it happens.
OriginalVersions retained, approved documents never rewritten.
AccurateChecks at data entry and verified calculations.
CompleteNo deletion: a correction is added, with its reason.
ConsistentUniform numbering and timestamps.
EnduringProtected logs, encrypted backups.
AvailableAudit trails viewable, filterable and exportable at any time, including during inspections.
ALCOA+, on the Compliance page
Standard
ALCOA+
Issuers
FDA, MHRA, PIC/S
Applications
all six applications

Plan and readings: a monitoring point in grade A

Grade D Grade C Grade B Grade A PA-A-03 Filling room, grade A Particles ≥ 0.5 µm, at point PA-A-03 Alert 2,900 Action 3,520 EX-2026-0007 opened
  • Rooms classified grade A to D; a grade change is signed and justified.
  • Alert and action limits per monitoring point, with changes signed and kept on record.
  • Excursion opened automatically as soon as a result or reading exceeds its limit; investigation (root cause and impact), then signed QA closure.
  • Trends plotted with their limits; silent sensors flagged.
Annex 1, on the Compliance page
Standard
EU GMP Annex 1
Issuer
European Commission
Application
EMS

Software alone does not make an organization compliant: system validation, your procedures and your infrastructure all play a part. QaLyZa provides the mechanisms and documentation to support it.

Compliance, and what remains your responsibility

Lya answers from your server

Lya is the eQMS assistant: a chat bubble where you ask questions about your records, in everyday language. It runs on your server; no data is sent to a third party.

  • No training on your data.
  • It respects each user's permissions.
  • It cites the numbers of the records it relies on.
  • It answers based on your records; it makes no quality decisions.

Discover Lya

QaLyZa eQMSLya

What is the status of DEV-2026-0042?

DEV-2026-0042, “Temperature deviation in the weighing area,” is at the Investigation stage. A CAPA is linked to it: CAPA-2026-0017, “Requalification of the weighing area probe.”

  • Which deviations are overdue?
  • Which CAPAs are linked to the weighing area?
Fictional example of an exchange with Lya in the eQMS.