WAICE

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Industries / Pharma & life sciences

AI designed for GxP environments, from R&D to batch release.

Pharmaceutical companies, biotechs, contract manufacturers and bioprocessing suppliers work under some of the strictest quality requirements. WAICE helps them structure knowledge, validate computerised systems and deploy AI with the traceability inspectors expect.

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Challenges

What teams are dealing with.

Heavy quality documentation

Procedures, batch records, deviations and CAPAs keep quality teams constantly busy.

System validation

Every computerised system must be qualified and kept in a validated state.

Siloed functions

R&D, quality, production and regulatory affairs use different tools and vocabularies.

Sensitive data

Health data, trade secrets and intellectual property require strict control of AI use.

What WAICE brings

Five angles, one method.

Business

Quality, regulatory affairs, production and R&D

  • Deviation and CAPA handling
  • Regulatory dossier preparation
  • Scientific and regulatory watch

Data & AI

Batch records, LIMS, QMS, clinical data and quality documentation

  • Data integrity (ALCOA+)
  • Quality knowledge base
  • Sourced document search

Infrastructure & applications

LIMS, QMS, MES, quality document management and ERP

  • Computerised system validation (GAMP 5)
  • Lab and production system integration
  • Support of validated systems

Cybersecurity

Intellectual property, health data and production sites

  • Access and AI usage control
  • Health data protection
  • Production network segmentation

Regulation & compliance

GMP, Annex 11, 21 CFR Part 11, GAMP 5, GDPR

  • Traceability and audit trail
  • Validation of AI uses
  • Documentation for inspections

If AI becomes part of a medical device or clinical decision support, further requirements apply, such as the EU Medical Device Regulation.

Use cases

Where to start.

Deviation handling

Find similar deviations, their causes and related CAPAs to speed up investigations.

Measured by

  • time to closure
  • recurrence
  • overdue deviations

Inspection readiness

Quickly retrieve the evidence and documentation inspectors ask for.

Measured by

  • evidence retrieval time
  • audit observations
  • missing documents

Quality document assistant

Query procedures and standards in plain language, with source and version cited.

Measured by

  • search time
  • repeated questions
  • adoption

Assisted regulatory writing

Prepare first drafts from validated data, reviewed by experts.

Measured by

  • drafting time
  • review cycles
  • submission lead time

Team

Profiles we deploy.

IT profiles today, joined over time by business experts from each industry.

  • Quality IT project manager
  • Validation consultant (CSV / CSA)
  • LIMS / QMS consultant
  • Data engineer
  • AI consultant
  • Validated systems support engineer

Transformation programmes

Start small, be ready to scale.

Our founder has worked on large-scale transformation programmes in international groups. WAICE starts with a controlled scope (one site, one function, one use case) and then scales up with a network of selected consultants and experts.

  • A first scope delivered within weeks
  • Governance designed for scale from day one
  • Teams built around your needs, IT and business

How we start

Four steps, at your pace.

  1. 01

    Diagnostic

    A one-hour or half-day session to qualify a use case, a risk or a decision.

  2. 02

    Scoping

    Scope, data, systems, regulatory constraints and success indicators.

  3. 03

    Delivery

    Development, integration and deployment, alongside your teams.

  4. 04

    Run

    Maintenance, support and continuous improvement, with clear service commitments.

Other industries

Aerospace & defence

Airworthiness, configuration, technical documentation: making AI useful where every decision must be traceable.

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Chemicals & petrochemicals

Seveso sites, process units, maintenance: securing operations and building on experience.

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Energy & critical networks

Grids, substations, generation: keeping AI maintainable in infrastructure that never stops.

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Logistics & supply chain

Ports, warehouses, transport: making flows, data and documents more reliable.

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Manufacturing

Production, quality, maintenance: connecting the shop floor with enterprise systems.

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Banking & insurance

Compliance, customer relations, risk: controlled AI in a highly regulated industry.

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Start with a concrete case.

Tell us about a decision, a process or a system you want to improve. We will tell you honestly whether AI is the right answer.

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