Quality operations

Technical and operational support within your quality and manufacturing teams.

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// What we do

Quality operations services

Quality systems and projects

Belgian affiliate set-up
Quality projects and project management
QMS optimisation
eQMS and digitalisation
Custom quality applications

Technical quality

Sterility assurance
Risk assessment
Validation and qualification
Site conformance
MS&T and technology transfer

Assurance and development

Audits and supplier qualification
Inspection readiness
Training, mentoring and coaching
Process monitoring and quality performance

// Our expertise

Quality operations scope

QMS and operational governance

Deviations, root cause investigations and CAPA effectiveness
Change control, SOP lifecycle and training deployment
Belgian affiliate set-up and quality project management
Backlog recovery, closure rates and monthly quality dashboards

Qualification and validation

Equipment and utility qualification: IQ, OQ and PQ
Process validation, CPV, cleaning and hold time validation
Validation Master Plan development or restructuring
CSV: URS, risk assessment, tests and summary reports
Data integrity, audit trails and remediation plans

Sterility and contamination control

CCS assessment, design, implementation and remediation
Facility, process and cleanroom risk assessments
Environmental monitoring strategy and trend analysis
Aseptic process performance and APS/media fill oversight

MS&T and site conformance

Technology transfer from R&D to commercial scale
Process robustness, scalability and line stabilisation
Site, facility, process and documentation gap assessments
Lean improvement and operational efficiency
Transfer roadmaps, remediation and monitoring checkpoints

Audits, suppliers and risk

Internal audit programmes and supplier qualification
Audit preparation, findings and corrective-action follow-up
Risk assessments, registers and control effectiveness
Vendor governance, quality metrics and performance reviews

Inspection readiness

Gap and risk review, walkthroughs and readiness assessment
Evidence mapping, data integrity and mock inspections
Operator, SME, QA and leadership preparation
Inspection-day coaching, escorts and document-request flow
EU GMP/GDP, FDA/PIC/S contexts; 483 responses and CAPA follow-up

Digital quality and applications

eQMS workflows: documents, events, CAPA, changes, audits and suppliers
Custom tools for risk, validation, batch evidence and monitoring
User requirements, roles, data and traceability
Implementation, validation, training and reporting models

Training and mentoring

GMP/GDP, QP responsibilities and inspection preparation
CCS, validation, process monitoring and data interpretation
On-site or remote delivery tailored to the audience
Specialist mentoring, practical exercises and documented handover

// Inspection readiness

Key features

Assessment and evidence

Pre-inspection gap and risk assessment
Mock inspections for EU GMP, GDP, FDA and PIC/S contexts
Documentation, data integrity and audit trail review
Facility and process walkthroughs

People and inspection support

Inspection preparation for operators, SMEs, QA and leadership
Inspection-day coaching, escort roles and document flow
Observation and deficiency response support
Response templates and CAPA follow-up

// Our approach

Inspection readiness in four steps

Assessment

Gap assessment, risk review and readiness scoring.

Preparation

Document organisation, evidence mapping, mock inspections and staff training.

Execution

SME coaching, document-request control and real-time inspection support.

Response and improvement

Observation responses, CAPA planning and follow-up to strengthen the quality system.

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