Expertise for GMP Systems and Projects
Inspection & Regulatory
Regulatory Readiness and Inspection Preparation
QMS Design and Review
Design and review of quality management systems to ensure regulatory readiness and effective governance
Focus:
- Design and structuring of the QMS framework
- Definition of GMP-relevant processes and governance
- Gap analysis between existing quality systems and GMP requirements
- Review of management oversight and escalation mechanisms
- Alignment of company-wide quality structures with GMP expectations
GMP Gap Analysis
Structured identification of GMP gaps, regulatory risks and systemic weaknesses
Focus:
- Holistic review of GMP systems and control structures
- Maturity assessment of regulatory governance
- Differentiation between systemic weaknesses and isolated deficiencies
- Cross-functional analysis of compliance gaps
- Development of a prioritised action plan at management level
Regulatory Readiness Assessment
Cross-system evaluation of GMP-relevant systems and interfaces
Focus:
- Assessment of change control, deviation management and CAPA governance
- Assessment of risk management maturity and compliance with ICH Q9
- Review of cross-functional interfaces and escalation pathways
- Assessment of findings and early indicators of quality and compliance risks
- Stress testing of procedural consistency in operational practice
Annex 1 and Contamination Control Readiness
Alignment of governance with Annex 1 requirements and contamination control principles
Focus:
- Maturity and lifecycle governance of the Contamination Control Strategy (CCS)
- Integration of environmental monitoring, utilities and validation controls
- Accountability structures for sterile processes
- Integration into management review processes
- Cross-functional escalation and oversight mechanisms
Audit and Inspection Support
Structured preparation for regulatory inspections and audits
Focus:
- Simulated inspections at system level
- Assessment of inspection readiness at management level
- Development of a consistent inspection narrative
- Review of critical quality trend data
- Simulation of interview and escalation scenarios
Validation & Process
Validation Readiness, Lifecycle Management and Process Robustness
Validation Strategy and Risk Framework
Structured definition of validation priorities, risk logic and control principles
Focus:
- Alignment of the validation strategy with product, process and system criticality
- Risk-based prioritisation of qualification and validation activities
- Alignment of the validation scope with GMP and lifecycle requirements
- Integration of process understanding, control strategy and risk management
- Framework for consistent validation and escalation decisions
Validation Programmes and Master Plans
Development of an integrated validation planning framework for implementation and oversight
Focus:
- Structuring the scope of validation, sequencing and responsibilities
- Aligning validation plans with project milestones and operational readiness
- Integration of equipment, utilities, facilities, processes and computer systems
- Planning logic for resource requirements, interfaces and execution dependencies
- Foundation for coordinated validation oversight and management reporting
Validation Lifecycle Management
Governance of validation activities across all relevant systems and process lifecycles
Focus:
- Lifecycle governance from planning and execution through to ongoing maintenance
- Alignment of validation documentation and outcomes across DQ, IQ, OQ and PQ
- Coordination of periodic reviews, requalification and ongoing validation requirements
- Integration of changes, deviations and CAPA into lifecycle governance
- Transparency regarding validation status, dependencies and critical path risks
Impact of Changes and Validation Control
Assessment of the impact of changes on validation and determination of necessary control measures
Focus:
- Assessment of the GMP and validation implications of technical and process-related changes
- Definition of requalification and revalidation requirements
- Integration of change control with risk assessment and implementation planning
- Review of the impact on systems, equipment, processes and documentation
- Governance of validation-related decision-making and approval processes
Continued Process Verification (CPV)
Strengthening process performance oversight through structured data analysis and regular review
Focus:
- Definition of CPV objectives, parameters and evaluation logic
- Alignment of the monitoring strategy with critical quality attributes and process parameters
- Trend evaluation regarding process consistency, variability and early risk signals
- Integration of CPV results into management review and continuous improvement
- Governance of escalation mechanisms for adverse trends and critical deviations in process performance
Data Integrity & Digital Systems
Risk Assessments for Data Integrity and Digital Systems
Risk Assessments for Data Integrity and Digital Systems
Structured identification of data integrity risks, control weaknesses and compliance gaps in digital systems
Focus:
- Risk-based assessment of data integrity in GMP-relevant systems and processes
- Identification of control weaknesses in data generation, processing, validation and retention
- Assessment of system design, user roles and access governance
- Review of critical interfaces, data flows and hybrid process risks
- Prioritisation of actions based on data integrity and compliance implications
Implementation of ALCOA+
Implementation of ALCOA+ principles in operational controls, system design and day-to-day practice
Focus:
- Integration of ALCOA+ principles into procedures, workflows and system use
- Review of documentation practices and data review routines
- Alignment of user behaviour, training and procedural requirements
- Strengthening controls for traceability, clear attribution and record integrity
- Embedding data integrity requirements in day-to-day GMP operations
Data and System Monitoring
Assessment of governance, monitoring mechanisms and control effectiveness in digital GMP environments
Focus:
- Assessment of monitoring and accountability structures for GMP-relevant data and systems
- Review of periodic evaluations, exception handling and escalation mechanisms
- Alignment of governance roles across business functions, Quality and system owners
- Assessment of monitoring logic for critical records, events and system status
- Strengthening management transparency regarding digital compliance risks and relevant trends
Data Integrity in the Design of Digital Systems
Integration of data integrity requirements into the design, configuration and lifecycle governance of digital systems
Focus:
- Integration of data integrity requirements into system design and specification logic
- Review of configuration principles for traceability and effective controls
- Alignment of user roles, permissions and workflows with GMP requirements
- Consideration of requirements for audit trails, metadata and record retention
- Strengthening lifecycle governance to ensure the sustainable embedding of data integrity
Inspection Readiness for Data Integrity and Digital Systems
Structured preparation of digital GMP environments for regulatory inspections
Focus:
- Assessment of inspection readiness for GMP-relevant computerised and digital systems
- Preparation of system narratives, integrity controls and evidence structures
- Review of critical data flows, audit trail review and the handling of system exceptions and deviations
- Identification of likely inspection focus areas and critical interfaces
- Preparation for inspection interviews and consistent responses to expected system-related questions
Engineering & GMP Projects
GMP-Compliant Design, Qualification Strategies and Effective Project Governance
GMP Design Reviews
Structured review of GMP design requirements, compliance risks and implementation readiness
Focus:
- Review of GMP-relevant design principles for facilities, utilities and equipment
- Assessment of GMP-critical design assumptions and boundary conditions
- Assessment of layouts and material and personnel flows from a GMP perspective
- Identification of design-related risks for qualification and operation
- Alignment of design decisions with GMP expectations and lifecycle requirements
URS Reviews
Assessment of user requirements for GMP relevance, clarity and suitability for qualification
Focus:
- Verification of the completeness, clarity and GMP relevance of the URS
- Assessment of end-to-end traceability from the URS through the design to the qualification documentation
- Identification of ambiguous, missing or unverifiable requirements
- Alignment of the URS structure with the requirements for DQ, IQ, OQ and PQ
- Strengthening the quality of requirements as the foundation for GMP-compliant project execution
Engineering Risk Assessments
Structured assessment of engineering risks affecting GMP compliance, operability and qualification
Focus:
- Identification of engineering risks with potential implications for GMP compliance
- Assessment of technical decisions regarding operability, cleanability and maintenance requirements
- Review of interfaces between design, process requirements and compliance expectations
- Assessment of risk mitigation measures throughout the project and implementation phases
- Prioritisation of engineering risks requiring escalation or additional risk reduction measures
Commissioning and Qualification Strategies
Development of a risk-based strategy for coordinated commissioning and qualification execution
Focus:
- Definition of scope, sequence and responsibilities for commissioning and qualification
- Alignment of the C&Q strategy with project milestones and operational readiness
- Integration of design, testing and documentation logic across all involved disciplines
- Identification of implementation dependencies, handover risks and unclear interfaces
- Coordinated oversight of qualification progress and critical decisions
Project Governance Reviews
Independent review of governance structures, decision pathways and execution oversight in GMP-critical projects
Focus:
- Assessment of governance roles, project accountability and decision-making structures
- Review of escalation pathways, interface clarity and management oversight
- Identification of structural weaknesses affecting schedule objectives and compliance
- Assessment of planning realism, dependency management and execution control
- Strengthening governance and improving project stability