The company provides consulting services to companies in the life science sector, particularly in the areas of: computer system validation, qualification of environments and equipment, calibration of measuring instruments, engineering and digitization of processes, and project management. Additionally, the company also offers services in the qualification of controlled contamination departments and compliance with GxP regulations.
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Consulting for life-science companies on GMP compliance and process improvement; focus areas in CSV, C&Q, calibration, engineering, digital innovation, cybersecurity & NIS2 and GMP consulting.
Audit
Audits for GxP compliance and supplier assessment; CSV and IT system provider audits to review software and IT service providers.
Calibration
Calibration of measuring instruments with ISO report, periodic calibrations, test procedures, on-site assignments at the customer, and a calibration laboratory for instrument inspection and adjustment.
CSV & Data Integrity
Validation of computer-assisted systems, ensuring data integrity and GMP compliance; URS, IQ/OQ/PQ, periodic review, audit trail review and compliance assessment.
Commissioning & Qualification
Qualification of equipment and utilities according to EU GMP Annex 15; risk-based approach, HVAC, clean rooms, utilities, production and packaging lines, and thermal mapping.
Engineering
Engineering consulting for life-science projects; feasibility studies, URS, GMP impact assessment, layouts, procurement, site coordination, commissioning, qualification and handover.
Project management
Project management for complex life-science projects; goal definition, planning, resource and budget control, supplier coordination, risk management, and support for commissioning, qualification and validation.
Digital innovation
Digitalization projects, software selection and business intelligence; process analysis, solution evaluation, roadmaps, implementation and dashboards based on data from files or databases.
Cybersecurity & NIS2
Advisory on NIS2 compliance and NIS2/GxP multicompliance; cybersecurity governance gap analysis, harmonised procedures, implementation of requirements and periodic reviews.
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