Comes Compliance Services
comes compliance services (CCS) is a consultancy company specializing in GxP compliance, offering services in pharmaceutical manufacturing, medical devices, R&D, clinical studies, pharmacovigilance, distribution, and logistics. They combine regulatory expertise with innovative IT solutions to implement modern quality systems, including validation, audits, training, and data integrity. They serve over 50 clients worldwide, providing tailored solutions, audits, and compliance support to ensure processes, products, and systems are inspection-ready and compliant with regulations such as EMA GMP, US FDA, and ISO standards.
Industries
Nr. of Employees
small (1-50)
Comes Compliance Services
Ravensburg, Baden-Wurttemberg, Germany, Europe
Products
Web-based audit database solution
A centralized, web-based audit management tool to plan audits, collect supplier responses via e-forms, store audit reports, track corrective actions and generate quality metrics; accessible to clients, suppliers and audit teams and designed with ready-to-use workflows and multilingual support.
Web-based audit database solution
A centralized, web-based audit management tool to plan audits, collect supplier responses via e-forms, store audit reports, track corrective actions and generate quality metrics; accessible to clients, suppliers and audit teams and designed with ready-to-use workflows and multilingual support.
Services
Consultancy covering validation, quality systems, data integrity, CAPA, change control, and regulatory alignment across GMP, GCP, GLP, GDP and GVP.
Management of third-party, supplier, shared and joint audits including audit planning, on-site and remote execution, shared-cost models, confidentiality arrangements, and coordination with shared-audit databases.
Implementation and configuration of a centralized, web-based audit management system to manage audit programs, supplier submissions, scheduling, CAPA tracking, reporting and integrations with document/ERP systems.
Custom training programs, workshops and coaching on data integrity, validation, audit readiness and quality systems delivered in-house or remotely.
Structured request-for-proposal handling and project scoping services providing fixed-price or time-and-material offers, including project plans and resource estimates.
Consultancy covering validation, quality systems, data integrity, CAPA, change control, and regulatory alignment across GMP, GCP, GLP, GDP and GVP.
Management of third-party, supplier, shared and joint audits including audit planning, on-site and remote execution, shared-cost models, confidentiality arrangements, and coordination with shared-audit databases.
Implementation and configuration of a centralized, web-based audit management system to manage audit programs, supplier submissions, scheduling, CAPA tracking, reporting and integrations with document/ERP systems.
Custom training programs, workshops and coaching on data integrity, validation, audit readiness and quality systems delivered in-house or remotely.
Structured request-for-proposal handling and project scoping services providing fixed-price or time-and-material offers, including project plans and resource estimates.
Expertise Areas
- Computerized system validation
- Data integrity and data governance
- Audit program management and shared audits
- Supplier qualification and quality agreement development
Key Technologies
- Risk-based validation frameworks
- Electronic validation platforms
- Web-based audit management systems
- E-form / e-postal audit execution
News & Updates
Participation in the GMP Conference 2017 with training and workshops.
Multiple training sessions and events on GMP, validation, and compliance topics.
Information and sources on data integrity from EMA, PIC/S, and WHO.
Guidelines and standards for computer system validation in pharma.
Participation in the GMP Conference 2017 with training and workshops.
Multiple training sessions and events on GMP, validation, and compliance topics.
Information and sources on data integrity from EMA, PIC/S, and WHO.
Guidelines and standards for computer system validation in pharma.