comes compliance services (CCS)
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 (CCS)
Ravensburg, Baden-Württemberg, Germany
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.
e-Validation Platform (eVP)
An advanced computer system validation (CSV) framework designed to comply with ISPE GAMP 5 second edition and GAMP GPG Enabling Innovation, built on Atlassian Confluence and Jira.
GxP compliance consulting services
Consulting, coaching, mentoring, and training excellence services for the pharmaceutical, healthcare, and medical device industries to minimize risks, lower costs, and ensure regulatory compliance.
CCS Brochure
Downloadable PDF brochure detailing the compliance services and computer system validation solutions offered by Comes Compliance Services.
Validation
IT and application validation services, computer system validation, and infrastructure qualification according to ISPE GAMP 5 standards.
IT and System Validation according ISPE GAMP 5
Validation services for ERP, MES, CTM, LIMS, DMS, DCS, PLC, cCTD, and other applications across CGMP, GMP, GDP, GLP, GCP, MEDDEV, and GVP environments.
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.
e-Validation Platform (eVP)
An advanced computer system validation (CSV) framework designed to comply with ISPE GAMP 5 second edition and GAMP GPG Enabling Innovation, built on Atlassian Confluence and Jira.
GxP compliance consulting services
Consulting, coaching, mentoring, and training excellence services for the pharmaceutical, healthcare, and medical device industries to minimize risks, lower costs, and ensure regulatory compliance.
CCS Brochure
Downloadable PDF brochure detailing the compliance services and computer system validation solutions offered by Comes Compliance Services.
Validation
IT and application validation services, computer system validation, and infrastructure qualification according to ISPE GAMP 5 standards.
IT and System Validation according ISPE GAMP 5
Validation services for ERP, MES, CTM, LIMS, DMS, DCS, PLC, cCTD, and other applications across CGMP, GMP, GDP, GLP, GCP, MEDDEV, and GVP environments.
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.