Comes-Compliance.com is
About Comes-Compliance.com
CCS provides Auditing Services to pharmaceutical global player in the German speaking area. comes compliance services (CCS) is a small, boutique and highly experienced consulting company specializing in simplifying and streamlining EMEA, FDA, ICH and GHTF quality systems, validation and regulatory compliance requirements. CCS is managed by Markus Roemer.
CCS is the head management of a partner and alliance network called CCS network, in which well recognized companies deliver products and services to the regulated industries.
CCS is the founder and sponsor of IT Pharma Validation Europe organisation, one of the largest validation networks in Europe, which is a world-class recognized organisation in regulatory compliance, validation, project management and consulting services.
Our services encompass the entire compliance and validation project life cycle, and a complete range of IT project services including ERP, MES, LIMS, DMS, eQMS, eCTD, eValidation, Test Management Systems and all types and brands of IT and application systems used in regulated laboratories, manufacturing or medical device production.
We manage and execute full validation projects, including development of validation policies, SOPs, master plans and requirements; development and execution of installation qualifications, operational qualifications and performance qualification; and the performance of individual tasks associated with a client’s validation efforts.
We are dedicated to the pharmaceutical, biological, biotechnology, healthcare and medical device industry. Our consultants are themselves from the industry and have the education, knowledge and hands-on personal experience and validation expertise needed for the challenges facing today’s pharmaceutical operations.
Our mission is to contribute to the success of our clients by providing them with Compliance Management Solutions that will improve their ability to develop, manufacture and deliver drugs and medical devices to market.
We provide excellent project leaders to achieve on-time, on-budget, successful projects. Our project leaders furnish initiative and project consultation to organize and execute work needed to achieve the results expected by our clients. About 80 percent of our business is repeat-business.
comes compliance services is highly experienced in the following IT systems, in terms of design, configuration, implementation, validation, and maintenance services.
Within our CCS competence center for IT solutions we have partnerships and alliances with several highly specialized suppliers and vendors. Regulatory compliant solutions require a stable system platform and design, reliable supplier input, system implementation expertise and knowledge, good practice of documentation and communication, and validation.
All our partner solutions, services, and systems are based on our established project experiences over the last years in many projects.
CCS can help you to:
•Find the right and fitting solution for your business and regulatory requirements. •Choose the appropriate vendor for solutions and services. Reviewing contracts and project mile-stones within an early planning phase. •Design the best project and validation approach. •Set up appropriate teams for system implementation and validation. •make your IT project a success.
Our objective is that your IT project gets a Regulatory Compliant Solution right-first-time, in time and in budget, corresponding to your exact needs and expectations. Profit now from our expertise, an established and professional vendor and business network for the following systems and applications.
