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. CCS has experience on the following solutions including, but not limited to:
- ERP – Enterprise Resource Planning systems are for the most of our customers the central IT system. We have validated different ERP solutions, from small to global solutions and different function sets and set ups including warehouse management systems, document and quality management, manufacturing integration and intelligence, data warehouse and others. Whichever solution you are using or planning to use in future, get into contact with us now to assure a compliant ERP system running in your IT infrastructure.
- MES – Manufacturing Execution Systems are often used in the regulated industries as Electronic Batch Recording (EBR) systems, where regulatory compliance is of major importance. Also the implementation and configuration requires special subject matter experts to meet complex process requirements with deep system knowledge. We can provide these rarely existing resources for different solutions in the market. Our validation approach in this field was growing over years and has an outstanding format.
- LIMS – Laboratory Information Systems experts have an excellent knowledge about the laboratory processes and the configuration of such systems. Most systems are highly configurable providing traceability and records to the end-users. We have validated several different local and global LIMS systems including Laboratory Automation and Interfacing. Our experience and knowledge regarding LIMS and Paperless Lab is one of our core competencies.
- DMS – Document Management Systems are used for the management of SOPs, protocols, specifications, records, quality agreements, audit reports and more. It helps you manage documents types/formats and setup and track reviews & approvals. Our partner offers also DMS on the platform of MS SharePoint. At CCS we have successfully executed different DMS / eCTD projects and implementations including validation containing electronic records and signatures.
- eQMS – electronic Quality Management Systems (e.g. Change Control / CAPA / deviations / eCTD) including Training Management System are getting more and more implemented by our customers; some are combined with MES or DMS solutions or are integrated to ERP solutions. Beside of the technical implementation we are experts on the quality management processes itself, helping our customer being able to change from paper-based to electronic processes. Validation, integration, implementation and the final acceptance of the end-users are our part of these project realisations.
- SCADA / PCS / PLC systems are the more classical validation projects, depending on the size and extend of the individual process solution. Our deep understanding of such solutions helps us to find the right qualification and validation approach for each implementation. Our experts worked over years with the most common vendor solutions for process automation.
- Clinical Systems (Clinical Safety, Trial and Data Management) are used in the GCP area and require special validation and compliance concepts. At CCS we bring together system experts and validation specialist to fulfil your needs and requirements for CROs, sponsors, IT departments, and quality assurance. Our partner for Clinical Data Management systems offer hosting, training, and consulting on the basis of the market leader product’s platform.
- Clean room technology and systems (monitoring) are required by the pharmaceutical industry in different areas and functions. Our solution partners are offering qualified clean room IT solutions and concepts, and different types of monitoring systems (microbiologic, particles, etc.). These special clean room experts have excellent knowledge and experiences and are involved to other IT project areas like validated EBR.