comes compliance services (CCS) in Ravensburg continued double digit growth in 2011 by serving best-practice compliance services and solutions to a wide range of GxP-regulated companies and suppliers. Achieving high levels of customer satisfaction and meeting the expectations & project requirements require that CCS continually monitor and improve compliance strategies and concepts. Key to our business success is the level of customer repeat business and satisfied new customer wins in 2011 – by providing projects On-Time and On-Budget by utilizing highly competent and skilled consultants.
Our CCS Project Examples – successfully executed and finished in 2011:
- Implementation and Validation of Production Systems and SCADA
- Implementation and Validaton of Electronic Batch Recording Systems
- Qualification and Validation of Building Management Systems
- Support and Execution of PQRs and compliance programs
- Validation of ERP, DMS, LIMS, QMS IT-Systems from several vendors
- Training executions (public and in-house) and speaking at several GMP events
- Consultancy PQM Systems: Quality Risk Management implementation
- Audit and Inspection Preparations and Support, Pre-Audits and Action Plans
- Production Quality Coverage and Quality on the Shop Floor concepts
- Execution of Quality Periodic Reviews and Reporting / Trending
- Assessments of GMP and medical device compliance
- Process and Cleaning Validation for different products
- Third Party Audit execution and reporting
- SOP Development, Training Management, and Reality Checks
- Validation and Qualification of laboratory systems
- PAI support and verification, corrective actions planning
- Support of Audit Programs and Concepts
- Implementation and Validation of electronic deviation and CAPA systems
- Annex 11 compliance checks and reporting
- Validation of electronic requirements and test tools / applications
- Support and Execution of Quality Remediation Plans
- Implementation and Qualification of hygienic zones concepts and methods
- Implementation of ICH Q9 and ICH Q10 including training
Contact us now for more details and references at talk@comes-services.com.