comes compliance services
comes compliance services (CCS) is an independent and premier consultancy service provider for the regulated industries. Our consultancy concepts and expertise is based on an inimitable combination of regulated expert knowledge and innovative IT solutions.
CCS offers different concepts, strategies, and methods for compliance management: Quality System / PQS integration (GLP, GCP, GMP, GVP, GDP, MEDDEV), GxP datability integration and data governance, audits and inspections management, IT / application validation (ISPE GAMP 5) incl. Annex 11 and 21 CFR Part 11 programs, software development life cycle e.g. according IEC 62304, Audit Service Center (third party audits / shared audit programs), Project Management, Pharma 2.0 implementation (Electronic Batch Recording, Paperless Lab, ELN, Data Warehouse), and IT Infrastructure Qualification & Security.
CCS is bringing their services of excellence to four of the top 5 international pharmaceutical companies and more than 40 local clients.comgoetz