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Our latest recommendation: How to find and setup a shared audit with other companies and QPs? At our CCS Audit Service Center we do reference to the “QPSHARE” database, which is provided to the members of the European QP Association (external link). The European QP Association initiated a database comprising shared audits information between Qualified Persons. In a first step QP . . . → Read More: Shared Audit Setup with QPShare 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 . . . → Read More: CCS looks back on a successful 2011 comes compliance services joined the MESA International organisation: MESA (Manufacturing Enterprise Solutions Association) International is a global community of manufacturers, producers, industry leaders and solution providers who are focused on improving Operations Management capabilities through the effective application of technology solutions and best . . . → Read More: CCS joins MESA.org as member German Translation Annex 11 – Deutsche Übersetzung Anhang 11 – Revision 2011 by zlg.de – EFG 11: Download: EU_GMP_Leitfaden_Anhang_11_DE_v2 (Annex 11 – Deutsch) Download: EFG_votum V11003 (Anforderungen an elektronische Unterschriften und Handzeichen) Contact us for more information, gap assessments, front-end studies . . . → Read More: German Translation Annex 11 – Deutsche Übersetzung Anhang 11 – Revision 2011 CCS membership at bwcon 2011: Baden-Württemberg connected – Read more… Baden-Württemberg: Connected e.V., or bwcon for short, is the top business initiative promoting Baden-Württemberg as a high-tech location. As one of the most successful European technology networks, bwcon connects more than 460 companies and research institutes. Currently more than 4,600 experts are benefiting from systematic networking via . . . → Read More: bwcon 2011: CCS networking GMP Verlag published the new ‘GMP Paperback CSV’ in July 2011, written by Markus Roemer. It contains a current view on Annex 11 – Revision 2011, basic requirements of ISPE GAMP 5, quality risk management, and up-to-date validation strategies and special topics (e.g. ERP, Excel, data migration, and much more). Read more: GMP LogFile #9 from July 2011 (German) This . . . → Read More: GMP Paperback Computer System Validation Revision 2011 Article published on Pharmaceutical Technology Europe – New Annex 11: Enabling Innovation - Read it online . . . → Read More: Annex 11 – “Computerised Systems” – Revision 2011 – Implementation Read the CCS brochure online: Open publication – . . . → Read More: CCS brochure – online How systems can support compliance in a regulated environment: The webinar will consider the evolution in the development and delivery of compliance related document management systems using the challenges of managing Quality Management System (QMS) documents. It will look at the advantages of using documents in a SharePoint environment for working examples. Over the last decade, the requirements . . . → Read More: The Evolution of Electronic Document Management Systems by GxPi EMA published today the new GMP Annex 11 – Computerised Systems – revision January 2011 – download your copy here: PDF The deadline for coming into operation of the new Annex 11 is 30th June 2011. Find here also the new EudraLex Chapter 4 – Documentation: PDF Basic Principle of . . . → Read More: NEW ANNEX 11 – Computerised Systems – revision January 2011 – CCS solution package  Comments are closed  CCS events, CCS inside, CCS links, CCS news  - Computerised Systems, ANNEX 11, EUDRALEX, revision January 2011 |
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