Stay updated with our CCS Android App: Download
Installation: Right-click on the download link “save target as” – save and unzip the file on your PC, transfer and install it on your Android SmartPhone.
You will automatically receive current news and information from CCS services, events, and news including our validation network updates.
GxPi works upon the principal that complex issues can be simplified to deliver long term business benefit, better efficiencies and cultural change. We achieve this through a combination of products and services designed specifically for compliance requirements in the life sciences sector. GxPi’s products, x-docs™ and x-train™, provide enterprise grade electronic Document, Content and Compliant training solutions. GxPi’s services cover all aspects of regulatory compliance (GMP, GAMP, GLP, GEP, GCP, GDP), qualified person (QP), quality assurance (QA), and validation particularly with Computerised and Information Technology (IT) systems. (For more information, please visit www.gxpi.com )
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 Association members were asked to submit data about their suppliers using standardised Excel sheets, including name, country, address as well as the relevant products (APIs and excipients). These data were used to identify those suppliers more than one QP were interested in and to inform the QPs who named the supplier in question. Based on this information the QPs had the option to set up a joint audit of the supplier, e. g. by one of the QPs or by a third party, and to share the information. The approach of this project is very similar to that of a pilot project that was initiated by different authorities (e. g. FDA, EMA, EDQM, TGA) to identify those companies more than one authority wants to inspect. As a consequence, one authority might conduct an inspection and share the results with other partners.
The QPSHARE database displays potential suppliers more than one QP is interested in. Members of the European QP Association are able to identify suppliers and the number of QPs interested in auditing the supplier. Confidentiality will be maintained as the names of the QPs will not be displayed. If a member would like to contact the QPs related to a certain supplier, a button allows the member to send an automatic message to the other QPs. Only if the QPs who receive the message are interested they may disclose their identity and contact the colleague. Read more about QPSHARE.
If a common shared audit is found the audit plan, execution and reporting might be managed and controlled by the independent Third Party of Audit Service Center at CCS.
Contact us today at: contact@auditservicecenter.com or talk@comes-services.com
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:
Contact us now for more details and references at talk@comes-services.com.
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 practices.
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 at: talk@comes-services.com
Meet us at the ISPE DACH Affiliate Event (21. / 22. November 2011) in Biberach, Germany.
CCS is sponsoring the Event “UNI meets Pharma” in Konstanz, Germany. This is the third time that the event will be hosted in Konstanz at the University and organized by BioLAGO. These events always offer good opportunities to meet interesting people with different backgrounds and to network.
Find more information:
When: Monday, 19. September 2011; 15.30 Uhr
Where: Universität Konstanz, Hörsaal R 513
Or contact us directly at: talk@comes-services.com
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 version of the paperback book is written in German language – the English version will be issued in September 2011.
Go and visit the PTS Training event “Pharma 2.0”:
– Electronic Batch Recording
– Document Management and Control (eDMS)
– Data Warehouse and Management
– IT Service Management
– Paperless Lab
– eValidation and Test Management
– eCTD and GCP solutions
– new regulatory requirements (EU Annex 11, US-FDA 21 CFR Part 11)
