CCS event sponsoring of bwcon: Fachforum “Auf dem Weg zur Personalisierten Medizin – Herausforderungen und Potenziale für die IT”

comes compliance services is sponsoring the bwcon (Baden-Württemberg: Connected ) event for personalized IT medicines.

When: 17. March 2011, 10:00 – 16:15

Where: Nycomed, Byk-Gulden-Str. 2, 78467 Konstanz, Germany

Join us: More information (in German) and how to join the event: OPEN LINK

when IT comes to compliance…
comes compliance services

NEW ANNEX 11 – Computerised Systems – revision January 2011 – CCS solution package

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
  • Report “New Annex 11” in German from the GMP Verlag:  Info

Basic Principle of the new Annex 11 (Ref.: annex11_01-2011_en):

 This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.

The application should be validated; IT infrastructure should be qualified. 

Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process  control or quality assurance. There should be no increase in the overall risk of the process.

Contact now CCS for the new Annex 11 implementation package for efficient and compliant integration:


CCS lecture at the University of Albstadt Sigmaringen

CCS was giving a lecture at the Hochschule Albstadt Sigmaringen (University – pharmaceutical Technology). Mr. Markus Roemer was giving to the students an overview of different aspects of Pharma 2.0 methods and current industry thinking & approaches.

The implementation of electronic systems, which are using electronic signatures, e.g. for batch recording, lab management, eCTD, and document management systems, require a well balanced approach of implementation and validation.

CCS sponsored the PDA Europe Conference – Parenterals 2010

comes compliance services was sponsoring the PDA Event:

PDA Europe Conference – Parenterals 2010 – Integrating Process, Technology and Regulation, 26-28 October 2010 in Berlin, Germany.

The visitors’ feedback of the conference was very positive – excellent speakers, good speach topics, well organized, opportunity to exchange information and ideas.

Feel free to contact us today at  for more information and our CCS solutions.


source: BioLago e.V.

comes compliance services (CCS), exhibitor at the BIOTECHNICA in Hannover/Germany, presented compliance management solutions to visitors at our event booth. Pharma 2.0 approaches and solutions, IT validation management, Audit Management Services, and regulatory compliance integration offered and delivered by CCS were clearly represented. Mrs. Schmid from CCS said: “A lot of visitors were asking about modern and smart solutions, as we have it in our CCS compliance programs”. Together with the BioLago team, CCS was able to show holistic innovation strategies that enable our customers to fulfill regulatory requirements and come up to the challenges of today’s business.    

More than 9,500 visitors from 40 different nations attended BIOTECHNICA to find out about the latest biotechnology trends in the fields of healthcare, food production, industry, environmental protection, lab equipment and bioinformatics – as well as to transact new business deals (source: BIOTECHNICA – visit

Audit Service Center Upgraded at

comes compliance services (CCS) has upgraded its audit management services on a seperate domain:

The new web site contains an entire overview of the audit management and related tools, which are totally integrated in the process work flows provided by CCS.

The Audit Service Center (ASC) is an independent provider of value-added regulatory quality and audit management services. Starting with the existing compliance programs of our clients we optimize such programs and manage quality audits of manufacturers of materials, products, components, and services providers, in GMP, GCP, GDP, GLP regulated industries such as pharmaceuticals, biologics, medical devices, cosmetics, dietary supplements.

Our team of highly dedicated quality experts delivers to our clients actionable strategic decision systems, improved supply chain processes and inspection readiness. The Audit Service Center implements tested and proven strategies, tools and methods to cut costs and increase profitability of  compliance and audit programs.

Our compliance projects ensure that supply chain requirements meet quality management support, be it for finding a second source of material or component supply, collaborating with suppliers on quality aspects, or investigating suitable outsourcing options. We create the “vendor to partner” dynamics required for improving products and reducing deficiencies.   

Visit now: to get more information and news about audit and CAPA management, supplier chain optimization, shared audits, and other compliance service options.

Pharmaceutical Technology Europe, Jul 1, 2010: CCS Product Showcase

Read in the July issue of  the magazin Pharmaceutical Technology Europe (PTE) about the CCS eValidation concepts and solutions – Product Showcase.

Digital version:

Pharmaceutical Technology Europe (PTE) reports on developments in European pharmaceutical/biopharmaceutical development, manufacturing, and quality assurance and control. Providing technically focused peer-reviewed editorial, opinion, trends and analysis, PTE assists readers in their decision-making and implementation of best practice.