bwcon 2011: CCS networking

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 the bwcon hub. The added value generated by bwcon is to be found in the possibilities offered by new cooperation projects and connections.

GMP Paperback Computer System Validation Revision 2011

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.

The Evolution of Electronic Document Management Systems by GxPi

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 of organisations around the implementation of compliance related systems have evolved, which has significantly changed the relationship between the people, process and technology.

The tendency now in the experienced organisations (those where EDM is in its 2nd or 3rd generation) is to implement a configurable platform, providing a set of functionality to support the users but not to make the system wholly responsible but operate in conjunction with the working processes and the decisions made by the users themselves. This change can be loosely described as a rebalancing of the people-process-technology triangle, which is often used to describe the implementation of systems.

This evolution has resulted in advantages in terms of usability, acceptability and reduced total cost of ownership in ensuring GxP compliance. READ MORE

REGISTER NOW

23 March 2011 at 15:00 GMT

contact: atoepsch@gxpi.de

 

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: talk@comes-compliance.com

  

MS Excel Spreadsheet Validation – New Focused Solution Packages (FSP) by CCS

CCS introduces its new Focused Solution Package for MS Excel Validation. This fixed price offer contains a full package for covering the validation of spreadsheets and rapid integration on customer sites:

  • SOP template: Validation of MS Excel
  • SOP template: Design and creation of MS Excel Spreadsheets including Best Practice Guide (Design)
  • MS Excel Validation Master Plan and Inventory List
  • MS Excel Templates – simple and complexe design – including Best Practice functions and add-ons
  • Validation Plan and Test templates
  • Optional: Online Tracking Tool / Password Repository
  • Optional: Training and 2 days implementation consultancy

By implementing this entire Focus Solution Package our customers can have compliant Spreadsheets in less than 20 days.

Contact us today at: talk@comes-compliance.com

ERP SAP ECC 6.0 meets ISPE GAMP 5 validation approach

At comes compliance services a new validation approach was designed for an efficient validation execution of the ERP SAP ECC 6.0. By integrating the SAP Best Practices for Healthcare including the building block methodology we can offer this special and pre-defined validation workflow to support the validation execution. Especially the ERP version upgrading process and data migration validation is covered by different tools and methods. We use the Best Practice approach together with the applicable release notes and migration analysis, e.g. customized code detection, data classification analysis, site impact analysis, and test plans for regression or automated testing.

This approach assures a full risk-based validation process according ISPE GAMP 5 in any ERP project.

Contact now our ERP validation experts at: talk@comes-compliance.com and ask us for more details of ERP SAP ECC 6.0 validation projects.