Meet us at the ISPE DACH Affiliate Event (21. / 22. November 2011) in Biberach, Germany.
“UNI meets Pharma 2011” Event Sponsor
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:
- Web: BioLago e.V.
- Event Brochure 2011
When: Monday, 19. September 2011; 15.30 Uhr
Where: Universität Konstanz, Hörsaal R 513
Or contact us directly at: talk@comes-services.com
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.
Pharma 2.0 – PTS Training – 13.& 14. September 2011 in Wiesbaden, Germany
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)
CCS at GMP and Technology Conference 2011
Event details: 20. -21. October 2011 in Freiburg / Germany.
Download the conference brochure here.
Contact us at talk@comes-compliance.com for more details.
_________________________________________
Session 6. Neuerungen im GMP Umfeld / Autorenwissen – Live
Moderation: Anita Maas, Maas & Peither AG, Dr. Maria Brecht, PTS Training Service
- Computervalidierung, elektronische Dokumentation:
Annex 11 und Kapitel 4 EU-GMP-Leitfaden
Markus Roemer, ccs comes compliance services
Annex 11 – “Computerised Systems” – Revision 2011 – Implementation
Article published on Pharmaceutical Technology Europe – New Annex 11: Enabling Innovation –
Read it online here.
EU GMP Annex 11 in French language can be downloaded here. (thanks to Mr. Yves Samson)
Update (July 2013) on Aide Mémoire 07121202 der ZLG: Überwachung computergestützter Systeme (Annex 11 / Anhang 11)
CCS brochure – online
Read the CCS brochure online:
[issuu layout=http%3A%2F%2Fskin.issuu.com%2Fv%2Flight%2Flayout.xml showflipbtn=true documentid=110413143651-2bb1df0068824ebf952698d4152ed3b5 docname=ccs_company_brochure username=comescomplianceservices loadinginfotext=CCS%20company%20brochure showhtmllink=true width=1100 height=500 unit=px]
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
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