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German Translation Annex 11 – Deutsche Übersetzung Anhang 11 – Revision 2011

By comes compliance services, on Oktober 10th, 2011%

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

ISPE DACH Affiliate event: 21. / 22. November 2011

By comes compliance services, on August 24th, 2011%

Meet us at the ISPE DACH Affiliate Event (21. / 22. November 2011) in Biberach, . . . → Read More: ISPE DACH Affiliate event: 21. / 22. November 2011

“UNI meets Pharma 2011″ Event Sponsor

By comes compliance services, on August 17th, 2011%

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: . . . → Read More: “UNI meets Pharma 2011″ Event Sponsor

GMP Paperback Computer System Validation Revision 2011

By comes compliance services, on Juli 10th, 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 . . . → Read More: GMP Paperback Computer System Validation Revision 2011

Pharma 2.0 – PTS Training – 13.& 14. September 2011 in Wiesbaden, Germany

By comes compliance services, on Juni 14th, 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 . . . → Read More: Pharma 2.0 – PTS Training – 13.& 14. September 2011 in Wiesbaden, Germany

CCS at GMP and Technology Conference 2011

By comes compliance services, on Juni 11th, 2011%

Event details: 20. -21. October 2011 in Freiburg / Germany.

Download the conference brochure here.

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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 . . . → Read More: CCS at GMP and Technology Conference 2011

Annex 11 – “Computerised Systems” – Revision 2011 – Implementation

By comes compliance services, on Juni 11th, 2011%

Article published on Pharmaceutical Technology Europe – New Annex 11: Enabling Innovation -

Read it online . . . → Read More: Annex 11 – “Computerised Systems” – Revision 2011 – Implementation

CCS brochure – online

By comes compliance services, on April 13th, 2011%

Read the CCS brochure online:

Open publication – . . . → Read More: CCS brochure – online

The Evolution of Electronic Document Management Systems by GxPi

By comes compliance services, on März 9th, 2011%

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

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

By comes compliance services, on Januar 14th, 2011%

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 . . . → Read More: NEW ANNEX 11 – Computerised Systems – revision January 2011 – CCS solution package