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

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

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

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 . . . → Read More: The Evolution of Electronic Document Management Systems by GxPi

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

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

CCS at Chemanager Buyers Guide and businesstoday

Find now comes compliance services in the buyers guide at chemanager – online:

http://www.chemanager-online.com/buyers-guide/comes-compliance-services

In addition, find our company profile (German) now at businesstoday:

http://www.business-2day.de/index.php?artikel=-CCS-&arid=5001848&pageid=420

. . . → Read More: CCS at Chemanager Buyers Guide and businesstoday

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 . . . → Read More: MS Excel Spreadsheet Validation – New Focused Solution Packages (FSP) by CCS

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 . . . → Read More: ERP SAP ECC 6.0 meets ISPE GAMP 5 validation approach

Audit Service Center Upgraded at www.auditservicecenter.com

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

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 . . . → Read More: Audit Service Center Upgraded at www.auditservicecenter.com

MS Sharepoint: GMP compliant document & quality management system

comes compliance services offers a new and GMP compliant Document and Quality Management System on the basis of MS Sharepoint. The product from the CCS Partner GxPi provides a well structured and unique document management platform including full audit trail, pre-defined document workflows, version and status control, electronic and digital signature technology, and additional compliance management modules. This . . . → Read More: MS Sharepoint: GMP compliant document & quality management system

CCS at FindPharma online

Find now comes compliance services at the FindPharma web portal: Open FindPharma

source link: http://suppliers.findpharma.com/ShowCase.aspx?sid=10116

Additionally comes compliance services  expanded their Qualified Person Support Services. We can now offer topnotch QP experts to the GMP regulated industry. Contact now talk@comes-compliance.com for . . . → Read More: CCS at FindPharma online