GMP Datenintegrität – Schulung in der Schweiz – Mai 2015

Speziell zum Thema Datenintegrität & Rohdatenmanagement wird am 12.05.2015 in Olten – CH eine 1-Tages Schulung stattfinden. Obwohl viele Systeme im Labor als validiert gelten, sind diese heutig im Inspektionsfokus nicht mehr als valide zu verteidigen. Exemplarisch soll Bezug genommen werden auf

Audit Service Center: Shared Third Party Audits 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

Validation Templates

CCS provides ready-to-use Validation Procedures, Templates and Forms. Each package includes additional integration and support services. Templates, forms and documents will be provided in MS Word / MS Excel format, as download versions or during integration workshops on site. You

Annex 15: Qualification and Validation – Revision 2015

The new EudraLex  Annex 15 describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products. Deadline for coming into operation: 1 October 2015 Download Annex 15


Die comes compliance services (CCS) unterstützt als Premiumsponsor die ISPE Deutschland/Österreich/Schweiz. Besuchen Sie die ISPE DACH Webseite, informieren Sie sich über Expertengruppen, Veranstaltungen, Downloads oder werden Sie Miglied bei der ISPE DACH. Externer Link: ISPE DACH  

MHRA guidance sets for data integrity in GMP

The MHRA guidance set contains examples, expectations and definitions on GMP data integrity for the GMP regulated industry and was published on 23rd January 2015 . It complements existing EU GMP guidance and should be read in conjunction with national medicines legislation