comes compliance services

Shared Audit Setup with QPShare

admin — Mon, 23 Jan 2012 11:04:21 +0000

Our latest recommendation: How to find and setup a shared audit with other companies and QPs?

At our CCS Audit Service Center we do reference to the “QPSHARE” database, which is provided to the members of the European QP Association (external link). The European QP Association initiated a database comprising shared audits information between Qualified Persons.

In a first step QP Association members were asked to submit data about their suppliers using standardised Excel sheets, including name, country, address as well as the relevant products (APIs and excipients). These data were used to identify those suppliers more than one QP were interested in and to inform the QPs who named the supplier in question. Based on this information the QPs had the option to set up a joint audit of the supplier, e. g. by one of the QPs or by a third party, and to share the information. The approach of this project is very similar to that of a pilot project that was initiated by different authorities (e. g. FDA, EMA, EDQM, TGA) to identify those companies more than one authority wants to inspect. As a consequence, one authority might conduct an inspection and share the results with other partners.

The QPSHARE database displays potential suppliers more than one QP is interested in. Members of the European QP Association are able to identify suppliers and the number of QPs interested in auditing the supplier. Confidentiality will be maintained as the names of the QPs will not be displayed. If a member would like to contact the QPs related to a certain supplier, a button allows the member to send an automatic message to the other QPs. Only if the QPs who receive the message are interested they may disclose their identity and contact the colleague. Read more about QPSHARE.

If a common shared audit is found the audit plan, execution and reporting might be managed and controlled by the independent Third Party of Audit Service Center at CCS.

CCS looks back on a successful 2011

admin — Sat, 24 Dec 2011 12:29:22 +0000

comes compliance services (CCS) in Ravensburg continued double digit growth in 2011 by serving best-practice compliance services and solutions to a wide range of GxP-regulated companies and suppliers. Achieving high levels of customer satisfaction and meeting the expectations & project requirements require that CCS continually monitor and improve compliance strategies and concepts. Key to our business success is the level of customer repeat business and satisfied new customer wins in 2011 – by providing projects On-Time and On-Budget by utilizing highly competent and skilled consultants.

Our CCS Project Examples – successfully executed and finished in 2011:

Implementation and Validation of Production Systems and SCADA
Implementation and Validaton of Electronic Batch Recording Systems
Qualification and Validation of Building Management Systems
Support and Execution of PQRs and compliance programs
Validation of ERP, DMS, LIMS, QMS IT-Systems from several vendors
Training executions (public and in-house) and speaking at several GMP events
Consultancy PQM Systems: Quality Risk Management implementation
Audit and Inspection Preparations and Support, Pre-Audits and Action Plans
Production Quality Coverage and Quality on the Shop Floor concepts
Execution of Quality Periodic Reviews and Reporting / Trending
Assessments of GMP and medical device compliance
Process and Cleaning Validation for different products
Third Party Audit execution and reporting
SOP Development, Training Management, and Reality Checks
Validation and Qualification of laboratory systems
PAI support and verification, corrective actions planning
Support of Audit Programs and Concepts
Implementation and Validation of electronic deviation and CAPA systems
Annex 11 compliance checks and reporting
Validation of electronic requirements and test tools / applications
Support and Execution of Quality Remediation Plans
Implementation and Qualification of hygienic zones concepts and methods
Implementation of ICH Q9 and ICH Q10 including training

CCS joins MESA.org as member

admin — Mon, 17 Oct 2011 20:38:58 +0000

comes compliance services joined the MESA International organisation: MESA (Manufacturing Enterprise Solutions Association) International is a global community of manufacturers, producers, industry leaders and solution providers who are focused on improving Operations Management capabilities through the effective application of technology solutions and best . . . → Read More: CCS joins MESA.org as member

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

admin — Mon, 10 Oct 2011 20:26:06 +0000

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)

bwcon 2011: CCS networking

admin — Wed, 24 Aug 2011 06:51:49 +0000

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.

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

admin — Wed, 24 Aug 2011 06:30:55 +0000

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

admin — Wed, 17 Aug 2011 08:53:24 +0000

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

admin — Sun, 10 Jul 2011 09:35:13 +0000

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

admin — Tue, 14 Jun 2011 09:19:39 +0000

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

admin — Sat, 11 Jun 2011 07:31:30 +0000

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 compliance services