comes compliance services

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

The PDA event Parenterals 2010: Integrating Process, Technology and Regulation in Berlin is sponsored by CCS.

Event details: OPEN

More Information: OPEN

. . . → Read More: PDA Parenterals 2010: Integrating Process, Technology and Regulation sponsored by CCS

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

FDA has announced (08-July-2010) that “The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance).”

It has been about seven years that US-FDA . . . → Read More: US FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) – CCS assessment services

comes compliance services  initiates a new business partnership with cr.appliance – visit http://www.cr-appliance.com/.

The partnership aims to offer consultancy for companies in the healthcare industry in the development and registration of drugs in early clinical development, including support and planning for biopharmaceutical development projects, providing additional external expertise during the submission and licensing process, and on life cycle management . . . → Read More: New partnership with cr.appliance – closing gaps from pharma development to submission

Read in the July issue of  the magazin Pharmaceutical Technology Europe (PTE) about the CCS eValidation concepts and solutions – Product Showcase.

Digital version: http://pharmtech.findpharma.com/pharmtech/issue/issueDetail.jsp?id=19117

Pharmaceutical Technology Europe (PTE) reports on developments in European pharmaceutical/biopharmaceutical development, manufacturing, and quality assurance and control. Providing technically focused peer-reviewed editorial, opinion, trends and analysis, PTE assists readers in their decision-making and implementation of . . . → Read More: Pharmaceutical Technology Europe, Jul 1, 2010: CCS Product Showcase

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

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

Current Newsletters at BIOPRO:

Member CCS joined BioLago e.V. (EN)
Member CCS joinde BioLago e.V. (DE)
Ernst & Young: “German Biotechnology Report 2010″

Baden-Württemberg is the most innovative region in Europe. The figures for 2008 show that 4.2 percent of the gross domestic product is being invested in research and development. With its versatile, outstandingly efficient research in biotechnology and the . . . → Read More: News: BIOPRO Baden-Württemberg

CCS provides risk-based and compliant Validation and Qualification Services based on current regulations and standards. The German ZLG (central autority for helth protection) issed a new  Aide mémoire 07121105 “Inspektion von Qualifizierung und Validierung in pharmazeutischer Herstellung und Qualitätskontrolle”.

Read more here.

Contact CCS for more . . . → Read More: CCS News: German ZLG Aide mémoire 07121105 “Inspektion von Qualifizierung und Validierung in pharmazeutischer Herstellung und Qualitätskontrolle”