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 Excel Templates – simple and complexe design – including Best Practice functions and add-ons
  • Validation Plan and Test templates
  • Optional: Online Tracking Tool / Password Repository
  • Optional: Training and 2 days implementation consultancy

By implementing this entire Focus Solution Package our customers can have compliant Spreadsheets in less than 20 days.

Contact us today at: talk@comes-compliance.com

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 validation is covered by different tools and methods. We use the Best Practice approach together with the applicable release notes and migration analysis, e.g. customized code detection, data classification analysis, site impact analysis, and test plans for regression or automated testing.

This approach assures a full risk-based validation process according ISPE GAMP 5 in any ERP project.

Contact now our ERP validation experts at: talk@comes-compliance.com and ask us for more details of ERP SAP ECC 6.0 validation projects.

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 with the existing compliance programs of our clients we optimize such programs and manage quality audits of manufacturers of materials, products, components, and services providers, in GMP, GCP, GDP, GLP regulated industries such as pharmaceuticals, biologics, medical devices, cosmetics, dietary supplements.

Our team of highly dedicated quality experts delivers to our clients actionable strategic decision systems, improved supply chain processes and inspection readiness. The Audit Service Center implements tested and proven strategies, tools and methods to cut costs and increase profitability of  compliance and audit programs.

Our compliance projects ensure that supply chain requirements meet quality management support, be it for finding a second source of material or component supply, collaborating with suppliers on quality aspects, or investigating suitable outsourcing options. We create the “vendor to partner” dynamics required for improving products and reducing deficiencies.   

Visit now:  www.auditservicecenter.com to get more information and news about audit and CAPA management, supplier chain optimization, shared audits, and other compliance service options.

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 21 CFR Part 11 compliant system can be used for CAPA, OOS, deviation, investigation, and change control management. The MS look and feel makes the system easy to operate in a well known user interface.

Please contact us for more information or a  free web demo at: talk@comes-compliance.com

The one and only full GMP compliant DMS and QMS solution on MS Sharepoint.