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 of organisations around the implementation of compliance related systems have evolved, which has significantly changed the relationship between the people, process and technology.

The tendency now in the experienced organisations (those where EDM is in its 2nd or 3rd generation) is to implement a configurable platform, providing a set of functionality to support the users but not to make the system wholly responsible but operate in conjunction with the working processes and the decisions made by the users themselves. This change can be loosely described as a rebalancing of the people-process-technology triangle, which is often used to describe the implementation of systems.

This evolution has resulted in advantages in terms of usability, acceptability and reduced total cost of ownership in ensuring GxP compliance. READ MORE

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23 March 2011 at 15:00 GMT

contact: atoepsch@gxpi.de

 

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 the new Annex 11 (Ref.: annex11_01-2011_en):

 This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.

The application should be validated; IT infrastructure should be qualified. 

Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process  control or quality assurance. There should be no increase in the overall risk of the process.

Contact now CCS for the new Annex 11 implementation package for efficient and compliant integration: talk@comes-compliance.com

  

CCS Network: News from GxPi – case studies/white papers

GxPi Ltd. is the UK partner of comes compliance services, providing excellent services and products to our customers. Find below current GxPi case studies and white papers: 

 Contact us today for more information or a product presentation: talk@comes-compliance.com

CCS continues steady growth in 2010 and 2011

comes compliance services  is looking back to a very successful year 2010. CCS successfully increased revenues as well as hired a number of new professionals to further strengthen the compliance management teams. A number of local and global compliance projects were successfully finished, e.g. FDA audit preparations, eValidation implementation, Quality Management integration, Corrective Action planning and management, FDA independent review tasks, IT system validation, MES, BMS, and SCADA projects. 

In 2011 several projects will be executed by CCS including HP Quality Center integration as eValidation tool, a full compliance tracking team on customer site, new ERP andMES validation projects, new quality plan integrations and corresponding remediation plans.

Three new team members will join CCS in January 2011, followed by several other experts and professionals for the regulated industry and more than 20 days of public trainings are already planned for several topics.

 when it comes to compliance….

www.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.

Pharmaceutical Technology Europe, Jul 1, 2010: CCS Product Showcase

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 best practice.

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.