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Back to main page CCS. Scroll down to content. MHRA’s GXP data integrity guide published – March 2018. After the British agency MHRA has published three (3) different draft versions of the – MHRA GMP Data Integrity Definitions and Guidance for Industry – in January and March 2015 (GMP) and in July 2016 (Draft for consultation – now for GXP) the final “Medicines and Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions. Was published in March 2018. 8211; data integrity...

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Back to main page CCS. Scroll down to content. MHRA’s GXP data integrity guide published – March 2018. After the British agency MHRA has published three (3) different draft versions of the – MHRA GMP Data Integrity Definitions and Guidance for Industry – in January and March 2015 (GMP) and in July 2016 (Draft for consultation – now for GXP) the final “Medicines and Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions. Was published in March 2018. 8211; data integrity...

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News | when IT comes to compliance… | ccs-innovation.com Reviews

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Back to main page CCS. Scroll down to content. MHRA’s GXP data integrity guide published – March 2018. After the British agency MHRA has published three (3) different draft versions of the – MHRA GMP Data Integrity Definitions and Guidance for Industry – in January and March 2015 (GMP) and in July 2016 (Draft for consultation – now for GXP) the final “Medicines and Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions. Was published in March 2018. 8211; data integrity...

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ccs-innovation.com

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The Purple Guide – Validation of electronic quality management systems (EQMS) – News

http://www.ccs-innovation.com/2015/04/the-purple-guide-validation-of-electronic-quality-management-systems-eqms

When IT comes to compliance…. Back to main page CCS. The Purple Guide – Validation of electronic quality management systems (EQMS). Written by a collective of experts in the Life Science industry this book discusses the best way to successfully implement and validate an EQMS within your organisation. The Purple Guide website is designed to be a useful resource for those taking the onward journey with articles and discussions from compliance. So order your book today and join the community. WHO Expert Com...

2

MHRA update – March 2015 – Good manufacturing practice: data integrity definitions – News

http://www.ccs-innovation.com/2015/03/mhra-update-march-2015-good-manufacturing-practice-data-integrity-definitions

When IT comes to compliance…. Back to main page CCS. MHRA update – March 2015 – Good manufacturing practice: data integrity definitions. The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated the revision 1.0 of January 2015 “good manufacturing practice data integrity expectations for the pharmaceutical industry” guidance document in March 2015. Find here revision 1.1 of the document (March 2015) for download: Good manufacturing practice: data integrity definitions. WHO Guideline Valid...

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GMP Datenintegrität – Schulung in der Schweiz – Mai 2015 – News

http://www.ccs-innovation.com/2015/05/gmp-datenintegritat-schulung-in-der-schweiz-mai-2015

When IT comes to compliance…. Back to main page CCS. GMP Datenintegrität – Schulung in der Schweiz – Mai 2015. Speziell zum Thema Datenintegrität and 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. Punkt 3 des Warning Letters:. In response to this letter, provide specific details about the comprehensive controls in place to ensure the integ...

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CCS events – News

http://www.ccs-innovation.com/category/ccs-events

When IT comes to compliance…. Back to main page CCS. CCS – 100 – business customers reached in 2016. Comes compliance services (CCS), a leading GXP consulting service provider, for Pharmaceutical Quality Systems, Data Governance and Integrity, Computer System Validation and Inspection Readiness Programs, today announced that it has acquired more than 100 business customers since the launch of its services in 2009. Pharmaceutical. EMA GMP Data Integrity Questions and Answers. Auf Einladung von BioLAGO hab...

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News – Page 2 – when IT comes to compliance…

http://www.ccs-innovation.com/page/2

When IT comes to compliance…. Back to main page CCS. US-FDA Guidance for Industry Data Integrity and Compliance (DRAFT). The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Part 210 covers 1Current Good Manufacturing Practice in Manufacturing, Processing,. FREE Webinar: Practical Introduction to Data Integrity in 30 minutes. Our business partner Montrium, Montreal, Canada, announced t...

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News | when IT comes to compliance…

Back to main page CCS. Scroll down to content. MHRA’s GXP data integrity guide published – March 2018. After the British agency MHRA has published three (3) different draft versions of the – MHRA GMP Data Integrity Definitions and Guidance for Industry – in January and March 2015 (GMP) and in July 2016 (Draft for consultation – now for GXP) the final “Medicines and Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions. Was published in March 2018. 8211; data integrity...

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News | when IT comes to compliance…

Back to main page CCS. IT-Compliance im GMP Umfeld: BioLAGO-Experten mit neuen Publikationen. LINK: Lesen Sie mehr hierzu bei BioLago e.V. Die CCS feiert dieses Jahr Ihre 5 jährige Mitgliedschaft bei der BioLago e.V. GMP Datenintegrität – Schulung in der Schweiz – Mai 2015. Audit Service Center: Shared Third Party Audits by CCS. CCS provides ready-to-use Validation Procedures, Templates and Forms. Each package includes additional integration and support services. Templates, forms and documents wi...The n...

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News | when IT comes to compliance…

Back to main page CCS. IT-Compliance im GMP Umfeld: BioLAGO-Experten mit neuen Publikationen. LINK: Lesen Sie mehr hierzu bei BioLago e.V. Die CCS feiert dieses Jahr Ihre 5 jährige Mitgliedschaft bei der BioLago e.V. GMP Datenintegrität – Schulung in der Schweiz – Mai 2015. Audit Service Center: Shared Third Party Audits by CCS. CCS provides ready-to-use Validation Procedures, Templates and Forms. Each package includes additional integration and support services. Templates, forms and documents wi...The n...

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