comes compliance services (CCS) is an independent, highly experienced, and premier consultancy service provider specializing in simplifying and streamlining EMA, FDA, ICH, ISPE GAMP 5 compliance & quality systems, and fulfilling validation and regulatory compliance requirements. CCS is managed by Markus Roemer.
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comes compliance services
Markus Roemer
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comes compliance services
Markus Roemer
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Rav●●●urg , 88214
DE
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https://comes-services.com
comes compliance services (CCS) is an independent, highly experienced, and premier consultancy service provider specializing in simplifying and streamlining EMA, FDA, ICH, ISPE GAMP 5 compliance & quality systems, and fulfilling validation and regulatory compliance requirements. CCS is managed by Markus Roemer.
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comes compliance services - imprint
http://www.comes-services.com/en/imprint-int
Policy Statement Effective Date: 1st October, 2009. Welcome to the internet site of comes compliance services ( www.comes-services.com. Please find contact details at the bottom of this page . PLEASE READ THESE TERMS AND CONDITIONS OF USE CAREFULLY BEFORE USING THIS WEBSITE. Use of Material from this Site. All trademarks, product names, company names or logos contained within this website are properties of their respective owners. Statement of Limited Liability. Your continued use of the website, tools, ...
comes compliance services - home
http://www.comes-services.com/en
When IT comes to compliance. Comes compliance services (CCS) is a consultancy service provider for the regulated industries. CCS provides professional services to clients of pharmaceutical manufacturing ( GMP. Medical devices, R&D and clinical studies, pharmacovigilance, eCTD, distribution, storage and logistics or similar areas. Our Compliance Proposals should fulfil your needs and your professional expectations - even at this early stage of a possible project work. We offer high quality, advanced consu...
comes compliance services - GxP Services
http://www.comes-services.com/ispe-gamp-5
ISPE GAMP 5 in der Praxis. Validierung kann Spass machen. Tools für die Validierung. Seite 1 von 6. ISPE GAMP 5 in der Praxis: IT Qualitätsmanagement für das 21. Jahrhundert.
comes compliance services - Home
http://www.comes-services.com/home
When IT comes to compliance. Die comes compliance services (CCS) ist ein Beratungsunternehmen für die regulierte Industrie. Wir führen Beratungsdienstleistungen bei unseren Klienten aus den Bereichen der pharmazeutischen Herstellung ( GMP. Dem Medizinproduktebereich, der Arzeimittelforschung und klinischen Studien, der Zulassung, der Pharmakovigilanz, der Distribution oder anderen verwandten Bereichen durch. Unsere Diensleistungen können in Form eines Festpreisangebots, als Rahmenvertrag oder nach tatsäc...
comes compliance services - News
http://www.comes-services.com/news-de
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Audit Service Center: Shared Third Party Audits by CCS – News
http://www.ccs-innovation.com/2015/04/audit-service-center-shared-third-party-audits-by-ccs
When IT comes to compliance…. Back to main page CCS. Audit Service Center: Shared Third Party Audits by CCS. 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. We develop a risk-based audit approach where quality audits represent an opp...
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...
FDA Guidance for Industry / Draft: Management of Cybersecurity in MEDDEV – News
http://www.ccs-innovation.com/2014/09/fda-guidance-for-industry-draft-management-of-cybersecurity-in-meddev
When IT comes to compliance…. Back to main page CCS. FDA Guidance for Industry / Draft: Management of Cybersecurity in MEDDEV. This guidance has been developed by the FDA to assist industry by identifying issues related. To cybersecurity that manufacturers should consider in preparing premarket submissions for. Read more: Guidance For Industry: Management of Cybersecurity. Contact us: talk@comes-services.com. FDA Guidance for Industry / Draft: Management of Cybersecurity in MEDDEV. Draft PIC/S Good Pract...
CCS links – News
http://www.ccs-innovation.com/category/ccs-links
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. As part of the new set of val...
Partners
http://www.renger-consulting.com/links/web-links
CCS is an independent and premier consulting company specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements. JD Technologies - Biopharmaceutical Technical Consulting and Services Jerry Dalfors (Network Partner). Inspection-Ready (IR) Quality Consulting. Inspection-Ready (IR) Quality Consulting - Mag. Gabriela Schallmeiner. Double Dragon Consulting - George Bernstein, Ph.D. Behrens Projektmanagement - Detlef Behrens.
Part 11 and Annex 11 – Commonality Analysis for the number 11 – News
http://www.ccs-innovation.com/2014/10/part-11-and-annex-11-commonality-analysis-for-the-number-11
When IT comes to compliance…. Back to main page CCS. Part 11 and Annex 11 – Commonality Analysis for the number 11. It seems that the number 11 is prereserved to computerized system topics in the GMP regulated industry. Beside of EU EudraLex Vol.4 Annex 11 and 21 CFR Part 11 the PIC/S guideline for computerized systems hold this number (PI 011) or the German Expert Inspector Group with EFG 11. The IT Infrastructure Qualification. The rules governing medicinal products in the European Union is structured ...
IT-Compliance im GMP Umfeld: BioLAGO-Experten mit neuen Publikationen – News
http://www.ccs-innovation.com/2015/05/it-compliance-im-gmp-umfeld-biolago-experten-mit-neuen-publikationen
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. IT-Compliance im GMP Umfeld: BioLAGO-Experten mit neuen Publikationen. GMP Datenintegrität – Schulung in der Schweiz – Mai 2015. 50 Years of EU Pharmaceutical Legislation – EudraBook →. The 10 most visited posts in last 30 days:. A new number: 8400! WHO Expert C...
FREE webinar: validation and testing on April 23, 2015 – News
http://www.ccs-innovation.com/2015/02/free-webinar-validation-and-testing-on-april-23-2015
When IT comes to compliance…. Back to main page CCS. FREE webinar: validation and testing on April 23, 2015. Join our free webinar – validation and testing – on April 23, 2015. Read more and register for free. Or contact us at: talk@comes-services.com. FREE webinar: validation and testing on April 23, 2015. CCS wird ISPE-DACH PREMIUM UNTERSTÜTZER. MHRA update – March 2015 – Good manufacturing practice: data integrity definitions →. The 10 most visited posts in last 30 days:. A new number: 8400! WHO Exper...
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How to validate Software Development tools used for GXP and MedDev? Join our Event on 27. November 2018 - Read More: Event. When IT comes to compliance. Die comes compliance services (CCS) ist ein Beratungsunternehmen für die regulierte Industrie. Wir führen Beratungsdienstleistungen bei unseren Klienten aus den Bereichen der pharmazeutischen Herstellung ( GMP. Mit einer interdisziplinären Komplementärberatung können wir sowohl auf Management-Ebene oder in den operativen Bereichen eingesetzt werden.
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