�ݺ�ߣshows by User: NextDocs

�ݺ�ߣshows by User: NextDocs / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: NextDocs / Tue, 12 Apr 2011 13:45:21 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: NextDocs NextDocs Regulatory Document Management webinar 041211 /slideshow/nextdocs-regulatory-document-management-webinar-041211-["7604614"]/7604614 nextdocsregulatorydocumentmanagementwebinar041211-110412134523-phpapp02
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]]> Tue, 12 Apr 2011 13:45:21 GMT /slideshow/nextdocs-regulatory-document-management-webinar-041211-["7604614"]/7604614 NextDocs@slideshare.net(NextDocs) NextDocs Regulatory Document Management webinar 041211 NextDocs <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/nextdocsregulatorydocumentmanagementwebinar041211-110412134523-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" />

NextDocs Regulatory Document Management webinar 041211 from NextDocs

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1 NextDocs Regulatory Document Management webinar 041211 /slideshow/nextdocs-regulatory-document-management-webinar-041211-7604597/7604597 nextdocsregulatorydocumentmanagementwebinar041211-110412134342-phpapp01
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]]> Tue, 12 Apr 2011 13:43:37 GMT /slideshow/nextdocs-regulatory-document-management-webinar-041211-7604597/7604597 NextDocs@slideshare.net(NextDocs) NextDocs Regulatory Document Management webinar 041211 NextDocs <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/nextdocsregulatorydocumentmanagementwebinar041211-110412134342-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" />

NextDocs Regulatory Document Management webinar 041211 from NextDocs

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1 NextDocs Regulatory Document Management Webinar 041211 /NextDocs/nextdocs-regulatory-document-management-webinar-041211 nextdocsregulatorydocumentmanagementwebinar041211-110412134228-phpapp02
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]]> Tue, 12 Apr 2011 13:42:26 GMT /NextDocs/nextdocs-regulatory-document-management-webinar-041211 NextDocs@slideshare.net(NextDocs) NextDocs Regulatory Document Management Webinar 041211 NextDocs <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/nextdocsregulatorydocumentmanagementwebinar041211-110412134228-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" />

NextDocs Regulatory Document Management Webinar 041211 from NextDocs

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1 Quality Management System by NextDocs /slideshow/quality-management-system-by-nextdocs/7259924 qms-factsheet-110314103757-phpapp02
The NextDocs Qualty Management System consists of a variety of pre configured solutions for managing SOPs, deviations, complaints, audit findings, change control and CAPA to deliver compliant, user-friendly solutions while minimizing the demands on business and IT Users. For more information visit http://www.nextdocs.com]]>
The NextDocs Qualty Management System consists of a variety of pre configured solutions for managing SOPs, deviations, complaints, audit findings, change control and CAPA to deliver compliant, user-friendly solutions while minimizing the demands on business and IT Users. For more information visit http://www.nextdocs.com]]> Mon, 14 Mar 2011 10:37:53 GMT /slideshow/quality-management-system-by-nextdocs/7259924 NextDocs@slideshare.net(NextDocs) Quality Management System by NextDocs NextDocs The NextDocs Qualty Management System consists of a variety of pre configured solutions for managing SOPs, deviations, complaints, audit findings, change control and CAPA to deliver compliant, user-friendly solutions while minimizing the demands on business and IT Users. For more information visit http://www.nextdocs.com <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/qms-factsheet-110314103757-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> The NextDocs Qualty Management System consists of a variety of pre configured solutions for managing SOPs, deviations, complaints, audit findings, change control and CAPA to deliver compliant, user-friendly solutions while minimizing the demands on business and IT Users. For more information visit http://www.nextdocs.com

Quality Management System by NextDocs from NextDocs

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1 Sanofi Pasteur MSD Inoculates Itself Against Document Management Inefficiency - Case Study /slideshow/sanofi-pasteur-msd/7102867 sanofi-pasteur-msd-casestudy-110301092312-phpapp01
Overview Sanofi Pasteur MSD offers the widest range of vaccines of any company doing business in Europe today. It delivers vaccines to more than 390 million people in 19 countries, but before it can deliver those vaccines to those millions of people, Sanofi Pasteur MSD must collect and submit thousands of documents to as many as 19 separate regulatory agencies. The challenge for the company was the manual process of finding, capturing, reviewing, approving, and storing these documents. There was no consistent process for managing this task, no central document repository, and no significant automation. To overcome the inefficiencies and to enable process transparency, they began searching for a document management solution designed to meet the needs of Life Sciences companies. This solution needed to comply with recognized standards, had to be easy to use by employees in many locations, and had to fit in with the company’s IT strategy. The solution? The Document Management System from NextDocs.]]>
Overview Sanofi Pasteur MSD offers the widest range of vaccines of any company doing business in Europe today. It delivers vaccines to more than 390 million people in 19 countries, but before it can deliver those vaccines to those millions of people, Sanofi Pasteur MSD must collect and submit thousands of documents to as many as 19 separate regulatory agencies. The challenge for the company was the manual process of finding, capturing, reviewing, approving, and storing these documents. There was no consistent process for managing this task, no central document repository, and no significant automation. To overcome the inefficiencies and to enable process transparency, they began searching for a document management solution designed to meet the needs of Life Sciences companies. This solution needed to comply with recognized standards, had to be easy to use by employees in many locations, and had to fit in with the company’s IT strategy. The solution? The Document Management System from NextDocs.]]> Tue, 01 Mar 2011 09:23:08 GMT /slideshow/sanofi-pasteur-msd/7102867 NextDocs@slideshare.net(NextDocs) Sanofi Pasteur MSD Inoculates Itself Against Document Management Inefficiency - Case Study NextDocs Overview Sanofi Pasteur MSD offers the widest range of vaccines of any company doing business in Europe today. It delivers vaccines to more than 390 million people in 19 countries, but before it can deliver those vaccines to those millions of people, Sanofi Pasteur MSD must collect and submit thousands of documents to as many as 19 separate regulatory agencies. The challenge for the company was the manual process of finding, capturing, reviewing, approving, and storing these documents. There was no consistent process for managing this task, no central document repository, and no significant automation. To overcome the inefficiencies and to enable process transparency, they began searching for a document management solution designed to meet the needs of Life Sciences companies. This solution needed to comply with recognized standards, had to be easy to use by employees in many locations, and had to fit in with the company’s IT strategy. The solution? The Document Management System from NextDocs. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/sanofi-pasteur-msd-casestudy-110301092312-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Overview Sanofi Pasteur MSD offers the widest range of vaccines of any company doing business in Europe today. It delivers vaccines to more than 390 million people in 19 countries, but before it can deliver those vaccines to those millions of people, Sanofi Pasteur MSD must collect and submit thousands of documents to as many as 19 separate regulatory agencies. The challenge for the company was the manual process of finding, capturing, reviewing, approving, and storing these documents. There was no consistent process for managing this task, no central document repository, and no significant automation. To overcome the inefficiencies and to enable process transparency, they began searching for a document management solution designed to meet the needs of Life Sciences companies. This solution needed to comply with recognized standards, had to be easy to use by employees in many locations, and had to fit in with the company’s IT strategy. The solution? The Document Management System from NextDocs.

Sanofi Pasteur MSD Inoculates Itself Against Document Management Inefficiency - Case Study from NextDocs

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1 SOP Management Factsheet /slideshow/sop-management-factsheet/7102683 sop-factsheet-110301091236-phpapp02
“Failure to follow established SOPs is one of the most frequently cited violations in FDA 483s and warning letters. The frequency of SOP-related violations points to the need for all regulated companies to review their SOPs, their methods for distributing compliant SOP training curricula, their methods of validating receipt and testing for comprehension of the materials, and their documentation of SOP training activities. Additionally, enterprise-wide training programs must include automated methods for new employee on boarding, and for annual refresher training. “ BioPharm International Global Quality Assurance and Regulatory Compliance by Denise Queffelec and David Peterson The NextDocs' pre configured solution for managing procedural documentation addresses these key challenges to deliver a compliant, user-friendly solution while minimizing the demands on your already overtaxed business and IT users.]]>
“Failure to follow established SOPs is one of the most frequently cited violations in FDA 483s and warning letters. The frequency of SOP-related violations points to the need for all regulated companies to review their SOPs, their methods for distributing compliant SOP training curricula, their methods of validating receipt and testing for comprehension of the materials, and their documentation of SOP training activities. Additionally, enterprise-wide training programs must include automated methods for new employee on boarding, and for annual refresher training. “ BioPharm International Global Quality Assurance and Regulatory Compliance by Denise Queffelec and David Peterson The NextDocs' pre configured solution for managing procedural documentation addresses these key challenges to deliver a compliant, user-friendly solution while minimizing the demands on your already overtaxed business and IT users.]]> Tue, 01 Mar 2011 09:12:29 GMT /slideshow/sop-management-factsheet/7102683 NextDocs@slideshare.net(NextDocs) SOP Management Factsheet NextDocs “Failure to follow established SOPs is one of the most frequently cited violations in FDA 483s and warning letters. The frequency of SOP-related violations points to the need for all regulated companies to review their SOPs, their methods for distributing compliant SOP training curricula, their methods of validating receipt and testing for comprehension of the materials, and their documentation of SOP training activities. Additionally, enterprise-wide training programs must include automated methods for new employee on boarding, and for annual refresher training. “ BioPharm International Global Quality Assurance and Regulatory Compliance by Denise Queffelec and David Peterson The NextDocs' pre configured solution for managing procedural documentation addresses these key challenges to deliver a compliant, user-friendly solution while minimizing the demands on your already overtaxed business and IT users. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/sop-factsheet-110301091236-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> “Failure to follow established SOPs is one of the most frequently cited violations in FDA 483s and warning letters. The frequency of SOP-related violations points to the need for all regulated companies to review their SOPs, their methods for distributing compliant SOP training curricula, their methods of validating receipt and testing for comprehension of the materials, and their documentation of SOP training activities. Additionally, enterprise-wide training programs must include automated methods for new employee on boarding, and for annual refresher training. “ BioPharm International Global Quality Assurance and Regulatory Compliance by Denise Queffelec and David Peterson The NextDocs' pre configured solution for managing procedural documentation addresses these key challenges to deliver a compliant, user-friendly solution while minimizing the demands on your already overtaxed business and IT users.

SOP Management Factsheet from NextDocs

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1 Clinical Document Management Factsheet /slideshow/clinical-factsheet/7102386 clinical-factsheet-110301085026-phpapp02
NextDocs’ collaborative solution for clinical trials, built on Microsoft SharePoint provides an integrated platform that streamlines processes, automates information exchange, and dramatically reduces administrative overhead associated with running clinical trials. Our clinical portal allows clinical teams to work together in an effective and efficient manner by keeping trial personnel connected, informed and on task – providing access to everyone at any time, from anywhere. NextDocs Clinical Document Management solution is based on the NextDocs compliance platform, which includes a comprehensive set of features that address all ICH, FDA, EMEA, and MHLW regulatory requirements.]]>
NextDocs’ collaborative solution for clinical trials, built on Microsoft SharePoint provides an integrated platform that streamlines processes, automates information exchange, and dramatically reduces administrative overhead associated with running clinical trials. Our clinical portal allows clinical teams to work together in an effective and efficient manner by keeping trial personnel connected, informed and on task – providing access to everyone at any time, from anywhere. NextDocs Clinical Document Management solution is based on the NextDocs compliance platform, which includes a comprehensive set of features that address all ICH, FDA, EMEA, and MHLW regulatory requirements.]]> Tue, 01 Mar 2011 08:50:22 GMT /slideshow/clinical-factsheet/7102386 NextDocs@slideshare.net(NextDocs) Clinical Document Management Factsheet NextDocs NextDocs’ collaborative solution for clinical trials, built on Microsoft SharePoint provides an integrated platform that streamlines processes, automates information exchange, and dramatically reduces administrative overhead associated with running clinical trials. Our clinical portal allows clinical teams to work together in an effective and efficient manner by keeping trial personnel connected, informed and on task – providing access to everyone at any time, from anywhere. NextDocs Clinical Document Management solution is based on the NextDocs compliance platform, which includes a comprehensive set of features that address all ICH, FDA, EMEA, and MHLW regulatory requirements. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/clinical-factsheet-110301085026-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> NextDocs’ collaborative solution for clinical trials, built on Microsoft SharePoint provides an integrated platform that streamlines processes, automates information exchange, and dramatically reduces administrative overhead associated with running clinical trials. Our clinical portal allows clinical teams to work together in an effective and efficient manner by keeping trial personnel connected, informed and on task – providing access to everyone at any time, from anywhere. NextDocs Clinical Document Management solution is based on the NextDocs compliance platform, which includes a comprehensive set of features that address all ICH, FDA, EMEA, and MHLW regulatory requirements.

Clinical Document Management Factsheet from NextDocs

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1 21 CFR Part 11 Challenges and Solutions - White Paper /slideshow/white-paper-21cfr11/7048173 whitepaper-21cfr11-110224142158-phpapp01
Many sponsors are concerned with the risks and costs involved in ensuring that their electronic systems comply with the FDA’s ruling on acceptance of Electronic Records and Electronic Signatures in place of their paper equivalents (21 CFR Part 11). Although the ruling has been in place since 1997, there is often a lack of clarity concerning what characteristics and features a software solution must have to comply with 21 CFR Part 11. Even when a solution meets all of its requirements, ensuring that procedural requirements are met may be a bigger challenge. Although sponsors’ concerns are certainly valid, Part 11 compliance also provides an opportunity. Sponsors and the FDA share a common goal of ensuring the integrity of their data, documentation and computer systems. If Part 11 compliance can be achieved by software configured to represent the sponsor’s desired business process, the burden on both system users and IT administrators can be minimal. The sponsor can then achieve benefits around both process automation and process transparency. The intent of this paper is to describe how NextDocs products provide a built-in platform for 21 CFR Part 11 compliance while providing capabilities that allow sponsors to automate, monitor and control their processes.]]>
Many sponsors are concerned with the risks and costs involved in ensuring that their electronic systems comply with the FDA’s ruling on acceptance of Electronic Records and Electronic Signatures in place of their paper equivalents (21 CFR Part 11). Although the ruling has been in place since 1997, there is often a lack of clarity concerning what characteristics and features a software solution must have to comply with 21 CFR Part 11. Even when a solution meets all of its requirements, ensuring that procedural requirements are met may be a bigger challenge. Although sponsors’ concerns are certainly valid, Part 11 compliance also provides an opportunity. Sponsors and the FDA share a common goal of ensuring the integrity of their data, documentation and computer systems. If Part 11 compliance can be achieved by software configured to represent the sponsor’s desired business process, the burden on both system users and IT administrators can be minimal. The sponsor can then achieve benefits around both process automation and process transparency. The intent of this paper is to describe how NextDocs products provide a built-in platform for 21 CFR Part 11 compliance while providing capabilities that allow sponsors to automate, monitor and control their processes.]]> Thu, 24 Feb 2011 14:21:53 GMT /slideshow/white-paper-21cfr11/7048173 NextDocs@slideshare.net(NextDocs) 21 CFR Part 11 Challenges and Solutions - White Paper NextDocs Many sponsors are concerned with the risks and costs involved in ensuring that their electronic systems comply with the FDA’s ruling on acceptance of Electronic Records and Electronic Signatures in place of their paper equivalents (21 CFR Part 11). Although the ruling has been in place since 1997, there is often a lack of clarity concerning what characteristics and features a software solution must have to comply with 21 CFR Part 11. Even when a solution meets all of its requirements, ensuring that procedural requirements are met may be a bigger challenge. Although sponsors’ concerns are certainly valid, Part 11 compliance also provides an opportunity. Sponsors and the FDA share a common goal of ensuring the integrity of their data, documentation and computer systems. If Part 11 compliance can be achieved by software configured to represent the sponsor’s desired business process, the burden on both system users and IT administrators can be minimal. The sponsor can then achieve benefits around both process automation and process transparency. The intent of this paper is to describe how NextDocs products provide a built-in platform for 21 CFR Part 11 compliance while providing capabilities that allow sponsors to automate, monitor and control their processes. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/whitepaper-21cfr11-110224142158-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Many sponsors are concerned with the risks and costs involved in ensuring that their electronic systems comply with the FDA’s ruling on acceptance of Electronic Records and Electronic Signatures in place of their paper equivalents (21 CFR Part 11). Although the ruling has been in place since 1997, there is often a lack of clarity concerning what characteristics and features a software solution must have to comply with 21 CFR Part 11. Even when a solution meets all of its requirements, ensuring that procedural requirements are met may be a bigger challenge. Although sponsors’ concerns are certainly valid, Part 11 compliance also provides an opportunity. Sponsors and the FDA share a common goal of ensuring the integrity of their data, documentation and computer systems. If Part 11 compliance can be achieved by software configured to represent the sponsor’s desired business process, the burden on both system users and IT administrators can be minimal. The sponsor can then achieve benefits around both process automation and process transparency. The intent of this paper is to describe how NextDocs products provide a built-in platform for 21 CFR Part 11 compliance while providing capabilities that allow sponsors to automate, monitor and control their processes.

21 CFR Part 11 Challenges and Solutions - White Paper from NextDocs

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1 https://public.slidesharecdn.com/v2/images/profile-picture.png NextDocs is the global leader in providing Microsoft SharePoint-based document and quality management solutions to life sciences organizations. It enables businesses in regulated industries to achieve compliance with FDA and other agencies while automating processes, improving efficiency and dramatically reducing costs. NextDocs customers include Pharmaceutical companies, Bio-Techs, Medical Device companies and CROs. For more Information visit http://www.nextdocs.com www.nextdocs.com https://cdn.slidesharecdn.com/ss_thumbnails/nextdocsregulatorydocumentmanagementwebinar041211-110412134523-phpapp02-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/nextdocs-regulatory-document-management-webinar-041211-["7604614"]/7604614 NextDocs Regulatory Do... https://cdn.slidesharecdn.com/ss_thumbnails/nextdocsregulatorydocumentmanagementwebinar041211-110412134342-phpapp01-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/nextdocs-regulatory-document-management-webinar-041211-7604597/7604597 NextDocs Regulatory Do... https://cdn.slidesharecdn.com/ss_thumbnails/nextdocsregulatorydocumentmanagementwebinar041211-110412134228-phpapp02-thumbnail.jpg?width=320&height=320&fit=bounds NextDocs/nextdocs-regulatory-document-management-webinar-041211 NextDocs Regulatory Do...