NextDocs

Court Square and NextDocs Partner to Deliver Document Solutions

NextDocs — Tue, 30 Oct 2007 22:05:00 GMT

Court Square Data Group and NextDocs Corp. are partnering to bring electronic document management solutions to biotech, pharmaceutical and medical device firms that must comply with stringent FDA regulations.

Wayne, PA and Springfield, Mass., October 30, 2007 – – Court Square Data Group, Inc., Springfield, Mass., and NextDocs Corp., Wayne, Pa., announced today that they are partnering to deliver document management solutions to biotech, pharmaceutical and medical device firms that must comply with Food & Drug Administration (FDA) regulations. Court Square will provide hosted-solutions and project management and integration services to NextDocs customers who use its 21 CFR Part 11 compliant document and quality management products.

Court Square was founded a dozen years ago to develop infrastructure and application management services to support companies in biotech, pharmaceutical, medical device and other regulated industries. Recently, the company unveiled a set of GSP-BIO IT services specifically designed to meet the needs of emerging growth firms that need cost-effective IT solutions to help them bring their drug products to market.

“Our goal is to make regulatory compliance an everyday part of the business,” said Court Square CEO Keith Parent. “So we developed a line of Good Systems Practice (GSP) services that incorporate IT Infrastructure Library (ITIL), Six Sigma and CobiT methodologies which are optimized for FDA environments. Court Square will install NextDocs software for customers, ensuring that the systems are validated and qualified to meet all FDA mandates. In addition, Court Square will offer the same document management product as a hosted solution for customers who lack the IT staff or expertise needed to manage it on their own.”

“NextDocs has developed a powerful family of document and quality management solutions that are specifically designed to meet the needs of biotech, pharmaceutical and other FDA-regulated firms,” said NextDocs CEO Zikria Syed. “We built this application atop the Microsoft SharePoint 2007 platform, ensuring compatibility with the most widely adopted business applications. In addition, we took full advantage of SharePoint’s ability to function as a web portal, enabling NextDocs customers to access and use our software throughout the distributed enterprise.”

About Court Square
Court Square Data Group, Inc., is a strategic consulting firm providing IT solutions for companies in transition. The company’s Good Systems Practice services are based on the most stringent quality service methodologies, and are optimized for government-regulated environments. Court Square has offices in Massachusetts, Connecticut, New Jersey and Indiana. The company serves pharmaceutical, biotechnology, medical device and manufacturing companies throughout the United States. For information visit www.csdg.com.

About NextDocs

NextDocs provides document and quality management software for life sciences companies. For more information please visit www.nextdocs.com.

Court Square Data Group, Good Systems Practice, and GSP are trademarks or registered trademarks of Court Square Data Group, Inc.

NextDocs and its products names are trademarks or registered trademarks of NextDocs Corp.

For more information please contact:

Zikria Syed, 484.846.1199, zsyed@nextdocs.com, www.nextdocs.com

NextDocs Connector for EXTEDO eCTDmanager Suite is released

NextDocs — Fri, 21 Sep 2007 21:42:00 GMT

NextDocs and EXTEDO Announce Strategic Partnership

NextDocs Connector for EXTEDO eCTDmanager Suite is released

Wayne, PA and Seattle, WA – June 15, 2007

NextDocs, a leading provider of regulatory document and quality management software today announced a strategic partnership with EXTEDO, a global leader in electronic regulatory submission management and document compliance. This partnership allows the companies to offer a combined solution for Document Management and Regulatory Submissions. The NextDocs Connector for EXTEDO eCTDmanager™ Suite provides out of the box integration between the two products thus providing a comprehensive and integrated solution.

“EXTEDO's eCTDmanager Compliance Suite is a comprehensive and easy-to-use Regulatory Submission Management system for the assembly of ICH eCTD compliant electronic dossiers.” said Zikria Syed, CEO, NextDocs, “Integrating it with NextDocs adds significant value to our offerings.”

“NextDocs Document Management is a leading edge, web-based document management solution. It extends the capabilities of Microsoft Office SharePoint Server to meet the regulatory and compliance requirements for 21 CFR Part 11.” said Lee Knoch, President and CEO, EXTEDO, “Customers are demanding open, extranet capable and easy-to-use solutions like NextDocs Document Management.”

About NextDocs

NextDocs provides Microsoft Office SharePoint Server based document, quality and compliance management software for life sciences companies. By taking advantage of the built-in functionality in SharePoint and adding the needed functionality for process, workflow, auditing, document portability, NextDocs provides leading edge and innovative solutions to meet the changing needs of Life Sciences companies.

Designed specifically for Life Sciences, NextDocs is fully 21 CFR Part 11 compliant and adds features to SharePoint necessary for common business process functions and regulatory compliance. All of this is accomplished in an Internet/extranet environment, to mirror the way companies collaborate and exchange content in today’s IT environment.

About Extedo

With offices in the United States, Germany and the UK, EXTEDO (IABG Life Sciences Solutions) is a global leader in electronic regulatory submission and document compliance solutions focused on the life cycle management and approval of pharmaceutical and crop protection products. With over a decade of experience, EXTEDO’s solutions support all current standards of paper based, hybrid and electronic submissions such as CTD, eCTD, CADDY, CADDY.XML and more. EXTEDO’s Agency eCTD review and validation solution, EURS is Yours™ has been chosen by EMEA for its National Competent Authorities.

NextDocs chosen by Microsoft as a 2007 Microsoft Office System Launch Partner

NextDocs — Mon, 05 Feb 2007 04:17:00 GMT

NextDocs has been collaborating with Microsoft on the development of the NextDocs Document Management System since last year when the 2007 Microsoft Office System product was in beta. This partnership has been key to enabling NextDocs to have their product suite released and available when the 2007 Microsoft Office System launched. NextDocs is proud to accept Microsoft's recognition as a 2007 Microsoft Office System Launch Partner!

NextDocs Presentation Overview

NextDocs — Thu, 04 Jan 2007 19:00:00 GMT

NextDocs is one of the first companies to deliver a Microsoft SharePoint 2007-based document management product with built-in support for digital signatures and advanced workflow to help comply with industry regulations such as FDA 21 CFR Part 11. Learn about the company by downloading the attached power point presentation.

Built on the Microsoft Office SharePoint 2007 platform, NextDocs Promotion Builder provides the ability and tools for regulatory compliance and operational excellence without sacrificing usability and affordability.

NextDocs — Thu, 04 Jan 2007 16:56:00 GMT

Built on the Microsoft Office SharePoint 2007 platform, NextDocs Promotion Builder provides the ability and tools for regulatory compliance and operational excellence without sacrificing usability and affordability. It provides the ability to track, approve and man-age data in a secure and centralized repository. NextDocs Promotion Builder solution is designed from the ground up to be:

Simple
Cost effective
Easy to deploy and use
Extranet capable
Paperless

Product Features:

Online annotation and markups.
Ability to automate processing and approval of data using built-in workflows through tasks and email reminders.
Approvals and signatures supported through the use of universal PKI based digital signatures.
Easy to use browser based application and zero desktop install.
Support for FDA 21 CFR Part 11.
Detailed audit logs and reports enable compliance.

Built on the Microsoft Office SharePoint 2007 platform, NextDocs Compliance Builder provides the ability and tools for regulatory compliance and operational excellence without sacrificing usability and affordability.

NextDocs — Thu, 04 Jan 2007 16:56:00 GMT

Built on the Microsoft Office SharePoint 2007 platform, NextDocs Compliance Builder provides the ability and tools for regulatory compliance and operational excellence without sacrificing usability and affordability. It provides the ability to track, approve and manage data in a secure and centralized repository. NextDocs Quality Com-pliance solution is designed from the ground up to be:

Simple
Cost effective
Easy to deploy and use
Extranet capable
Paperless

Product Features:

Ability to track data in tabular format including Microsoft Excel with complete version history and detailed audit trails at the cell level.
Ability to automate processing and approval of data using built-in workflows through tasks and email reminders.
Approvals and signatures supported through the use of universal PKI based digital signatures.
Extensive file compare capabilities providing detailed change tracking down to the cell and formula level in Microsoft Excel.
Easy to use browser based application and zero desktop install.
Support for FDA 21 CFR Part 11.
Built in workflows.
Detailed audit logs and reports enable compliance.

Built on the leading Microsoft Office Share-Point 2007 platform, NextDocs Quality Management provides the ability and tools for regulatory compliance and operational excellence without sacrificing usability and affordability.

NextDocs — Thu, 04 Jan 2007 16:54:00 GMT

Built on the leading Microsoft Office Share-Point 2007 platform, NextDocs Quality Management provides the ability and tools for regulatory compliance and operational excellence without sacrificing usability and affordability. NextDocs Quality Management solu-tion is designed from the ground up to be:

Simple
Cost effective
Easy to deploy and use
Extranet capable
Paperless

Product Features:

Enterprise wide process and SOP management.
Employee training, certifications and records management.
Audits and investigations.
Exceptions and deviations.
Correction Action / Preventive Action (CAPA).
Project control and documentation.
Built in workflows.
Support for 21 CFR Part 11 compliance.
Detailed audit logs and reports enable compliance.
Portal and dashboard.

NextDocs Document Management (DM) is an easy to use system with necessary support for compliance with 21 CFR Part 11.

NextDocs — Thu, 04 Jan 2007 16:52:00 GMT

NextDocs DM is an easy to use software solution that provides the necessary support for compliance with FDA 21 CFR Part 11. It includes versioning, check-in/check-out, auditing, security, workflow, reporting, retention policies and other advanced features to assist with managing electronic documents and records. Our Document Management product is designed to specifically address the following business needs:

Creation, collection, and management of documents
Appropriate security and access control
Quality control and compliance
Auditing and reporting
Document retention policies for records management

Product Features:

Document life cycle management provides consistency and control over document creation and management.
Versioning provides support major and minor versions with associated meta data.
Flexible security provides the ability to easily manage access to documents and all associated functions.
Templates allow easy access to common document types eliminating errors and redundant effort.
Automated workflows provide the ability to control document life cycle from creation to archival.
Universal digital signatures provide visible embedded signatures that protect the authenticity of documents and signatures. Word, PDF, Excel and other common file format are supported.
Support for 21 CFR Part 11 compliance is built into the product.

Visit NextDocs at the DIA Electronic Document Management (EDM) 20th Anniversary Conference

NextDocs — Thu, 04 Jan 2007 16:29:00 GMT

Visit NextDocs at the upcoming DIA Electronic Document Management (EDM) 20th Anniversary Conference February 6th – 9th, 2007 at Loews Hotel, Philadelphia, Pennsylvania.

More information about the event can be found here www.diahome.org/product/11363/07003.pdf

NextDocs partners with Microsoft to support 21 CFR Part 11 Compliance with Office 2007

NextDocs — Thu, 04 Jan 2007 05:41:00 GMT

NextDocs builds on the Office 2007 platform to provide the necessary functionality to support 21 CFR Part 11 compliance including workflow, audit trails, digital signatures, and full versioning support. http://www.microsoft.com/office/showcase/2007/cfr/partnersol.mspx