Standard Package FDA Compliant
Posted: 12/6/2006 1:46:22 PM
DocuWare 5 Meets Guidelines of U.S. Food and Drug Administration
The U.S. market is strictly regulated, to enforce legislation and protect American consumers. The Food and Drug Administration (FDA), for example, regulates the manufacturing, storing and sales of products in the pharmaceutical and food processing industries. Audits are regularly performed on companies working in these fields as well as any of their vendors/suppliers, and all are required to conduct strict tests accompanied by detailed documentation. This also includes any foreign companies supplying the U.S. market. Even IT systems used in this area must meet FDA regulations.
DocuWare submitted the newest version of its DocuWare integrated document management software under the FDA’s Title 21 Code of Federal Regulations (CFR) Part 11 for the Pharmaceutical and Food Processing Industries. This CFR outlines the requirements that software – and the processes they control – must meet.
DocuWare Processes meet Regulatory Compliance
The audit was conducted by META Solutions Inc., a consulting company specialized in the pharmaceutical and food processing industries. At DocuWare’s Germering/Germany headquarters, all of the company’s internal processes regarding software development, service and quality control in addition to the program’s functionality, were closely scrutinized. In particular, the high level of operational security provided by DocuWare and its support of all types of electronic signatures along with tamper-free archiving and detailed documentation of all processes satisfied the regulatory compliance required by the auditors.
At the end of the audit, the consultants prepared a White Paper demonstrating that DocuWare complies with all of the guidelines set forth in FDA - 21 CFR Part 11. The results of this audit are included in the DocuWare AG Regulatory Compliance Follow-up Audit Report“ prepared on December 11, 2006.
Document Management System for All Industries
By meeting FDA regulations, this integrated document management specialist has again demonstrated that its standard software package, DocuWare, can be used in companies of all sizes and industries. Even internationally pharmaceutical and food processing companies who are looking to automate and improve workflows for the long-term with document management, can find an ideal solution in DocuWare. It contains all of the components for powerful Enterprise Content Management yet remains easy to install, administer and use.
For more interesting articles on DocuWare go to : www.docuware.com/news
High-End Solutions for Mid-Sized Companies
Posted: 12/6/2006 2:15:15 PM
EMC Certifies DocuWare 5.1 for Centera Storage Systems
Germering, February 9, 2007 – EMC Centera Storage Systems can be seamlessly integrated in DocuWare 5.1. This was confirmed by the DMS specialist after EMC officially certified its latest version of DocuWare. Centera-based archiving solutions provide secure, long-term storage of very large quantities of data.
The certification of a software solution by other vendors of applications and products is often an important requirement for customers as they make their DMS choice. EMC enlisted AppLabs Technologies, an IT consulting company specialized in testing, to verify that Centera Storage Systems can be integrated in DocuWare 5.1 ENTERPRISE Server.
The newest DocuWare version successfully completed the test and qualified for the “EMC Centera Proven“ logo. This certificate proves that EMC Centera Storage Systems can be seamlessly integrated in DocuWare 5.1. It also means that secure, tamper-proof, long-term archiving directly out of DocuWare onto Centera Storage Systems is ensured - even for very large quantities of electronic information. Other advantages of Centera Systems are their scalability and reliability, characteristics they share with DocuWare 5.1 ENTERPRISE Server.
According to DocuWare President Jürgen Biffar: “Digital information is growing exponentially. Centera Storage Solutions - known for their high capacity, reliability and excellent security - are becoming increasingly popular within our core market of mid-sized organizations. EMC’s certification of our solution also proves again how easily DocuWare can be integrated.“
About EMC
EMC Corporation (NYSE: EMC) is the world¹s leading developer and provider of information infrastructure technology and solutions that enable organizations of all sizes to transform the way they compete and create value from their information. Information about EMC¹s products and services can be found at www.EMC.com.
For more interesting articles on DocuWare go to : www.docuware.com/news
Link to Scanners Made Easy
Posted: 12/27/2006 3:50:18 PM
ISIS Interface Integrated in DocuWare 5.1
Germering, February 14, 2007 – Version 5.1, the newest release of the DocuWare document management system, includes an interface to the EMC Captiva ISIS Driver as a standard feature. This provides a seamless, automatic link to most widely available scanners.
An important goal for DocuWare is to provide customers with broad and powerful functionality, even in its most basic software packages. To help users to effortlessly setup and work with scanners, DocuWare 5.1 supports TWAIN and now ISIS.
The ISIS interface is shipped as a standard feature with DocuWare 5.1, enabling the program to automatically connect to both entry-level devices as well as high-volume scanners.
Easy to use and install – two key characteristics of this DMS. By integrating ISIS scanner drivers, customers can reduce their adaptation effort and support costs.
For more interesting news releases about DocuWare go to : www.docuware.com/news
SAP Certifies DocuWare 5 for SAP NetWeaver
Posted: 12/27/2006 3:52:19 PM
Pure Connectivity
Germering, March 1st, 2007 – DocuWare 5 fulfills all the archiving requirements of the SAP ERP solution, which is why it was recently certified by SAP as ‘Interface Software for SAP NetWeaver ‘.
The DMS specialist has been one of SAP's software partners for many years. The first time the seamless integration of DocuWare's document management system with the SAP ERP solution was certified, was in 2001. SAP recently put DocuWare 5 and its module CONNECT to SAP under the microscope again. The most current software package of the DMS specialist passed a series of standardized tests to receive its SAP certification.
DocuWare CONNECT to SAP is an interface to DocuWare 5 based on the Microsoft.NET technology. It is designed to enhance SAP NetWeaver solutions with features to electronically file documents and data via the SAP ArchiveLink interface. For example, incoming/outgoing documents, print lists, SAP archive files as well as PC files (such as Microsoft Word or Excel files) can be directly stored out of SAP systems into a central document pool managed by DocuWare. With the integration, documents can be retrieved with a click of a button right out of the ERP solution - users never have to leave their familiar interface. Business processes speed up. DocuWare 5 offers the option to search, view and print documents outside the SAP system as well. The functionality of three components – HTTP Content Server, Barcode BAPI and OLE-Frontend – was certified.
DocuWare President, Jürgen Biffar, feels his company's strategy has been affirmed: “We base the development of our solutions on the newest technology, which definitely simplifies their integration within other applications. The certification of our product as ’Interface Software for SAP NetWeaver’ will help us build on our current success in the SAP market. With an extensive ERP system like SAP's, certification as an archiving solution is an important requirement for many customers making a DMS choice.“
For more interesting news releases about DocuWare go to : www.docuware.com/news
Manipulation - Impossible
Posted: 12/27/2006 3:54:07 PM
More Value through Integration
Germering, March 14, 2007 – With DocuWare 5.1 and the PoINT Jukebox Manager 5.0, users get another option for tamper-proof, long-term archiving of critical data. This combination provides several advantages to document management – such as central storage of different document types from a wide variety of sources – together with the high access speed of a hard disk and the security of a jukebox.
Retention schedules, controlled accessibility, data security and falsification prevention – all are important aspects for a long-term archiving of documents. Optical media provides a way to store large amounts of data in an unalterable format, which means they cannot be manipulated. Through the integration of PoINT Jukebox Manager 5.0 from PoINT Software & Systems GmbH within the DocuWare document management system, optical media can be directly addressed by the DMS. Automatic hard disk caching provides high performance since the documents are available for day-to-day access on a hard disk and then, written onto a CD/DVD for the purpose of long-term storage.
34 Terabytes in One Jukebox
Jukebox storage locations can now be accessed with the latest version, DocuWare 5.1. For example, a user can determine which magazine Jukebox and media types with the DMS should be used. DocuWare uses “logical disks“ for its storage management. When setting up a new logical disk in a certain location, the DMS automatically looks for a free media of the appropriate type within a selected magazine and then formats it. DocuWare 5.1 currently supports CD and DVD; in the second quarter of this year, support of Blu-ray Disks (BD) will be added. Up to 34 terabytes can be stored in one apparatus when the integrated solution is used with a Jukebox that was specially developed for BD, such as the DISC Series by DISC GmbH. The PoINT Jukebox Manager also uses a scalable hard disk cache for quick and easy access.
Thanks to optional mirroring, PoINT solution can also generate media with identical content in Jukebox systems in different locations. Mirroring guarantees 100 percent protection.
More Efficient Processes
By providing high speed and maximum security, DocuWare 5.1 and PoINT Jukebox Manager 5.0 help companies run their organizations more efficiently. Wasted time and costs are both significantly reduced. The additional security feature of both systems is an open architecture and is based on well-known industry standards.
For more interesting news releases about DocuWare go to :
www.docuware.com/news
