Managing 21 CFR Part 11 Compliance

 Zorch Software provides comprehensive Microsoft-based document management and submission management solutions to help life science companies organize, manage and optimize their regulatory documents and regulatory submissions. Global pharmaceutical, biotechnology and medical device companies have engaged Zorch to improve their R&D project and resource management infrastructure and processes.  The Zorch management team has engaged in over 200 FDA regulated document control software validations.  In mid 2007 Zorch will release a new solution that introduces regulatory document management, metadata-driven eCTD submission assembly and submission lifecycle management all based on Microsoft Office SharePoint Server (MOSS 2007) platform.

The Collaborative Document Generation and Workflow solution is a comprehensive Document Creation application that automatically generates word documents for very complex documents with a high degree of business rules and processing.  Some of the processing includes:
• The ability to generate a document completely from business data.
• The ability to restrict which users have access to which parts of a document
• The ability to take documents “off-line”, edit them, and then to pull them back into the system to update business data.
• The ability to input data into the Word document and then have that data pulled back into the application and business database.

It also includes a comprehensive Workflow process that manages each users work through the system to review and approve documents and to perform sequential tasks throughout the system.

A quality process that lighten the need for companies to undertake significant internal review prior to submission in preparing and validating the SPL XML data.           

    The ability to keep labeling documents within Microsoft Share Point Electronic Document Management System, so it meets document compliance and record management requirements.                                                   

       SPLGen  has an option to import SPL compliant XML data files from other systems like DailyMed.

The Vorsite Connector provide integration points between Microsoft Office SharePoint Products and Technologies and enterprise content management systems such as Documentum and FileNet.

Key features include: content/document sharing, portal integration, unified  and federated search.

Workshare Professional is an Outbound Content Security and Document Integrity solution that eliminates the risk of content leaks and inaccuracies, enabling the safe, compliant and high speed information exchange needed in today’s competitive business environment.  Workshare Professional ensures the secure, accurate, and compliant production and exchange of your contracts, term sheets and other business critical documents. With Workshare you can exchange important documents and be certain the right information – and only the right information – is in your document.

Workshare, an information security company, delivers Secure Content Compliance solutions ensuring safe information exchange without business disruption. Workshare's solutions are used by over 5,500 organizations in 65 countries.

Millions of documents, emails and other electronic communications with private, confidential, or otherwise sensitive information leave organizations every day. Insider leakage of confidential info, whether inadvertent or malicious, demands action due to the financial, privacy and legal implications.    Protect Enterprise Suite alerts your users to potentially embarrassing, regulated or confidential content disclosures before they happen, cures risky content when appropriate, and blocks only when necessary - plugging leaks such as:  1) Confidential consumer or customer info violating global, Federal and state regulations, 2) Trade secrets, patents, customer lists, and other intellectual property, 3) Financial information prior to disclosure date, and 4) Server names and email addresses revealing a map to the corporate network leaving it exposed to outside-in network attacks.

K2.net 2007 (code named BlackPearl) is the next generation product based on the award winning K2.net 2003 enterprise workflow solution. K2.net 2003 launched with Office 2003 and K2.net 2007 will launch in the same timeframe as Office 2007. K2.net BlackPearl adds over 200 new features from the previous version and has been heralded as the leader of advanced workflow and enhanced business process management (BPM) solutions.

K2.net helps customers increase profitability, reduce costs, improve customer satisfaction, and maintain compliance efforts.