The STATISTICA Document Management System (SDMS) is a complete, highly scalable, database solution package for managing electronic documents.
The product enables you to quickly, efficiently, and securely manage documents of any type (e.g., find them, access them, search for content, review, organize, edit [with trail logging and versioning], approve, etc.).
It is specifically designed to ensure compliance with FDA 21 CFR Part 11 regulations, Sarbanes-Oxley legislation as well as ISO 9000, 9001, 14001 documentation requirements.
The key features include:
- Extremely transparent and easy to use
- Flexible, customizable (can be optionally configured for Web-enabled access) user interface
- Electronic Signatures
- Comprehensive Audit Trails, Approvals
- Optimized Searches
- Satisfy the FDA 21 CFR Part 11 Requirements
- Satisfy the Sarbanes-Oxley Legislation Requirements
- Satisfy ISO 9000 (9001, 14001) Documentation Requirements
- Unlimited scalability (from desktop or network Client-Server versions, to the ultimate size, Web-based worldwide systems)
- Open Architecture and Compatibility with Industry Standards
The STATISTICA Document Management System (SDMS) complies with the following:
The general requirements put forth in the Code of Federal Regulations (CFR) Title 21 Part 11 specify what a business needs to do in order to maintain electronic records acceptable for submission to the FDA (Food and Drug Administration).
Sarbanes-Oxley Legislation imposes new, extensive reporting and record keeping requirements on all publicly-traded companies and mandate that Executives of those companies take personal responsibility for the procedures of collecting data for the company's financial Reports and for the integrity of their contents. In order to comply with the requirements, companies need flexible software systems that facilitate record keeping and document management in a secure and efficient manner.
Guidelines for manufacturing in general (often collectively known as ISO 9000 standards) have been published by the International Organization for Standardization (e.g., see ISO 9001 4.5: Document and data control; also ISO 14001, Ch. 4.5.5.).
Integrates with all STATISTICA products
STATISTICA Document Management System (SDMS) seamlessly integrates with all STATISTICA products, from Base and Advanced to enterprise-wide installations such as STATISTICA Enterprise worldwide installations or STATISTICA Enterprise/QC for process analysis and quality control/improvement.
You can easily access all SDMS functionality from within your STATISTICA projects (e.g., all analysis projects, data mining, text mining, reporting, etc.). So directing your reports or data sets to the secure repository of SDMS is as easy as simply saving a file, because your authentication can be based on your initial log-in into STATISTICA. No entry of additional passwords is necessary.
You can also build the functionality of SDMS into your shortcuts, automated STATISTICA applications, and other custom systems to simplify your work and enhance productivity.
Stand-alone, highly compatible application
SDMS can be used as a stand-alone system. But since SDMS uses COM and SOAP-based architecture, and is compatible with the Microsoft WebService interface, it can also be called from other applications, integrated into existing systems, or expanded by adding custom functionality.
Compatibility with other standards
Please also inquire about the compatibility of STATISTICA Document Management System (SDMS) with the Open Document Management API (ODMA) standard, and the interfaces and support for the Web-based Distributed Authoring and Versioning (WebDAV) standard.
The STATISTICA Document Management System (SDMS) is available in an Enterprise Version, or in an Entry Level version (designed for smaller groups of users):
The Enterprise Version can be deployed in one of two ways, depending on whether the user needs to build the SDMS functionality into an existing database system:
SDMS can be configured as a stand-alone complete application driven by a high-performance general database engine based on Microsoft SQL Server.
SDMS can be integrated with an already existing database infrastructure or data warehouse. SDMS is compatible with industry standard database management systems such as Oracle, MS SQL Server, Sybase, Informix, and DB2.
The Entry Level Version is recommended for smaller installations (usually 5 to 10 simultaneous users, depending on the volume of their work). The Entry Level version does not include (or require) a high performance, scalable database engine, because it is based on a fixed database management component built into the product. This makes the Entry Level Version more cost effective, but it is still a fully functional, secure, and large capacity document management system. It can also be easily converted later, as your needs grow, into the fully scalable Enterprise Version described above.
How the STATISTICA Document Management System Works
To satisfy the diverse functionality and security requirements of various types of users, the STATISTICA Document Management System (SDMS) implements several options for managing documents:
- SDMS enables you to save documents to a secure repository database from within STATISTICA, WebSTATISTICA, or the stand-alone SDMS application. Its intuitive user interface allows you to easily perform all document management operations from any computer on your network, or even via the Internet.
- Most document types can be automatically maintained in both (a) the archival, non-editable "review-only" PDF format, with the appropriate electronic signatures, and (b) the editable "source" format that allows those with the appropriate access privileges to create new, modified versions of the document. None of the edits or changes, however, will ever overwrite the source file of the previous version--they will only add a new file to the repository.
- Strict security via electronic signatures (compliant with 21 CFR Part 11 and Sarbanes- Oxley Legislation requirements) is enforced. Different individuals or groups of users can be authorized to create, edit, or review documents in different parts of the archive.
- Documents in the archive cannot be deleted by end-users. Every time a document is edited, a new version is created and logged. The log will contain annotations to identify the time and the author of the modifications. SDMS can be configured to include other information in the log as well.
- The program is configured so that no information is ever discarded. Previous document versions, document histories, logs, etc. are all preserved.
- Documents can be locked to prohibit any further editing.
- Approval trail requirements can be established, so that documents must be reviewed, approved, and signed (via electronic signatures) by designated supervisors before they can be placed in designated parts of the repository.
- A complete audit trail of all document changes is automatically created. The audit trail can be printed, or saved in electronic form, and then submitted to regulatory bodies or agencies.
- To satisfy formatting requirements for electronic submission of records, various options are available for maintaining renditions in PDF and XPORT file formats (see FDA "Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations").
Ensuring Security and Compliance
The STATISTICA Document Management System (SDMS) is not only a flexible, high-performance system that will increase your productivity by facilitating the management of crucial documents. SDMS also ensures compliance with the requirements of regulatory agencies, such as FDA 21 CFR Part 11, Sarbanes-Oxley Legislation, and ISO 9000.
Security, Electronic Signatures
- The STATISTICA Document Management System requires that passwords contain more than 6 letters and not to be of a "common" type, e.g., "111111" is not allowed.
- Passwords can be configured by the administrator to expire, so that users are forced to change passwords at regularly scheduled intervals.
- The system applies automatic user-lockout and maintains records for the administrators when a certain number of attempts were made to log into the system with the wrong password.
- The STATISTICA Document Management System allows you to define users, and groups of users, with appropriate privilege. Types of privileges include the permission to create documents, edit documents, review documents, approve documents, and so on.
Version Control and Audit Trails
- In the STATISTICA Document Management System, everything is documented and traceable. For example, documents are never deleted. When a document is edited, then a new version of that document is created, properly authenticated, and annotated with electronic signatures. Authorized and authenticated users can be required to explicitly check out the respective documents from the repository, and check the new versions into the repository with notes and documentation regarding the nature and purpose of the edits.
- When a document is checked in, the program can be configured to perform various verification and documentation operations. For example, it may require the user to complete a check-list stating the purpose of the edits, or a brief summary of the edits. The system is fully customizable during installation, so that annotations, signatures, or other requirements associated with the creation or editing of documents can be enforced.
- Summarization options allow authorized users to review the complete audit trail for requested documents.
- To help ensure compliance with regulatory requirements, different version of documents will persist indefinitely and cannot be deleted by end users.
- Options are available to perform simple or complex searches of the documents, and their various versions.
Recommended (and FDA Approved) Archival Document types
One of unique strengths of the STATISTICA Document Management System is its ability to store and exchange information in almost any electronic file format, including your proprietary formats. This allows you to share information internally in the ways that are most convenient for your organization. It also makes it possible to share documents externally by using practically all industry standard formats and protocols.
In particular, SDMS allows you to save data and reports as PDF files or XPORT files. These formats are the preferred file formats that are recommended in the FDA "Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations."
Like the entire STATISTICA system, the STATISTICA Document Management System is highly configurable, and its functionality is very compatible with other applications. So the system can be customized to accommodate your specific tasks, and can be integrated seamlessly into existing systems for data and document management.