Overview
The STATISTICA Document Management System 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 CFR 21
Part 11 regulations, as well as ISO 9000, 9001, 14001 documentation
requirements.
The key features include:
- Extremely transparent and easy to use
- Flexible, customizable (optionally Browser/Web-enabled) user
interface
- Electronic Signatures
- Comprehensive Auditing Trails, Approvals
- Optimized Searches
- Document Comparison Tools
- Security
- Satisfy the FDA CFR 21 Part 11 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
Compliance
FDA. 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).
ISO. Similar 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.).
Compatibility
Integrates with all STATISTICA products. STATISTICA
Document Management System seamlessly integrates with all STATISTICA
products, from desktop and network versions, to enterprise-wide
installations such as WebSTATISTICA-based worldwide
installations or SEWSS (for process analysis and quality
control/improvement). You can easily access all its functionality
from within your STATISTICA projects (e.g., all analysis
projects, data mining, text mining, reporting, etc.) where directing
your reports or data sets to the secure repository of the STATISTICA
Document Management System is as easy as simply saving a file
because your authentication can be based on your initial log-in into
the system, so no entry of additional passwords is necessary. You
can also build the functionality of the STATISTICA Document
Management System into your shortcuts, automated STATISTICA
applications, and other custom systems designed to simplify your
work and enhance productivity.
Stand-alone, highly compatible application. It can also be
used as a stand-alone system, or (thanks to its COM and SOAP-based
architecture) 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
with the Open Document Management API (ODMA) standard, and
the interfaces and support for the Web-based Distributed
Authoring and Versioning (WebDAV) standard.
Two versions
An Enterprise Version and an Entry Level version
(designed for smaller groups of users) of STATISTICA Document
Management System are available.
- The Enterprise Version can be deployed in one of
two ways depending on whether the user needs to build the
respective functionality into an existing database system:
Either (a) as a stand-alone complete application (optionally as
part of STATISTICA Data Warehouse)
driven by a high-performance general database engine (based on
Microsoft SQL Server), or - (b) in case integration with an
already existing database infrastructure or data warehouse is
preferred by the customer - as a database schema (effectively a
virtual database) compatible with most industry standard
database management systems (such as Oracle, MS SQL Server,
Sybase, Informix, or DB2), any easily deployed as part of your
existing infrastructure. STATISTICA Document Management
System will always seamlessly integrate into your existing
database or data warehouse infrastructure and your security
management system.
- A smaller version (STATISTICA Document Management
System, Entry Level) recommended for smaller
installations (usually with 5 to 10 simultaneous users,
depending on the volume of their work), is also available. 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, and
therefore, it is more cost effective when the volume of your
work does not require installation of a large scale database
system. It is still a fully functional, secure, and large
capacity document management system, however. Also, it can be
easily converted later - as your needs grow - into the fully
scalable Enterprise Version (see above), preserving all
its previous contents, indexes, users' access privileges, etc.
Overview and General Features:
How the STATISTICA Document Management System Works
To satisfy the diverse functionality and security requirements
of various types of users, STATISTICA Document Management System
implements a set of options to manage documents in a flexible and
secure database.
- STATISTICA Document Management System enables you to
save documents (from within STATISTICA, WebSTATISTICA,
or its stand alone console) to a secure repository database. Its
self-explanatory user interface allows you to easily perform all
document management operations (from any computer connected to
the network or (optionally) via the Internet).
- Most document types can be automatically maintained both in
(a) the archival, review-only (non-editable) PDF format,
featuring the appropriate electronic signatures, and also (b) in
the respective editable ("source") format allowing the
user with the appropriate access privileges to create new,
modified versions. None of the edits or changes, however, will
ever overwrite either the archival review-only, or the source
files of the previous version - they will only add a new pair of
files to the repository.
- Strict security via electronic signatures (compliant with CFR
21 Part 11 requirements) is enforced, and different groups of
users can be authorized to create, edit, or review documents in
different parts of the archive.
- Documents in the document archive cannot be deleted by
end-users, other than using a designated process accessible only
to the administrator with the top level access privileges. Every
time a document is edited, a new version is created and logged
with annotations (meta data) to identify the time and the author
of the modifications, and other information (either optional or
required by the local configuration).
- Various options are available to control how far back in time
a complete history of versions of documents is maintained (e.g.,
you may want to archive versions of documents that are older
than 10 years); the program can also be configured so that no
information (versions of documents) is ever discarded.
- Documents (e.g., containing results from analyses) can be
locked, to prohibit any further editing or creation of new
versions.
- 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 auditing trail of all document edits is
automatically created, and can be printed or saved in electronic
form, for submission to regulatory bodies or agencies.
- Backup of the specific segments of the repository (e.g., all
documents not older than 7 days) can be performed.
- To satisfy formatting requirements for electronic submission
of records, various options are available for generating reports
in PDF and XPORT file formats (see FDA "Guidance for
Industry: Providing Regulatory Submissions in Electronic Format
- General Considerations")
Ensuring Security and Compliance
STATISTICA Document Management System is designed to
deliver not only a flexible, high-performance system to manage your
documents in a way that will increase your productivity by
facilitating access to and management of crucial information, but
also to ensure security and compliance with the requirements of
regulatory agencies (e.g., FDA CFR 21 Part 11, ISO 9000).
Security, Electronic Signatures
- The STATISTICA Document Management System requires
valid passwords to 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 e-mail
notification of the administrator(s) when a certain number of
attempts is made to log into the system with the wrong password.
- STATISTICA Document Management System offers groupware
functionality, supports workgroups, and allows you to define
users and groups of users with specific privileges, such as the
permission to create documents, edit documents, review
documents, approve documents, and so on.
Version Control and Audit Trails
- In STATISTICA Document Management System
"everything" is documented and traceable, which means
for example, that documents are never deleted (unless the system
is configured to retain only a fixed-length document history,
e.g., only documents and version no older than 10 years old).
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 may be
required to explicitly "check out" the respective
documents from the repository, and check new versions into the
repository with notes and documentation regarding the nature and
purpose of the edits.
- On check in, the program can be configured to perform the
configuration-specific verification and documentation
maintenance operations. For example, it may require the users to
complete a check-list or a custom form, stating the purpose of
the edits or a brief summary of editing activities. The system
is fully programmable during installation, so that custom
reporting, annotation, signatures, or other requirements
associated with the creation or editing of documents can be
enforced.
- Summary options are available to allow authorized users to
review the complete audit trail for requested documents.
- The "length" of the auditing trail (i.e., for how
long back in time different versions of documents are stored)
can be configured. If desired, the different versions of
documents can persist indefinitely.
- If a backup function is not automatically performed as part of
the standard maintenance of an existing database installation or
data warehouse (where STATISTICA Document Management System
stores the repository of all documents and versions), the STATISTICA
Document Management System can perform regular system
backups.
- Various options are available to perform simple or complex
searches of the documents and different versions of documents
managed by the STATISTICA Document Management System.
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
various file formats, including your proprietary formats, allowing
it to share information internally in ways that are most convenient
for your specific organization, as well externally with practically
all industry standard applications or protocols for information
exchange.
Most importantly, the program allows you to save results reports
as PDF files, and data files or results tables in XPORT
files. These formats are the preferred file formats, recommended in
the FDA "Guidance for Industry: Providing Regulatory
Submissions in Electronic Format - General Considerations."
Open Architecture System
Like the entire STATISTICA system, the STATISTICA
Document Management System program is completely programmable,
and all of its functionality is accessible to other applications;
thus the system can be customized to accommodate highly
domain-specific tasks, and can also be integrated seamlessly into
existing systems for data and document management.
Please also inquire about the compatibility of STATISTICA
Document Management System with the Open Document Management
API (ODMA) standard, and the interfaces and support for the Web-based
Distributed Authoring and Versioning (WebDAV) standard.
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