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Keywords

with, QUMAS, document, users, DocCompliance, content, regulatory, that, system, Management, Compliance, compliance, business, Enables, user, Part, Read, System, Table, security, Content, Review, Report, access, your, Flexible, Office, Control, electronic, efficient

Transcript

QUMAS Pre-defined Packages Concept
Overview
QUMAS DocComplianceTM is the cornerstone of the QUMAS Compliance PlatformTM. As an off-the-shelf web-based regulatory
content management system, DocCompliance ensures enterprise-wide consistency and compliance. The solution enables
organizations to create, manage, and securely store documents, using built in password policies to protect against
unauthorized access. It contains full support for Electronic Signatures as per FDA 21 CFR Part 11 requirements. Best practice
document management workflows ensure that the correct content is created, reviewed, approved, consumed, distributed and
retired. It encourages optimum content management through built in best practices. Flexible configuration enables you to
easily mirror your existing organizational structures and practices, and the intuitive user-interface ensures ease-of-use for all
end users. DocCompliance can be used in conjunction with MyQUMASTM, which provides access to the full capabilities of the
QUMAS Compliance platform including flexible business process management, learning management, business intelligence
and content collaboration.
Key Functionality
DocCompliance consists of the following main elements:
• Content Management and Advanced Search and Retrieval
• Flexible Process Control and Configurable Reports
• Built-in System Administration
• Secure Audit Trail
• Automated Version Control
• Automated PDF Rendering
DocCompliance can be used to manage a wide variety of controlled content, including:
Policies, Procedures, Standard Operating Procedures (SOPs),Work Instructions, R&D Documentation (Clinical, Regulatory,
Manufacturing), Legal Documentation, Sales and Marketing Collateral, HR Policies and Reports including CIAs.
Compliance
DocCompliance provides a comprehensive framework to achieve sustainable compliance supporting the most stringent
requirements such as:
A comprehensive audit trail allows users to complete point in time reporting for the purposes of regulatory audits and
investigations, returning the appropriate information to the investigator in an efficient manner.
Complete Electronic Signature Manifestation Displays all electronic signature components including printed name of signer, time/date stamp and meaning of signature.
FDA 21 CFR Part 11 All approved documents include an electronic signature which demonstrates compliance to 21 CFR Part 11 guidelines.
Role-based Electronic Signatures Meaning of signatures is synonymous with user role to ensure electronic endorsements match user intent.
Comprehensive, Independent Audit Trail Independent, secure audit trail capturing 270+ auditable events.
Hardcopy Management
Reports on sensitive documents that need to be destroyed or returned
and confirms by electronic signature when the document is actually
destroyed.
Automated Version Control Removes the risk of users accessing outdated versions of documents.
Read & Understood Accountability throughout the organization by ensuring traceability.
MyQUMAS
DocTransfer
DocComplianceTM
Pr c ssCompliance
TM

TM
 Ent rpris Risk TM
EnterpriseScanning
ComplianceLMS
ComplianceUnity
QUMASSDK
Eve tHandler
ComplianceMap
Robust Regulatory Content Management
Compliance Table
Features Benefits
Retire Create
Review
ApproveDistribute
Consume
1
2
34
5
6
DocComplianceTM
Closed-Loop
Compliance
• FDA 21 CFR Parts 11; 210; 820; 600 • ISO standards (9000; 1400) • GxP practices
Robust Regulatory Content Management
Flexible Workflow Control
The DocCompliance workflow engine is an intuitive end to end workflow solution. The process takes the content from its
initial creation either by template or desktop selection and uploads it to DocCompliance. Collaborative authoring and review
is then completed whereby multiple Authors/Reviewers can simultaneously comment and propose changes to the content in
an efficient fashion.
On completion of the review the content is routed forward to the approval step in the workflow where the electronic
signature is applied in compliance with 21 CFR Part 11 guidelines.
Once the document is authorized and made effective it allows for the consumer users, with the correct permissions to
complete Read and Understood training, view, search and print the document for the duration of the lifecycle. A periodic
review is typically conducted after a configurable period of time, to ensure content accuracy and validity. Ultimately when the
document has reached its end of life it is retired and removed from the view of the consumer users.
Workflow & Configuration Management Flexible business process workflows allow users to easily map their unique business processes to the system without customization.
Flexible Workflow Processing Enables efficient management of in-process workflows without complication or compromise of regulatory diligence.
Change Request Tracking Tracks change requests in accordance with GxP and GAMP guidelines.
Controlled Printing & Watermarking Effectively tracks and controls all printed and hardcopy documentation in accordance with regulatory guidelines.
User-Definable Change Dictionary Enables users to easily categorize change request rationale for effective tracking and statistical monitoring.
User-Definable Retention Policies & Expiration Helps users manage document policies in accordance with regulatory requirements.
Advanced Lifecycle Management Management of complex or simple document lifecycles at your fingertips.
Automated Notification & Distribution Enables effective distribution and rapid notification of document changes and approvals.
Formal & Informal Review Process Allows adaptable business processes based on formal or informal workflow policies.
Cooperative Review Allows one or more users to approve/disapprove on behalf of a group.
Read & Understood Enables users to mark information as Read & Understood, and to define distribution and notification lists.
Collaborative Authoring & Reviewing Allows multiple users to comment on and edit the same document in ‘real time’ or asynchronously reducing review times and review cycles.
Document Comparison Full document comparison enabling users to identify changes between versions of documents.
DOCUMENT LIFECYCLE MANAGEMENT WITH QUMAS DOCCOMPLIANCE
RetireConsumeMakeEffectiveAuthorizeApproveEditCreate
Workflow
Coordinator
Editor
Approver
Authorizer
Consumer
Initiate
Create/Activate
a Review
Collaborative
Review
Revise
Sign-off
Auto
Promote
Sign-off
Authorize Make
Effective
Controlled
ArchiveSearch/View/Print
Periodic
Review
Advanced Search and Retrieval
The DocCompliance advanced search and retrieval module allows the user to generate searches on documents and workflows.
The searches can be filtered on key criteria such as core system attributes, document title, name, author, creation date etc., but
in addition client specific attributes can be searched against to further filter the data, for example, product name, disposition,
supplier, dosage etc.
The advanced search module ensures that the user is presented with the current version of the document in an efficient manner
from one centrally located database. The search results can then be exported and printed to be distributed as required.
User-Definable Saved Searches Facilitates the reuse of user-defined searches to improve efficiency and consistency.
Public and Private Searches Promotes consistency and security across the organization through sharing of public searches and security for private searches.
Content and Attribute Searches Enables enhanced regulatory intelligence through attribute and content searches.
Built-In System Administration
The DocCompliance administration module allows administrators to manage users, group and roles profiles in conjunction
with the core components such as document types and workflow types. The use of groups and roles ensures that best practice
security parameters are in place, and that users have access to only the components of the system that they have permissions
over. Configuration wizards allow for easy administration of the system to scale as the organization grows over time.
User Profile Manager Establish access and security profile for each user, enabling access and control in compliance with current regulations.
Configurable Security Model Requires minimal technical experience, facilitating easy deployment.
Multiple Roles/User Support Enables the configuration of a user with one or more roles. Minimizes administration and configuration burdens.
User-Configurable Parameters
All system administration parameters are configurable such a groups, roles,
departments, etc. enabling easy adaptation to your production environment
without customization.
User-Definable System Preferences System preferences may be defined according to regulatory requirements or industry best practices i.e. password expiration.
Configurable Content Types DocCompliance can be used to manage any type of regulatory document. Each type of document is configurable or content that needs to be controlled
Built-in Best Practices Promotes and drives the use of best practices to address GxP, 21 CFR Part 11, and other global regulations.
Out-of-Office Settings Avoids system bottlenecks by allowing users to designate when they are out of the office and to specify role substitutes.
Easily Localized Interface Easily adaptable to any local system environment.
Securely Manage All Controlled Content across the Organization
Flexible Workflow Control Table
Features Benefits
Advanced Search and Retrieval Table
Features Benefits
Built-In System Administration Table
Features Benefits
QUMAS Pre-defined Packages Concept
Reporting
DocCompliance reporting provides the user with access to over 20 preconfigured reports* providing them with business critical
information in relation to their compliance needs.
Active Workflows Report Delivers a comprehensive summary of all active workflows and controlled processes.
Comprehensive Audit Trail Report Tracks over 270 auditable events delivering the most comprehensive support for this 21CFR Part 11 requirement.
Point-in-Time Reporting
Allows business users to build reports on the fly, detailing which versions of policies
and procedures were in effect on a particular date (point in time) or at the time of an
adverse event (without the need for consultants or IT resources).
Table of Contents Delivers a written taxonomy of your regulatory compliance portal at a glance.
Document Details Report Summarizes the complete revision history of any document within the system to ensure compliance.
Controlled Copy List Facilitates efficient hard copy management.
Out–of-Office Report Delivers an overview of all users that have activated their Out-of-Office settings.
Security Violations Report Convenient summary report that helps administrators to track security issues.
Read and Understood Report Delivers a detailed list of all Read and Understood signatures by document or by user.
Permissions Reports Enables system administrators to capture at-a-glance all group, user and object permissions to maintain security and access requirements.
Integration with SAP BusinessObjects
Enterprise
Extensive reporting capabilities are provided through full integration with
SAP BusinessObjects Enterprise.
* For configurable reports with analytical and graphical drill-down functionality please refer to the QUMAS ComplianceUnity
datasheet.
System Requirements
Platforms
• Available on Documentum 5.3 and 6.5, Oracle 10g and
11g R2, Microsoft SQL Server 2005 and Microsoft SQL
Server 2008
Third Party
• IIS 6, Office 2003, Office 2007, Office 2010, XP and Internet
Explorer 7 and 8; Acrobat Reader and Adobe Acrobat 9
or higher
Reporting
• Integrated with SAP BusinessObjects Enterprise XI v3.1
About QUMAS
QUMAS is the leader in Enterprise Compliance Management
with more than 250 global customer deployments and over
17 years experience within the Life Sciences sector. QUMAS
provides a closed-loop Compliance Platform that enables you
to integrate the common elements of compliance, including
content, processes, people and systems, across your
organization. QUMAS Solutions and Packages for document,
quality and incident management, submission management
and regulatory approval enable you to accelerate your time
to market, decrease compliance risks, improve operational
efficiencies and reduce overall quality costs.
Contact Us for More Information
Free Phone U.S Tel: 800 577 1545
NJ Office Tel: 973-805-8600
Cork, Ireland Office Tel: +353 (0)21 4915100
Email: info@qumas.com
Visit: www.qumas.com
Reporting Table
Features Benefits
QUMAS is a registered trademark. QUMAS Compliance PlatformTM, QUMAS DocComplianceTM,
QUMAS ProcessComplianceTM, MyQUMASTM , QUMAS ComplianceUnityTM are trademarks of QUMAS.
All other trademarks used herein are the property of their respective owners.
© Copyright 2011 QUMAS. All rights reserved.

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