Document Management & Control

Transcription

1 Document Management & Control ibpms Business Process Applications (BPAs) are the innovative, new class of Service Oriented Business Applications (SOBAs) that help businesses automate and simplify the management of mission-critical, complex enterprise business processes. Using ibpms Documents, customers have optimized operational efficiency, achieved lower operational costs, and improved customer satisfaction while reducing errors, increasing agility and time to market in implementing a complete and integrated solution for knowledge management, document control and records management. ibpms Document Manager Document Management Document management solution (DMS) becomes more and more important because companies are managing documents as knowledge, content, records to support their business processes. Managing of documents includes the creation, storage, organization, transmission, retrieval, manipulation, update, and eventual disposition of documents to fulfill the organizational purpose improving communication among people and groups of people and at the same time being compliant with regulations and standards. The Process of Managing Documents To help customers accelerate their BPM initiatives and reap the rewards as rapidly as possible, ibpms Team as developed a complete process enabled application dedicated to manage and control documents with internal and external capabilities. As a process it is suitable to be adjustable to your requirements and to be the perfect solution to manage your documents and records. This ibpms Application include process templates, end user forms, maps, rules, and other process components all centered on managing and control documents. Management and Control In process management, internal control management, regulated environments, FDA and ISO environments, document management and control is a key to attaining quality and compliance. Controlling documentation requires an effective document control system. ibpms Documents automates and effectively manages document control process to help ensure compliance with FDA 21 CFR Part 11 regulations, ISO standards, Sarbanes-Oxley Act, and other regulatory requirements. Multi-Company, Multi-Site Companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate systems, especially paper-based or hybrid document control systems but in medium term, however, these systems are inefficient, requiring tremendous man-hours in terms of preparing workflows, routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss 1 11

2 is built on a state-of-theart business process management software platform for developing and deploying agile solutions connecting users, applications and systems within and outside an organization to close critical gaps and streamline missioncritical business processes. It supports and integrates multiple enterprises simultaneously while ensuring solution interoperability and scalability when the enterprise environment grows. changes, and manual search and retrieval of documents during operation, inspections or audits. ibpms Documents is prepared to support multi-company, multi-site implementations saving thousands of man-hours to accurately manage your documents. Rapid User Adoption ibpms offers document management using familiar interfaces to get rapid user adoption built on a repository that offers transparent, out-of-sight services for full ECM. Virtual File System Replace shared drives and offer the same interface; Like Rules Configure plug in rules to automate manual processing and offer out of sight compliance with the powerful capabilities of the workflow configurator; The possibility to add Google like Search; Automatic meta-data extraction and categorization based on process forms; Best practice collaboration spaces based on domains; Transparent Lifecycle support; Content Contribution; Portal Access compatibility. Efficient Document Control System ibpms Documents automates routing and delivery of all type of documentation trough a powerful workflow configuration based on process design and execution engine. It's uniquely qualified to be the focal point of management systems because it can handle all types of documents regardless of the software used to create them. It provides a powerful action oriented approach using the BPM engine to process To Do Lists and Watch Lists. It provides also a secure document control repository that makes search and retrieval easy. It is Web-based so documents are accessible to all authorized users from virtually anywhere. Document Revision Control In a paper-based system or basic portal hybrid systems, employees check out documents and other materials (engineering drawings, etc.) manually and there is a lack of control over the older versions. Tracking down any document activity is difficult. Making a change in an SOP or other document requires manual submission of a change request or discussion of the change in face-to-face 2 11

3 The ibpms is secure and easily deployed either at the customer site or hosted off-site. Its Web-centric, service-oriented architecture enables the secure online exchange of business documents and high volume Internet transactions all with the highest levels of adaptability to customer environments. The vast array of client interface options and flexible, open architecture make it the ideal solution for automating, managing, and controlling the unique, human-based and often complex processes that drive organizational success. Scalability and high-performance are inherent meetings. With ibpms Documents it is possible to do this automatically because the workflow acts not only on documents but also on folders and it keeps all records to support the complete audit trail including, messages exchanged, older version and older version history, control on signed documents, etc. Automated Document Revision Control ibpms Documents provides automatic revision control and related history with a complete audit trail to ensure that only the current version of a document is available. Changes can be initiated and approved electronically. When a user makes a change the user must enter a reason and a description for the change. The system tracks these changes and makes them available through information screens and reports. It always ensures users are able to access the right document any time. Integrates Training with Document Management Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage. Ineffective communication can lead to delays and poor results. ibpms Documents is an integrated process solution that connects other process applications like CAPA, change management, audit, internal control, process management, performance, customer complaints, and training for example. It can also, when integrated with Training Manager to start automatically a necessary training action. Insight It's difficult to generate accurate and timely reports and trends using disparate tools (electronic spreadsheets, flowcharting software, paper documents in binders). Without an effective reporting tool, managers are unable to get control of their quality management system. ibpms provides advanced analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a real-time view of the documents that support their processes and can be more proactive about improving their management systems. Metadata Metadata is typically stored for each document. Metadata may, for example, include the date the document was stored and the identity of the user storing it. With the ibpms Capture the system also uses optical character recognition on scanned images, or 3 11

4 Resources are allocated for an individual transaction and freed upon completion. As a result, a higher order of requests can be processed with the absolute minimum of resource requirements. On the other hand pooling and resource management techniques are utilized so that overhead of resource instantiation does not counterweight the benefits of stateless design. performs text extraction on electronic documents. The resulting extracted text can be used to assist users in locating documents by identifying probable keywords or providing for full text search capability, or can be used on its own. Extracted text can also be stored as a component of metadata, stored with the image, or separately as a source for searching document collections. When integrated with Mail Room, Doc Manager is an effective solution to manage all correspondence. ibpms Documents integrates with Microsoft Word to automate document properties (metadata) in order to guarantee no errors on new revisions and releases. Integration ibpms Documents integrate document management directly into other applications, so that users may retrieve existing documents directly from the document management system repository, make changes, and save the changed document back to the repository as a new version, all without leaving the application. Such integration is available for office suites and or collaboration/groupware software as services. Integration often uses open standards such as LDAP, and SOAP to allow integration with other software and compliance with internal controls. Capture Images of paper documents using scanners or multifunction printers can be used to initiate other processes and be retrieved using the ibpms Documents capabilities. Optical Character Recognition (OCR) software is used, whether integrated into the hardware or as standalone ibpms Capture component, in order to convert digital images into machine readable text. Indexing Indexing may be as simple as keeping track of unique document identifiers but with ibpms Documents often it takes a more complex form, providing classification through the documents' metadata or even through word indexes extracted from the documents contents. Indexing exists mainly to support retrieval. One area of critical importance for rapid retrieval is the creation of an index topology. Also ibpms Documents works with Google Index System and can use the Google Search capabilities to improve the access. 4 11

5 Storage Storage of the documents often includes management of those same documents in Archives. Where they are stored, for how long, migration of the documents from one storage media to another (Hierarchical storage management) and eventual document destruction can be configured on ibpms Documents and there are special roles to do that as standard features. Retrieval Although the notion of retrieving a particular document is simple, retrieval in the electronic context can be quite complex and powerful. Simple retrieval of individual documents can be supported by allowing the user to specify the unique document identifier, and having the system use the basic index (or a non-indexed query on its data store) to retrieve the document. More flexible retrieval allows the user to specify partial search terms involving the document identifier and/or parts of the expected metadata. This would typically return a list of documents which match the user's search terms. ibpms Documents provide also the capability to specify a Boolean expression containing multiple keywords or example phrases expected to exist within the documents contents. The retrieval for this kind of query may be supported by previously-built indexes and Google Index System as an option. Distribution Document security is vital in many document management applications. Compliance requirements for certain documents can be quite complex depending on the type of documents and ibpms Documents supports those types of requirements. It supports roles and rights management that allows an administrator to give access to documents based on type to only certain people or groups of people. Because it is a process enabled application access is controlled by roles as the system understands the user and what he can do. ibpms Documents is also able to publish documents in PDF Format even if the working version for document manager will be a word version for example. Also notifications can be sent with a web link trough and include also the possibility for acknowledgment receipts forcing the user to see the publish version. Workflow 5 11

6 Workflow is a complex problem for most of document management solutions. For ibpms Documents this is a built-in capability because the BPM Engine uses a powerful workflow engine. It supports manual workflow requiring the user to view the document and decide who to send it to and at same time rules-based workflow allowing an administrator to create a rule that dictates the flow of the document through an organization: for instance, an invoice passes through an approval process and then is routed to the accounts payable department. With static but also dynamic rules it allow for branches to be created in a workflow process. Collaboration Collaboration should be inherent in an DMS. Documents in ibpms Documents are capable of being retrieved by an authorized user and worked on. Access is blocked to other users while work is being performed on the document. Also users can contribute to the document with information and improvement opportunities. Versioning Versioning in ibpms Documents is the process by which documents are checked in or out of the document management system, allowing users to retrieve previous versions and to continue work from a selected point. Versioning is useful and sometimes mandatory according standards and regulatory systems for documents that change over time and require updating, and it becomes easy to go back to a previous copy. Also, ibpms Documents is able to use approved templates to facilitate the creation of documents with workflows and versioning for templates and also for the documents themselves. Automations In this version, it is possible the automatic codification that allows you to maintain the uniformity of the codes applied to documents and is particularly useful when you want the option of active unity of codes. Furthermore, this suggestion of coding may be according to the Document Type. This version can set automatically the code prefix for each document type, facilitating thus the selection of the document type at the time of insertion / creation, the prefixes can be defined in the previously set by Document Type. 6 11

7 Possibility of establishing a single, standard footer on all Excel documents and PPTs. Possibility to configure what is the default revision to apply to new documents. This feature allows you to set default revisions facilitating the use and applicability in the management and document control. This new version aims to ensure uniformity of coding / version of the documents included therein. Possibility of text construction as a watermark to be applied to convert documents to PDF with fields automatically. This version has the selecting functionality of one or more documents and sending them as an attachment in an , directly from the list of documents to facilitate their distribution. In this version will be available to a user not Manager of workflows to choose a different workflow for the document in question ever the folder where the document is inserted has available the option of modifying workflow. The documents location mechanism has been improved significantly allowing now get the location in the document structure, even in situations where there are several alternative paths to them in order to build the functionality of related folders. Possibility of publication in PDF locally and on External Portals. 7 11

8 Facts ibpms Documents Process Application has been successfully implemented, validated and inspected in different environments without any instances of non-compliance since its introduction in Now in version 4.1, it includes many features and requirements which came from the large utilization in companies from different size and dimensions including the possibility to publish a document trough many portals using different languages using web services. Dramatically increases the knowledge management capabilities, the control and reduces the time by speeding up the process for document change, approval, notification, and distribution. As a Process Enabled Application is a very configurable product designed for rapid installation, implementation, and validation. Ensures documentation integrity so employees always have the most updated document at their fingertips. Core Capabilities Metadata: with capabilities for permanent and temporary documents, publish dates, forecasted revision dates, key words, related objects, references, comments, messages, etc; Workflow: Combines powerful electronic routing and approval using workflow configuration because it uses the BPM Engine strong capabilities; Standards: Supports industry-standard databases and is compliant with ISO, CFR 21, DOD, MultiReq, SOX and other document management standards and requirements; Revision Control: provides automatic document revision control to ensure that only the current version of a document is available. When a user makes a change in the properties the user must enter a reason for the change. The software tracks all changes made; Related Objects: Provides a unique function to related different documents with different folders with workflow integration; Solid Audit Trail: Provides a secure, time-stamped audit trail exceeding 21 Part CFR 11 requirements. The Doc Manager documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made. Security: With ibpms Documents, documents are stored in vaults located in a central database for access by authorized users only. The software automatically locks both login and approval anytime either one is compromised. Advanced Tracking: ibpms Documents tracks documents by status or history. A document will show as either "in process" or "complete" if tracked by status. The revision or approval history of documents can also be reviewed using the history feature. Analytics and Reporting: ibpms advanced analytics and reporting capability provides standard and customized reports to help increase management oversight. Electronic Sign-offs: With ibpms Documents, documents can be signed and approved electronically. Signature manifestation name, date, time, and meaning of electronic signature can be appended automatically to each document. Manage Different Document Types: ibpms Documents is uniquely qualified to be the focal point of any compliance initiative because it can manage different documents-based processes and handle all types of documents regardless of the software used to create them. Easy Access: ibpms Documents is Web-based so it can connect all employees involved in 8 11

9 document and quality control from virtually anywhere. Provides a centralized repository for easy access, search, and retrieval of documents by all authorized users. Automates Routing, Escalation, and Approval: Reduces document cycle time by automating routing and approval and incorporating escalation for overdue tasks. Dependent Routing: Completion of a task can be made dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task. Streamlines Collaboration: Creating and revising documents as a team is easier because it provides a collaboration workspace that allows input from other collaborators, avoiding duplication. A rejected document is automatically returned to the originator for a new task, so rejected packets don't languish in the system. Also, it can work on the first rejection from a group of people or wait till the last users approves or rejects. Integrates with Other Applications: ibpms Documents can integrate with other process enable applications directly without any extra work or applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs. Pre-Defined Workflow: Company-wide policies, SOPs, and other documents that require inter-departmental collaboration move along pre-defined workflows, from one department to the next. Overdue tasks automatically escalate. Automation of Forms-Based Processes: Form processes unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be integrated with document-based processes under one secure repository. A department can keep the look and function of existing forms or create entirely new ones because it is a process enabled application. Easy to Search: A standardized search window is available throughout the application, which means all authorized users throughout the organization can search for tasks, training records, policies, and other documents using a familiar search interface. Also as an add-on it is possible to implement the Google index and Google Search Engine on the File System. Easy to Find: ibpms Documents navigator, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Domains and documents can be stored in multiple folders. System administrators can control and automatically update the documents through a dynamic link. Favourites: Provides the opportunity to manage and organize documents as favourites; Multi-Portal Broadcasting: Provides as an add-on the possibility to publish the same document in different portals and centralized control of that publications with web-services capabilities. Addresses Multi-Language Publishing: Provides trough the Multi-Portal function the possibility to specify the language of the document to be published. PDF Conversion: As an add-on contains a PDF server with strong capabilities for document PDF conversion including a unique feature which allows working and revising the document on the native version and converting it to PDF when the users see it. Metadata Integration with Microsoft Office: Integrates the metadata with Microsoft Office providing inside Word ibpms properties to automate the document. Shared Repository: Allows for other ibpms Applications to use the Doc Manager as a repository in order to get meta-tags info automated. Template Routing and Approval: Similar to other document, templates can be published and approved with workflows being released to be used as approved templates when creating a new document. 9 11

10 Links: Provides the capability to work with links like documents. ZIP and UNZIP: Provides to the users the capability to insert a ZIP folder and the ibpms Documents. Manager unzips the folder automatically in order to load the document. Subscription: Allows users to subscribe documents being part of the notification list. Notifications Lists: Provides the capability to create notifications list with or without acknowledgement receipts. integration: All messages and actions are sent to system in order to provide access to the users. Document Stamping: Provides the capability for stamping using the doc properties integrated with Microsoft Word or PDF Stamping. Recycle Bin Management: Uses a Recycle Bin to manage all recyclable documents and allows users to recover those documents to special domains and folders. Archive Management: Provides a complete archive management with features to manage records with timelines and to archive and un-archive documents with user actions or pre-defined rules. Free Viewing Portal: Provides for uncontrolled documents or controlled documents with full viewing access the possibility to use a viewing portal that does not require access control. To Do Lists and Watch Lists: Because it is based on a process framework it produces To Do Lists and Watch Lists as necessary for all users with alarm signals and alert messages. Audit Trail: Full audit trail and reporting. Electronic signature: management and control (add-on). Compliance: Ensures 21 CFR Part 11 compliance with security and integrity of documents. Validation: Computer systems validation plan and implementation. Open: Scalable, open systems architecture

11 About VP Consulting VP Consulting is a leading Business Process Management consulting company working on Europe region and with operations in Brazil, with deep experience in Business Process Analysis & Modeling (BPA), Business Process Management (BPM) and Governance, Risk and Compliance and designing and implementing BPM solutions at companies in every industry. VP Consulting is implementing a partner network offering marketleading solutions and has developed ibpms Process Enabled Applications to help customers accelerate their BPM initiatives and reap the rewards as rapidly as possible. For more information please consult and