Electronic Document Management Systems

Chapter 34 Case Study 16 Electronic Document Management Systems (EDMS).765... 

Uncontrolled copies should be identified on the document as such, and users notified that they are responsible for checking before use whether the document has been superseded. If an electronic document management system is in place, it should ensure that printed paper copies are endorsed to the effect that the paper copy is not an authoritative document but simply a copy of an electronic master at an instance in time. 

The most common observation made by the FDA concerns the lack of (or incomplete) audit trails. This is often associated with the incorrect identification of electronic records. Specifically, the Warning Letters referred to Chromatography Data Systems (CDS), Electronic Document Management Systems (EDMS), Databases, Batch Records, Change Records, and Device History Records. 

Medical Device Measurement Systems Statistical Analysis Systems Labeling System Electronic Document Management Systems... 

Electronic regulatory submissions combine components from specific systems, e.g., computer-aided review tools and electronic document management systems. Electronic publishing systems assemble electronic documents and images into electronic dossiers. The validation requirements of the publishing system, over and above the requirements for each component system should be assessed. 

Document management refers to procedures or systems designed to exert an intelligent control over the creation, management, and distribution of documents. Electronic document management systems (EDMS) may include any or all of the following features ... 

The problems associated with the management of paper can be overcome by implementing an electronic document management system (EDMS). 

Artwork needs to be agreed upon between the pharmaceutical, medical device, or healthcare company and the marketing organization. Traditionally this has been achieved using fax and/or e-mail attachments. More recently the Intranet and Internet has been used to facihtate such transactions in conjunction with electronic document management systems (EDMS). 

If electronic SOPs are managed through a validated Electronic Document Management System (EDMS), it could be argued that it is not necessary to validate the intranet environment as the EDMS qualification would have effectively qualified it. The intranet would only have to be validated in its own right where its functionality is not limited to library viewing and read-only access. The qualification approach to EDMS is discussed in Chapter 34 Case Study 16. 

Table 3 Validation of an electronic document management system...

An electronic document management system is used for the maintenance of corporate and local standard operating procedures (SOPs). It includes functionality for document control, but also a workflow component for creating drafts, reviewing, approving, and distributing documents and supports electronic signatures... 

The traditional records management model is based on cabinets, folders, and files. This physical model was given its logical extension in the first electronic document management systems, where files were placed into virtual cabinets and folders. 

The true business value of an EDMS is realized to the extent that it serves as more than just the terminus for document-related activities in an enterprise. To fully realize its goals, an enterprise paperless documentation system will perform functions across the entire document life-cycle. In addition to the storage of existing documents, users with appropriate system privileges must be able to create new electronic documents from within the electronic document management system. The system must explicitly support the file formats used by the business, which typically include word processing, spreadsheet, graphics, and database files. 

An enterprise EDMS must be flexible enough to accommodate documents that do not originate within the system. It must be possible to import documents whether they are electronic or paper in format. Technologically speaking, there are no constraints on the files that can be stored in modern electronic document management systems. It should be noted, however, that certain file types (e.g., databases) cannot be rendered meaningfully to certain standard immutable display formats (e.g., PDF) and will often be viewed by default as read-only in the authoring application. 

Electronic document management systems have the ability to distribute documents based on permissions or access control lists (ACLs). Document consumers can be notified automatically of a document s availability in the system. Once a file s status is updated to final or approved, a message can be automatically sent to members of a distribution list alerting them that it has been published. Access to the document can be further streamlined by attaching to the email a pointer to the file in the EDMS. 

Users with appropriate system privileges must be able to view documents. Typically, documents to be viewed in an EDMS are presented as read-only files, either in the authoring application or a standard immutable file format such as TIFF (Tagged Image File Format) or Adobe s portable document format (PDF). By virtue of its flexibility and platform-independence, PDF has become the storage standard in contemporary electronic document management systems. Most systems will automatically create PDF files and provide the PDF rendition in response to a user view request. 

An electronic document management system is a configuration of design tools, data capture tools. 

There are some features that you may want to consider if your facility is building or buying an electronic document management system... 

Multiphase development tracking. To mana a large procedtue effort, you may want to record the writers, reviewers, sponsors and subject matter ejq)erts who participate in the development of each procedure. You may want to track the progress from draft to approval. Certain electronic document management systems will help you do this. 

Periodic review scheduling. An electronic document management system can act as a tickler system to assist in scheduling periodic procedure reviews. An electronic database system can automatically start a clock each time a procedure is approved and provide a monthly or weekly report on which procedures require review. 

Automatic indexing and transmittal. Once your hard-copy locations for procedure sets are identified, an electronic document management system should help you to know where procedure sets are located and who should receive new or revised procedures. 

Will electronic data management solve all your problems No, you will still need to maintain hard copy sets of procedures. As long as there are power outages and failed computers, hard copies should be maintained. An electronic document management system will, at the least, help you keep your hard-copy sets current and intact. 

IS refers to the software packages and databases that provide the functionality to implement the business processes. These include such packages as Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), Electronic Document Management Systems (EDMS) and Maintenance Management Systems. 

All real-time and historical information is stored on or available from the enterprise server. This can integrate information from multiple distributed applications and databases and consolidate the data into a single history system. This can then be made available as standard reports via networked printers or standard displays using Web browsers across the corporate Intranet. Copies of batch reports are written to local optical disks and also copied to the site Electronic Document Management System (EDMS) as a secondary backup and for long-term storage. 

EDMS = Electronic Document Management System MMS = Maintenance Management System BMS = Building Management System RCM reliability-centered maintenance SHE = Safety, Health and Environment OEM = Operation and Maintenance CMP = Good Manufacturing Practice IQ= Installation Qualification OQ = Operational Qualification... 

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