Electronic document management

Another important aspect for discussion is the impact of regulations, spe-cihcally the regulation on electronic document management and electronic signatures, 21 CFR Part 11, published by the Food and Drug Administration (FDA) for the hrst time in 1997 [1] (also see Chapter 26, which covers 21 CFR Part 11 in detail). Since that time the draft rules of Part 11 have been withdrawn and reissued along with various guidance documents [2-3], Some of the key points of Part 11 are as follows ... 

DIA Electronic Document Management Meeting, February 13, 2003 (Posted February 24,2003)... 

Electronic Submissions to the FDA, Randy Levin, MD, Fifth Annual Electronic Document Management Conference, September 23, 2002 (Posted November 14, 2002)... 

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document as such, and users notified that they are responsible for checking before use whether the document has been superseded.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. 

Version Security. In the paper world, archival documents held in a file room are in some sense final drafts. Security for a product document must be determined by its status. The electronic document management environment in which documents are managed across their entire life cycle by its very nature allows for the inclusion of draft materials. So, in addition to permitting or disallowing the viewing of the final version of a file, the electronic world must consider and secure access to draft versions. Usually, only authors, editors, and reviewers of files have access to the drafts before they are finalized. Once files are promoted to final status, this version is then promulgated to a broader readership. The draft versions, by contrast, may continue to be accessible by the authors, or may be locked or purged from the system. 

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

Table 1 Pros and cons of paper-based and electronic document management...

Electronic record—Information recorded in electronic form that requires a computerized system to access or process it. ERMS—An electronic records management system is an IT system using computer equipment and software to electronically manage electronics and nonelectronic records according to accepted principles and practices of records management. It is different from an electronic document management... 

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. 

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