Documentation Management Systems

The basis for your program plan should be your team s assessment of the current PSM status (Figure 4-11), which will have yielded a list of deficiencies compared with the required PSM elements. These gaps must now be translated into statements of required tasks, which in turn suggest work products for inclusion in your implementation plan. For example, your assessment shows that the process knowledge and documentation management system needs improvement. To address this gap you need to plan a series of tasks. 

Links to document management system for regulatory reports and submissions... 

Employee believed he was using the correct version of the procedure, but due to defects in the document management system, he was using an out-of-date edition... 

Use a good document management system and stress to the team that almost any document generated may become part of the public record. 

The design of control and monitoring instrumentation and regulating devices should be based on an established document management system that enables preparation to be formally approved, implemented, recorded, and audited. Typical contents and document deliverables of an integrated engineering documentation system are as follows ... 

Can be readily coupled into both LIMS and Document Manager systems for regulatory purposes. 

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document as such, and users notified that they are responsible for checking before use whether the document has been superseded.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

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