This is the second part of a two part article. (See Part I)
Once an electronic system has gone through the validation process and is in production, users can access it to initiate, review, and approve documents in accord with the SOPs against which they have undergone training. The validation process will have set specifications for the system based on user requirements, so the system will be able to accommodate all the documents the system has been built to hold and to identify users by passwords linked to the users' names.
The first step in creating a new document in a new system is to ascertain whether the document is actually needed. A brand new system is not searchable, so initial determination for a document needs to be based on the former system. If a document is necessary, reviewers confirm within the new system and the author can begin to prepare a document. Typically, system administrators make templates available to authors so that they can generate a new document.
To make the system fully usable and searchable for the categories of documents the system will ultimately house, legacy documents must also come into the system. There are a few approaches for building the document repository in an electronic system.
How the documents come into the system must be considered and subsequently documented in an SOP that covers the transitioning phase. The SOP can be retired when the system is fully loaded. The former system must stay up and running until all documents have either been retired or transitioned to the new system. Then the old system and its SOPs can be retired.
Companies also need to have an SOP in place for handling legacy documents that may continue to be generated outside the system; such documents may be study protocols or reports prepared by contractors, for instance. Importing these documents into the system can follow the same process as the process of bringing in pre-existing documents.
In new systems, many companies determine to simplify conventions such as the numbering system and formatting for specific types of documents, and the transition period is a good time to undertake such an activity. If the document conventions are predetermined, they can be applied before a document enters the system.
Documents that are ready for review can also undergo reformatting -- but not content changing. This is possible if the original system has secure electronic files of the final approved document. A reformatted document can then be imported into the system, checked for exact replication (quality control check) as the approved, signed document, and put into review. It is not the best idea to scan versioned documents because the text will have to be re-created anyway for updating during the review cycle. If the numbering system has changed for the new system, the document history in the electronic system should identify the previous number and version and link it to the new number. This history links the e-file in the new system to the document from the former system.
The next procedures to address are those that require updating before their periodic review cycle. Many companies set priorities and determine which of these documents should enter the system first. Bear in mind, however, that they are still active in the older system and will continue to be until they enter the new system. These can be imported the same way as other SOPs.
Janet Gough is a consultant to the industry specializing in document management, standard operating procedures, and technical and medical writing. She is a course director for the Center for Professional Innovation and Education. She is the author of 11 industry books, including Risk-Based Software Validation: 10 Easy Steps, and Write It Down: Guidance for Preparing Compliant and Effective Documentation (CRC Press). She and co-author David Nettleton are currently working on a Q&A book on Document Management for John Wiley & Sons. She can be reached at firstname.lastname@example.org or http://www.gxpdocumentation.com.
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