GxP Lifeline Feature Article

Making the Transition to an E-System, Part II
by Janet Gough, Course Director, Center for Professional Innovation and Education

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.

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.

Versioned Documents

Typically companies begin to build a document repository by addressing their procedures; they handle documents such as work instructions and forms the same way. A reasonable place to start is by determining if any documents are ready for retirement. If they are, they can be put into review in the former system and simply retired within that system. They can also be brought in as any other SOPs that are ready to go into the review cycle, but then they must follow the SOP for importing documents to the new 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.

Other Electronic Documents

Protocols, amendments, reports and other documents and records that must be available for reuse can be handled the same way as versioned documents, since companies need to have electronic files for updates. The key is to ensure exact replication of the original signed document. Again, if the earlier system has a feature that ensures security of the electronic file, it can be imported with a quality control (QC) check for exact replication.

Manually Signed Documents

To import a document bearing a wet signature into the electronic system, FDA recommends PDF copies. For best readability and replication, these are the recommended resolutions:
  • Text 300 dpi
  • Photos 600 dpi resolution
  • Gels and karyotypes: 600 dpi; 8-bit grayscale depth
  • Plotter graphics: 300 dpi
  • HPLC: 300 dpi

The Quality Control (QC) Check

Each document coming into the new system, whether an electronic file or a scan, requires a 100 percent quality control check to ensure that documents and records are exact replicas (in keeping with the requirements of Part 11). A 100 percent QC check of text is verification of the number of pages, and confirmation that the first and last word. Images, diagrams, and photos require a visual confirmation that the copy is identical to the original. The QC check is ideally performed by a different person from the one who has done the actual scanning and the QC check is documented. Precise QC of documents and records make it possible for companies ultimately to do away with paper and use the electronic files as official records.

References

Food and Drug Administration (FDA) 1997. Electronic Records; Electronic Signatures, final rule. 21 CFR Part 11 Washington, D.C.: U.S. Government Printing Office.
Nettleton, David and Janet Gough. Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164. 2004. CRC Press: Boca Raton, FL.
Nettleton, David and Janet Gough. Risk Based Software Validation: 10 Easy Steps. Second Edition, 2006, DHI and PDA Publishers: Baltimore, MD and Moore, Oklahoma

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 janet.gough@gmail.com or http://www.gxpdocumentation.com.

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FDA Link

Guidance for Industry: Part 11, Electronic Records: Electronic Signatures---Scope and Application http://www.fda.gov/cder/guidance/5667fnl.pdf



Additional Article

Sherlock, Adam. "Automated Agility Boosts Use the of Electronic Document Systems." Scientist Live 05 January 2009. 13 January 2009. < http://www.scientistlive.com/European-Science-News/Opinion/Automated_agility_boosts_use_the_of_electronic_document_systems/21473/.