Electronic Change Management Systems

Electronic Change Management Systems with PSSR Tools... 

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. 

TRANSFUSION, MURPHY, M. R, STAVES, J., DAVIES, A., FRASER, E., PARKER, R., CRIPPS, BKAY, J VINCENT, C. "HOW DO WE APPROACH A MAJOR CHANGE PROGRAM USING THE EXAMPLE OF THE DEVELOPMENT, EVALUATION, AND IMPLEMENTATION OF AN ELECTRONIC TRANSFUSION MANAGEMENT SYSTEM". 49, NO. 5, 829-837, 2009. REPRODUCED WITH PERMISSION FROM WILEY-BLACKWELL)... 

Murphy, M.F., Staves, J., Davies, A. et al. (2009) How do we approach a major change program using the example of the development, evaluation, and implementation of an electronic transfusion management system. Transfusion, 49(5), 829-837. 

The ECRI Institute s Top 10 Health Technology Hazards for 2014 places neglecting change management in networked devices and systems at number seven [2]. The report cites several examples of incidents including an update to an electronic health record which resulted in the loss of date and time data from radiology reports. 

A dramatic decrease of the time of analysis can be achieved by using narrower columns combined with an adjusted improved electronic pressure control system. As today in most forensic science laboratories the procedures developed with the normal capillary GC instrumentation are part of a quality management system, a major change using the possibilities of Fast GC requires a new validation. This, together with the high level of performance reached during the last 15 years in capillary GC, may to some extent slow down the process of innovation in this area. 

A common software tool some companies have adopted is an electronic management of change (MOC) system. There are numerous approaches to doing this. Some software is commercially available, other software is customizable for the client, and still other software has been developed in-house or in close collaboration with a custom software application development partner. 

Some fairly common mistakes made in managing electronic SOPs, protocols, and changes to them are listed below. If these can be avoided, the resulting computer system should meet the requirements of the US, Organization for Economic Cooperation and Development (OECD), and Ministry of Health, Labor, and Welfare (MHLW) GLP standards as well as the FDA s Rule on Electronic Record Keeping Electronic Signatures. ... 

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