Project tracking, computer systems

All projects have a life of their own and each person has a different methodology and timing for getting the job done. Success in computer systems validation will depend on the operating committee s ability to keep the process moving. One means of project control is a tracking format that identifies the key steps in the validation process and the anticipated and actual completion dates. 

Actions and recommendations should be differentiated. Actions must be completed or must progress to an acceptable state before the computer system can be authorized for use. Open actions should be listed in the Project Compliance Issue Log (see Chapter 6). Recommendations are just that they do not need to be completed before the computer system is authorized for use. Followup audits should track actions and recommendations as appropriate in the context of that audit. The management of actions and recommendations are summarized in Figure 7.7. 

The successful development of a new pharmaceutical product requires careful planning of various activities and resources, as well as tracking the project s progress. A small project is not difficult to monitor manually however, multiple projects benefit from an automated tool to support the planning process as well as the monitoring of various activities. In addition, these systems will help develop what if scenarios for the resources in the new projects as well as help to terminate the projects. Several project management systems currently available on the market are designed to fulfill these needs. These systems are available for all types of computers—from personal computers to mainframes. 

Inventory control is generally in the form of log books or computer-based inventory systems. Chemicals are issued through written requests on prescribed forms, but there is no tracking of chemicals after they are issued to individual laboratories. No record of their use and disposal is kept. Bar codes and radio frequency identification tagging are available in some developing countries but are not commonly used for keeping track of where or how a chemical is used. Chemicals procured by individual faculty members with project funds are often not recorded in the central inventory faculty members are expected to add them to the central inventory voluntarily but have little incentive to do so. This is also true for laboratories in most developed countries. 

The visual perception of depth (when viewing 3D) data is helped enormously if the viewer can move the data himself. There are many depth cues (stereo, depth from motion, depth from perspective), but depth from motion is the strongest. That is why maximum intensity projections (MIP) are preferably viewed dynamically. By self-tracking also the muscle s proprioceptors are giving feedback to the brain, adding to the visual sensation. The combination with human s superb eye-hand coordination has led to the concept of the Dextroscope (www.dex-troscope.com), where a (computer generated) view or object can be manipulated under a half-transparent mirror, through which the viewer sees the display. Displays can also be equipped with haptic (tactile) feedback systems, which are now commercially available (Fig. 9.13). 

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