Training Plan software

Even if the software supplier is to be the primary source of training, it is important to establish a comprehensive training plan as an integral part of an overall simulation strategy. The training plan should include the following major areas ... 

GMP risk assessment Qualified/trained resource System life-cycle validation System environment Current specifications Software quality assurance Formal testing/acceptance Data entry authorization Data plausibility checks Communication diagnostics Access security Batch release authority Formal procedures/contracts Change control Electronic data hardcopy Secure data storage Contingency/recovery plans Maintenance plans/records... 

Performance Monitoring SOP Review Elec Ironic Data Records Software Records Calibration Records Life-cycle Documents Internal Audits Maintenance Plan Health, Safety Environmental Plans Training Records Contingency Plan De-commissioning Plan... 

When selecting from a choice of software products, the director of pharmacy should consider the products vendors. The company s good reputation and its ability to provide referrals from former and existing clients are essential. Installation planning should be suitable for the organization s needs yet realistic for the vendor. While the vendor is responsible for system design, much of the installation, education, and training of employees will fall on the shoulders of the pharmacy department. 

Validation test environment including hardware, software System security including passwords, network rights, functional security, physical security, modem access and virus protection Validation test environment including related documents, along with standard operating procedures, user manuals, and system development/ maintenance and documentation Validation assumptions, exclusions, and limitations Responsibilities matrix Validation data sets Acceptance criteria Expected results Execution of the validation plan Resolution of errors Documentation Training records... 

Once the causes of problem performance have been identified, then you can plan for fhe solutions (Table 7.3). For example, if you determine that employees are not successful because fhey do nof know how to perform the task, providing training may be a simple solution. For instance, if you have asked your secrefary to prepare a presenfation for you in PowerPoint, but he or she has never used the software before, if is likely thaf fhe outcome will not be positive for either of you. 

All documentation furnished by the supplier should be available. User manuals, as-built drawings, instrument calibration records, and procedures for operation and maintenance (including calibration schedules) of the system should all be checked to verify that they are suitable. Supplier documentation should be reviewed for accuracy in its specifications of the various versions of software used and approved as fit for purpose. It is recommended that checks are made to verify that contingency plans, SOPs, and any Service Level Agreements (SLAs) are also in place. Any specific competencies supposed to be acquired before the IQ/OQ/PQ through training should also have been achieved — these records should be checked. 

After the testing is complete and the code is corrected for errors, the software is released for production and distribution. The product is considered ready for release when it has met all the criteria specified in the quality plan and after formal sign-off by product line, quality assurance, and manufacturing management. A prerequisite for this is sufficient training of service engineers who must be able not only to install and operate the software but also to train users and answer users questions. Availability of user documentation in the... 

An alternative is offered by advances in computers and software, which make it possible to address the essential training and operational requirements more conveniently and cost-effectively. In fact, such computer-related tools could also help formulate responses to unintended releases of conventional chemicals and hazardous materials. Thus, if developed, such computer-related tools could permit first-responders to enhance and sustain their ability to assess and plan for variety of different situations. 

The products identified may be technical ones, such as software components and their supporting documentation, management products, such as plans and reports of various types, or items that are the by-products of processes to ensure software quality, such as testing scripts. The products may be ones that will be delivered to the customer (deliverables) or intermediate products created at various stages of the project for internal purposes, for example, to clarify and communicate design decisions between members of the development team. The concept of a product is a broad one, so that a person could be a product (e.g., a trained user ) or the product could be a revised version of a previously existing product (e.g., a tested program ). 

Take credit (i.e. reconsider the failure mode or the probability or the severity) for diverse or redundant systems, training or competence, operational history or history of similar systems, use of established technology, reuse of software, test plans and results, coverage of tests, safety managanent practices, etc. 

The integrated data package includes the technical design information for the life cycle processes, and the special equipment specifications and baselines, software code listings, technical manuals, technical plans, facility drawings, and special tools related to manufacturing, verification, distribution, operations, support, training, and disposal. 

Hierarchical Task Analysis (HTA) (Aimett, J., Duncan 1967) is a process for developing a description of tasks in terms of operations (things people do to reach goals) and plans (statements of conditions that tell when each operation is to be carried out). HTA has been mostly used for the design of training. Its merit is mainly the clear representation technique. HTA is cinrently supported by a software www.taskarchitect.com... 

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