Manage your Training Records and Meet all of your Regulatory Requirements

5 Apr 2006

Autoscribe Training Manager may be deployed as a single user off the shelf product that may be further fully configured and expanded, if required, into an Enterprise solution meeting all of your regulatory requirements.

Autoscribe Training Manager enables you to take an 'active' approach to the management of employee training records.

Regulatory Compliance

If you work in a regulated industry, government or similar department or work to a Quality Management System then it is essential that you are able to show that your Training Systems are well managed and comply with the requirements of regulations such as:

ISO 9001 4.18

Defines the training requirements for ISO 9001 compliant organizations and demands that you: “Develop quality training procedures”

ISO 17025 for Calibration and Test Labs

Covers how the training of staff is determined, delivered, and documented. It defines the requirements for managing the identification and delivery of necessary training to meet the ISO 17025 quality system requirements.

Regulatory Authorities Audit and the public assumes that you have well managed and documented evidence of management of training records and requirements is part of all regulatory requirements:

Eg GLP, GMP, GxP, GAMP, GALP, FDA, Food and Drug Regulatory Authorities, Healthcare, Clinical, EU, EPA UKAS, etc.

Eg FDA ORA-LAB.5.2 - Directors Responsibilities

  • Ensures implementation of training procedures
  • Ensures resources are allocated for identified training within budgetary constraints
  • Responsible for the evaluation, training and growth of the technical and quality related skills of employees by establishing training schedule and rotation for all new employees and by ensuring personnel receive training and demonstrate competence
  • Ensures training is accomplished
  • Submits documentation for completed training for entry into training database or Integrated Management of Personnel

Autoscribe’s Training Records Management system actively notifies users, supervisors and the appropriate management team of the current status of employees training records, requirements, courses attended or to be attended, course / course vendor evaluations and comments etc. Automated reports can be sent by email to all users and can be viewed or printed out on demand. Delivery of the Training Management System can be implemented on client/server and / or web browser or over Citrix.

The user interface in Training Manager may be tailored by either Autoscribe or by an authorised user to very closely match individual requirements of customers. This is achieved using Autoscribe's suite of unique configuration tools. For example, customers can easily add or remove functionality by enabling or disabling parts of the user interface. This also makes validation of the deployment simpler for highly regulated customers.

The separation of the user interface from the data and business logic layers also allows different application clients to use both Windows and Web forms at the same time. Any changes made to the user interface by use of the configuration tools are reflected in both the Windows and Web forms simultaneously and are fully supported by Autoscribe. Hence the Training Manager System can be accessed directly or via the internet using the same screens.

Training Manager can be supplied in one of three formats as follows:

An out-of–the-box product complete with example reports A highly configurable system that allows screen and terminology changes with an optional report generator for creating additional reports A highly configurable system that allows screen and terminology changes with an optional report generator for creating additional reports with a bi-directional interface to Autoscribe's Matrix Laboratory Information Management System (LIMS).

Training Manager - Benefits

  • Ensures that SOPs, QMS and ISO / Regulatory body procedures are followed
  • Ensures that the training budget is used to best effect by recording course details and course evaluations
  • Ensures easy compliance with company quality systems by managing all aspects of employee training
  • Simplifies quality audits by consolidating training data
  • Provides early indication of staff strengths and training needs by storing course attendance and attendee performance records
  • Ensures staff training levels are current by automatically scheduling refresher courses

Autoscribe Training Manager is:

  • Easier to Use
  • Faster to Implement
  • Better by Design

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