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Actively Manage your Training Records
An
Autoscribe product story
Edited by the Manufacturingtalk editorial team
Jul 27, 2005
Autoscribe 'Active Training Manager' is part of a suite of software products developed by Autoscribe using Microsoft's.NET technology.
Autoscribe 'Active Training Manager' is part of a suite of software products developed by Autoscribe using Microsoft's.NET technology.
The system 'actively' manages Training Records using a protocol driven system and can be accessed directly or via the internet using the same screens.
Regulatory Authorities can conduct audits of company sites and quality systems.
The public and other companies with whom you conduct business, will also 'assume' that you have well managed and documented evidence of management of training records.
Additionally Training Record Management is part of all regulatory requirements eg GLP, GMP, GxP, GAMP, GALP, FDA, Food and Drug Regulatory Authorities, Healthcare, Clinical, EU, EPA etc.
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 Laboratories covers how the training of your staff is determined, delivered, and documented.
It also defines the requirements for managing the "identification and delivery" of necessary training to meet the requirements of the ISO 17025 quality system.
FDA ORA-LAB.5.2 defines a company's Director's Responsibilities as:.
* Ensuring implementation of training procedures.
* Ensuring 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.
* Ensuring that training is accomplished.
* Submitting documentation for completed training for entry into training database or Integrated Management of Personnel.
To meet ALL of these requirements and more please contact Autoscribe for further information.
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