Life validating

Engaging in youth and voluntary work can offer huge benefits to young people, not least of all the development of important life skills.

In spite of the existing evidence of such impact, adequate recognition and validation of competences gained through non-formal education is still lacking.

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Without traceability there is no evidence that the intended system purpose have been met.

Computerized system might be incomplete and inconsistent as well as gaps may creep when going live.

This can not only lead to compliance issues but also to higher additional costs in operations.

Creating and maintaining a traceability matrix for your computerized systems can relieve this challenge and provide an effective and efficient solution to describe and trace the life of requirements, in both a forward and backward direction.

All validation activities will have value in the project itself when integrating it with documenting the business process and requirements as well as the system design, development, building and testing.

Having a scope and strategy as well as a clear change management process in place are key aspects of validation process.

2) No matter what – rules are rules and rules are not negotiable Patient safety, data integrity and product quality are not negotiable, likewise mandatory regulation, for example FDA 21 CFR part 11 and Annex 11 established by the EMA.

The regulatory requirements of a business process shall not be underestimated when defining user requirements.

Most Member States are still a long way from having validation arrangements, and the space for the voluntary sector in it is limited or non-existent.

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