So with the molding process, you can't just in spect a part and say 'yeah, this looks good.' We would either go through process
validation and supply our customer with parts, or we would test the parts--subject them to design verification testing.
Data
validation consists of the processes and technologies involved in ensuring the conformance of data values to business requirements and acceptance criteria.
The terms
validation and qualification are very often used interchangeably.
In some cases,
validation results show that these changes in strategies resulted in up to a ten-fold increase in the loss rates at certain score intervals compared with historical rates.
The benefits of data
validation processes included:
Her expertise includes reusable device reprocessing
validations, pharmaceutical testing, and microbiology testing.
In a March 2010 warning letter, the FDA cited Pierre Fabre for inadequate process
validation procedures.
The "ideal" situation is a
validation rules engine that enables each specific
validation rule to be enabled/disabled, and to provide lot different methods of handling exceptions.
* Qualification,
validation, and proof of stability of sterile barrier system (SBS) materials and seals
Other important elements of governance related to MRM include policies or best practices related to model development, testing, documentation, approvals, version and change control, access rights and
validation.