Validating adequacy and suitablity of business it

20 Apr

Our systematic approach to model validation ensures that all dimensions of your CST model development, implementation, and use (conceptual design, technical and statistical correctness, outcomes accuracy and controls) are effectively challenged and affirmed, thereby empowering you to meet your DFAST and CCAR compliance and capital management requirements.

Mountain View will perform a comprehensive validation of all models that support your capital stress testing regimen.

provide guidance on assessing the levels of validation required and the evidence required from a validation exercise, ?

give guidance on how external testing and documentation can be incorporated in the validation process.

In the pharmaceutical industry, countless HPLCs are working in research and quality control laboratories, churning out innumerable test results each day on the dosage levels, purity, and dissolution characteristics of new drug candidates or marketed products.

Now… how can anyone be sure that each HPLC autosampler is injecting precisely or that the column has not degraded the day before?

To validate CST models, Mountain View employs an end-to-end review process that is thorough, model-centric and entirely consistent with current supervisory expectations.

This is one question which companies are generally afraid to answer.

The current trend is moving towards a worldwide harmonization of Quality/Safety/Customer requirements for Biotechnology/Pharmaceutical, and Medical Devices. The Pharmaceutical, Biotechnology, Genomics, Chemical, and Medical Device supply chains are spreading into the developed and emerging markets, so it requires organizations to comply with stringent yet obligatory Quality, Safety, and Regulatory requirements in each geography where your products are distributed.

It includes consideration of how vendor and third-party testing can be used to assist this assurance process. provide guidance on the capture and analysis of functional and non-functional requirements relating to an Information Security (IS) incident investigation, ?

give guidance on the use of validation as a means of assuring suitability of processes involved in the investigation, ?