The client needed to improve the current CSV methodology, supporting CSV framework and quality model. They were seeking guidance to develop a CSV framework to support the implementation of technology solutions which will need to be validated. They needed an assessment of current validation needs, understand tool options, quality systems (procedures) and support the current compliance profile. They also wanted a “right-sized” framework for validation and quality/compliance that could scale to meet planned growth.
Hawkins Point leveraged our IT Quality Framework and accelerators to define and implement a right sized validation approach. We reviewed the current CSV process governance, procedures and existing methodology that were in place. We documented the current state of process and determined the desired outcomes. We delivered recommendations for Policies, SOPs, CSV validation templates. We provided guidance, job aids, and awareness training as function of client adoption.