Validation Engineering
As part of the engineering process of product design and development QA-Base team will help our customer to build correct, and safe process, in order to enter an engineering stage in the right and most efficient way. As part of the processes we will help the customer to build specification for the product with regards to safety and expected risks and will supply a report to verify between the different activities and their related risk to the product, patient, or the organization.
Such risk assessment document will help the management and the engineering team to evaluate the best way to get progress with the development, and will allow to control which risks are reasonable to take, which risks are to much, and which processes will help in monitoring and reducing the related risks.
In addition, all the data that will be collected, results from experiments, reason for decision making, conclusions, decisions, etc – will be recorder in the correct and organized way, and will be specify in the QMS in the organization, so when the time will come – it will all be recorded according to standards, and will provide added value and maintenance of information in an organize way, so data will get lost during the time.
Al in all – the QA-Base team will help minimize development risks, crucial mistake, or fatal decisions, and will help the customer to manage its information in the correct and most efficient way.