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Who are the stakeholders involved in the requirements validation process? and How the techniques and the approaches of requirements validation?

Biotech companies are among the most intensive instrumentation users of any FDA-regulated business.

Because of the complex nature of these companies' research and manufacturing, they typically have a larger number of instruments per employee.

Most biotech startups begin the process of managing calibration by developing simple spreadsheets or databases.

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This paper will review the evolution of validation techniques and their current status in Requirements Engineering (RE).

The following three examples illustrate implementation and configuration for various company sizes of our customers.

Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages.

As time wanes and resources evaporate, companies (specifically in FDA-regulated industries) cannot afford to develop in-house systems that improve productivity and manage compliance.

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Today VALIDAT supports validation documentation according to regulations for our customers in pharmaceutical, chemical, or biotechnical industries, in petrochemistry, materials test, or in car industries: reliable, professional and secure.

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Qualification of systems and equipment is therefore a part of the process of validation.

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