PharmDev Innovations

PharmURS Support

'If I'd have asked my customers what they wanted, they would have told me "A faster horse."' Henry Ford

'A lot of times, people don't know what they want until you show it to them.' Steve Jobs (as quoted in BusinessWeek (1998-05-25))

Experience has shown that a lot of people have difficulties in setting up user requirement specifications (URS).

Many clients have considerable difficulties to articulate their ideas about needs and nice-to- haves of their projected process equipment, buildings, IT systems, business processes development objectives etc. and have them documented in a structured manner accordingly.

A user requirements specification, however, forms the elementary base for nearly all investment projects, all equipment qualifications and most validation projects in the process environment.

Furthermore it is as target setting prerequisite needed for most measures in context with organisational development and improvement of business processes.

In the area of pharmaceutical development a well structured definition of objectives is also needed as starter for the subsequent logical steps. In the language of ICH Q8 (QbD) we talk then about QTPP (Quality Target Product Profile).

Making use of established methods used in requirements engineering we'll help you to articulate your needs, provide a respective structure and document them accordingly.

Precise enough ?

The dilemma of precisely describing one's requirements is admittedly not restricted to pharmaceutical industry.

If you want to see an example from an other industry click here.

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