What are the main reason for that situation ?
The globalisation of the life science market has got created new challenges for the 21th century, based on :
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|  | economical concentration of the life science industry. The Top 10 worldwide players produce more than 60% of the global production.
| | the technological evolution allowed by the "e-approach" changes dramatically the organisations, the information, the systems, including the automation systems and the qualifications systems. The flexibility means for a supplier or for a partner of the life science industry to integrate this evolution in the shortest time.
| | the changes as described before concern also the lifecycle of the products and all the qualification aspects. Being flexible means that the conformity aspects must automatically be taken into consideration.
| | shorten the just-in-time is not sufficient from the manufacturing point of view. The deliveries include hardware, software, services, engineering, trainings, qualification,... Documentation has to be considered as an important part of the challenge. What's not documented is not done ? |
Flexibility is this kind of key requirement for the manufacturers, which copes with a day after day increasing turbulent environment.
Concerning the instrumentation, the flexibility has to focus on examinating with the different parties and responsibilities ( end users and third parties ) that the functional specification sticks as well as the design specification to the User Requirement Specification. This approach eliminates all the possible mistakes, providing the U.R.S. is welldone and complete.
Process and environmental conditions are defined, performance and design controlled and accepted, qualification and documentation listed including the trainings trainings.
The ability to change demonstrates the capacity and the the capability to react in case of need. Change control is an integral part of the flexibility aspects !!
A flexible partner contributes to :
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| | reducing the production costs.
| | lightening the maintenance structures.
| | diminishing the delivery times.
| | increasing the constance of the global quality.
| | raise the value of the efficiency.
| | facilitate the planning of the drug manufacturer. |
Changes are chances, aren't they ? |
