FDA RECALLS PART 11 GUIDANCE DOCUMENTS - NNE HAS THE FOLLOWING COMMENTS

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FDA RECALLS PART 11 GUIDANCE DOCUMENTS - NNE HAS THE FOLLOWING COMMENTS
04 March 2003 - NNE A/S

NNE considers FDA's announcement to be in line with the industry's desire for a more realistic and pragmatic compliance policy with focus on compliance with the intention behind the rule. That is, to ensure credible and reliable data handling of the electronic GxP data required in Predicate rules, and earlier controlled on paper. With reference to the new guidance, further possibilities are now opening up to the industry to prioritise the systems processing these electronic records in relation to data that has formerly been in a grey zone.

NNE considers FDA's announcement to be in line with the industry's desire for a more realistic and pragmatic compliance policy with focus on compliance with the intention behind the rule. That is, to ensure credible and reliable data handling of the electronic GxP data required in Predicate rules, and earlier controlled on paper.
With reference to the new guidance, further possibilities are now opening up to the industry to prioritise the systems processing these electronic records in relation to data that has formerly been in a grey zone.

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About: NNE A/S
With more than 80 years of experience, the engineering company NNE is a leading supplier of systems, consultancy and engineering services to the international pharmaceutical and biotechnological industry.

Our competencies span all technical disciplines applying to engineering, construction, validation, start-up and optimisation, and reconstruction of facilities for product development and production plants, pilot plants and laboratories within the pharmaceutical and biotechnological field.

Our unmistakable, clear client focus, combined with a flexible and integrated organisation where engineers, architects and pharmacists work closely together, puts us in a position to deliver customised solutions, ranging from stand-alone services to turnkey plants - quickly and safely.

NNE operates at an international level. We have worked on and completed a large number of projects both in Denmark and the rest of Scandinavia, and we have constructed biotechnological and pharmaceutical production facilities in USA, China, Japan, Brazil, and France.

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