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06/2010 Belgian Maintenance Manager of the Year 04/2010 Armstrong Building Products oders API PRO 11/2009 New version API PRO Open.7 released 08/2009 API PRO academy opens 07/2009 API PRO at Berglandmilch dairy 06/2009 New API PRO Job Request Portal released 06/2009 Web based API PRO solution available 06/2009 SP04 for V5Xa has been released 02/2009 Success in 2008 for API Maintenance Systems 10/2008 API PRO at MAINTAIN 2008 09/2008 Toyota chooses API PRO 08/2008 SP03 for V5Xa now available 08/2008 API wins large order in Germany

Validation

API PRO Validation Package

API Maintenance Systems has many customers within highly regulated industries, such as pharmaceuticals and food. These industries invest time and effort to achieve and maintain regulatory compliance. The validation is used to verify that the system reliably performs exactly as specified in the requirements. Several validation projects have been performed when implementing API PRO in these regulated industries. There has never been any difficulty receiving on time validation of the system. Download brochure below to gain more information about API PRO Validation Package.

Download brochure

21 CFR Part 11

21 CFR Part 11 applies when using a computer system to create, modify, transfer or store an electronic presentation of any information or process that is regulated by the FDA. API PRO can be used in both GMP and non-GMP regulated areas and this requires the system to be in compliance with 21 CFR Part 11. The purpose of the document below is to describe the features and functions in API PRO which are in compliance with 21 CFR Part 11.

Download API PRO 21 CFR Part 11 Statement