Take control of your pharmaceutical operations

In the pharmaceutical industry, the control of the operations is where the challenge really begins!

Indeed, the governmental regulations require the detailed recording and the documentation of almost all aspects of your activities. However, a powerful quality control would allow you to establish a positive image right from the start to avoid expensive recalls of products. Rapid cycles of development are essential to maximize the profitability of the products.

The software of JD Edwards EnterpriseOne gives you more control of your pharmaceutical operations, by giving greater transparency to your operations - while you focus and concentrate on your new ideas. Validation with integration while passing advanced tariffing and the follow-up of the batches, pharmaceutical solutions suggested by JD Edwards EnterpriseOne confer the power and the flexibility necessary for you to act and react quickly in a very regulated environment.

Validation
Other aspects of the pharmaceutical industry, that your information system must answer are the strict requirements in terms of operations and documentation. Oracle understands the highly regulated environment in which you operate, and can assist you in the implementation and the validation of its software.

The data-processing validation provides the documented proof, of a correct response from the system to any type of activity. Principal stages of a process of validation (integral part of the implementation of a pharmaceutical environment):

• Plan of validation
  This plan establishes the activities - and assigns the responsibilities - necessary to the validation of the software and the material infrastructure.
  
  
• Document of the functional requirements
  Bench marking starting from the observations and remarks of your employees, as well as documentation accompanying our software, this document specifies the functions fulfilled by the solution in your own environment.
  
  
• Qualification of the installation
  Checking of the conformity of the principal aspects of the PeopleSoft® solution for design, approved recommendation’s and specifications, together with approval of the user's manuals, versions of the programs, checking of the backup copies and the data-processing infrastructure of the application.
  
  
• Operational qualification
  Tests checking that the application and the information processing system meet all the operational needs for the users and the company. With this stage, all the interactions user application are documented in the form of standard procedures.
  
  Qualification of the performances: Functional check of the solution Oracle JD Edwards in your normal working environment.
  
  
• Final report/ratio
  A summary of the stages involved in the process of validation, with description of the problems and measurements taken to solve them.
  Once the final report/ratio has been approved, then your JD Edwards EnterpriseOne solution is then ready to be used.
  
  Of course, our engagement does not stop with the establishment of the final report/ratio. After the installation of a validated application, Oracle and InOne will help to maintain and manage this validation, for the long term - as part of our continued commitment to long term partnerships.
  So that with a combination of innovative methods, software development partnerships with specialists in this industry, you are ensured of quality in all aspects of your operation’s.
  
  Reduction in the process of validation of pharmaceutical solutions from JD Edwards® EnterpriseOne Solutions, have taken place on many sites around the world. Strict standards of quality, attentively selected partnerships and personalized tools have assisted in this reduction this process.
  
  
• Certification ISO 9001
  A symbol of quality universally recognised at both National and International level was obtained by PeopleSoft® after it subjected its internal system of quality to the process of certification of the ISO (International Organization for Standardization). After a rigorous examination of our procedures of development, the solutions OneWorld™ and WorldSoftware™ were certified ISO 9001. With this label, you can be certain of the quality of your JD Edwards® EnterpriseOne solution.