Products

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Validation Suites

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Standard Operating Procedures

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Training Materials

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Normal Lab Values

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dsNavigator Integration Suite

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Database Maps

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Simple Forms

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OCEx

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DCIcopy

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SAS Product Suites

BioPharm Systems has developed procedural documentation packages to assist companies establish process standards in the following areas of: IT Operations, Clinical Data Management, and Product Safety.

These packages provide a basic set of Standard Operating Procedures (SOPs) and Guidelines defining the technical and process requirements for efficiently planning, preparing and managing your organization in the above areas. Each package is comprised of the following components:

• Higher-level SOPs (some are generic in nature, while others are specific for the use with a particular system, e.g. Oracle Clinical).
  
• Guidelines presented in a visual format, detailing how each procedure is performed.
  
• Forms and templates to be used with the procedures.
  
• Standards for critical functional areas.
  
• Roles and responsibilities table defining who is responsible for performing individual functions within each SOP and Guideline.
  
• A slide presentation with instruction on how to customize the documentation.
  
• Worksheets to help you customize the SOPs and Guidelines for your company's environment.

To obtain samples of our procedural documentation or to ask questions, please contact us at sops@biopharm.com.