Our process management and consulting services can help your biostatistical computing organization achieve compliance with regulatory requirements by assisting you in developing standard procedures and processes that establish documented evidence of the development life cycle of your statistical computing system.

Compliance with regulatory requirements involves providing documented evidence of the process and activities used to create, maintain and archive data and statistical output. Our major steps in helping you achieve regulatory compliance are:

• Evaluate your current biostatistical computing system, processes and existing documentation
• Identify regulatory gaps or deficiencies that exist in your current process.
• Establish a plan to address and correct the deficiencies
• Implement the process to correct the deficiencies
• Insure documentation of new and established procedures

We can focus on the entire statistical programming process or individual components of the process. Specifically, some of the key documents that we can help you create are:

• SOPs - Describes what needs to be done
• Plans - Describes how to do what needs to be done
  
• Software Development Forms - Documents the development life cycle of statistical programs
  
• Training materials - Assists in educating the users within the computing system