The IIS Documentation Services Department was created in 2002 as a spin-off of the Validation Services Department. Often times during validation activities, the appropriate documentation, especially standard operating procedures (SOP's), were not in place to fulfill the Installation Qualification requirements. Unfortunately, this led to delays in approving validation packages.
IIS can now provide assistance writing high quality, FDA/cGXP compliant SOP's for instruments, equipment and programs. Our staff will develop new SOP's or update existing SOP's, as applicable. These procedures can be written in your company's format, following your company's policies or can be stand alone, customized IIS procedures in our SOP program.
IIS offers customized procedures for Calibration Programs, Preventative Maintenance Programs, Monitoring System Programs and Change Control Programs.
Many companies have many different philosophies concerning SOP control. Some companies want their service providers to develop and control equipment procedures. Conversely, other companies prefer to take control of their programs and incorporate equipment procedures into their own SOP system. Either way, IIS will work with your company to ensure SOP control is maintained.