Pharmaceutical Validations need to incorporate USP, ICH, cGMP and cGLP guidelines depending on the application. IIS can provide not only the industry guidelines for your validation project, we can also inform you of industry practices.

Every pharmaceutical company is unique in the way they run their organizations because most of the guidelines set forth by the FDA are vague. Recent staff acquisitions within the validation services department from pharmaceutical companies have strengthened the validation services department.  These acquisitions have given IIS a clear edge over the competition. Our Validation Services Department is abreast on the current pharmaceutical industry standards because we recruit employees with pharmaceutical company backgrounds.

Do not be fooled by considering cheap and dirty qualification alternatives.  Other companies may offer low cost options for qualification, but ask those companies if they are using 21 CFR Part 11 Compliant Equipment!  Ask those companies for complete certification for their equipment!  Ask those companies if they have ever been audited for quality before!  ASK THOSE COMPANIES BEFORE THE FDA ASKS YOU!  It may make your choice for quality validation easier.