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Our Validation Services Team solves your GMP challenges

Validation and QualificationSince 2001, Tanis Technical has been helping a wide range of international Life Sciences companies and equipment manufacturers document, test and validate their systems to ensure GMP compliance.  In addition to equipment qualification services (facility, utilities, packaging, process and lab equipment) we specialize in IT validation services, including hardware, servers, software and networks--we are your one-stop shop for Validation services!

In today's complex regulatory environment, GMP requirements are often changing and Quality Assurance and Validation resources are stretched.  Maintaining compliance is a difficult task for many manufacturing facilities.  Increasingly, pharmaceutical, biopharm and nutraceutical companies are outsourcing their qualification and validation services activities.  An outside validation supplier encounters new equipment on a regular basis, and will be able to augment your resources should you have an experience or availability gap.  This results in shorter and more efficient validation cycles, allowing you to increase compliance and decrease production delays.

Let us help augment your pharma QA and Validation program to increase compliance, sales, internal controls, and efficiency by using our Validation Services Team to develop Qualification Protocols, SOP's, specification documents, best practices and guidelines.

Contact us to find out how Tanis Technical can streamline your validation process.

Validation/Qualification/GMP Services

 
  • IQ/OQ/PQ/FAT/SAT protocol generation and execution
  • Full range: IT, Packaging, Process, Laboratory, Utilities, Facility
  • GMP Training
  • Equipment Design Review for GMP's

Equipment

 
  • IT Systems (routers, servers/services)
  • Packaging Equipment (tablet counters, liquid fillers, cappers, vision systems, labelers, clamshells)
  • Process Equipment (fluid bed dryers, spray dryers, coating pans, tablet presses)
  • Utilities (USP water, DI water, Clean Dry Air, Dust Collection, HVAC, Gas Systems)

Technical Writing

 
  • Manuals: User, Administration, and Maintenance (especially useful for equipment manufacturers)
  • Online Help files
  • Standard Operating Procedures (SOP)
  • Process Descriptions and Procedures
  • Policy Documents
  • URS, FRS, DDS Specifications