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Validation and Qualification

Validation and Qualification

for your IT systems, utilities, facility, lab, packaging or process equipment

Tanis Technical's team of expert Validation specialists have world-wide experience helping our customers in the Pharmaceutical and Nutraceutical segments with…

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GMP and Validation Training

GMP and Validation Training

Comprehensive on-site training services

The cGMP Training Program is designed specifically to teach the “language” of the industry and to develop within attendees a…

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Technical Writing

Technical Writing

SOP's, manuals & specifications for equipment manufacturers and end-users

Are you an equipment manufacturer who requires manuals, standard operating procedures (SOP), policy or specification documents, or other compliance-support documentation?

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Can your compliance organization keep up?

Your Validation Troubles Solved!Changing regulations, advancing technology, shifting agency priorities... it's difficult for an in-house validation team to stay on top of it all.

Since 2001, armed with the latest validation methods and industry knowledge, Tanis has been helping a wide range of international Life Sciences companies and equipment manufacturers ensure compliance with GMP regulations. 

Read more about Tanis Technical...
or
Read more about how a Validation contractor can help...

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