Tanis Technical Inc. - Validation Services and GMP Compliance

Sunday, Sep 05th

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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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Intro to 21 CFR Part 11

Intro to 21 CFR Part 11

The breather is over! Avoid 483's and Warning Letters. Study Part 11!

The FDA has indicated that they will shortly release their approach to inspecting Part 11 controls.  Their inspections will be…

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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...
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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