Since 2001, Tanis Technical Inc. has been empowering the compliance personnel of highly-regulated companies and their suppliers by providing services that help our customers increase compliance, sales, and internal control and efficiency of business and manufacturing processes and documentation while achieving superior ROI from their technology investment in an era of market contraction, decreasing budgets, and increasing regulatory pressure.

Our staff experts and partners are well-equipped to handle your needs, from Pharmaceutical Validation to suit FDA, Health Canada or other agency requirements, to providing the consulting, hardware, software, and documentation solutions you need to ensure compliance.

Validation/Qualification

Tanis Technical's team of expert Validation specialists have world-wide experience helping our customers in the Pharmaceutical and Nutraceutical segments with their Validation challenges.  We provide IQ/OQ/PQ/FAT/SAT protocol generation and implementation.  We have strong partnerships with equipment manufacturers who service Life Sciences, giving us a superior insight into equipment qualification requirements. We cover the complete spectrum of equipment, including:

• 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)
• IT Systems (routers, servers/services) 

GMP Training

The cGMP Training Program is designed specifically to teach the “language” of the industry and to develop within attendees a good understanding of the requirements and regulations that control the day-to-day activities of a GMP facility.

• Module 1: Overview of Regulations and Validation and Documentation Concepts
• Module 2: General cGMP and Equipment Design Topics
• Module 3: cGMP Orientation
• Module 4: Standard Operating Procedures
• Module 5: Record Keeping and Quality Assurance
• Module 6: Cost Considerations in Validation 

Technical Writing

Our professional technical writers use advanced document design and control tools to create superior documentation, including:

• Manuals: User, Administration, and Maintenance Manuals for equipment manufacturers, as well as for in-house developed applications and systems.
• Help Files: Online Help files for you in-house developed applications and systems.
• Standard Operating Procedures (SOP)
• Process Descriptions and Procedures
• Policy Documents
• URS, FRS, DDS Specifications: User Requirement Specifications, Functional Requirement Specifications, Detailed Design Specifications.  Many Equipment Manufacturers turn to Tanis to create or respond to these specification documents for them.  See our Compliant Partners Program for more information.