• General Contractors
• FDA Regulated Industries
• Equipment Suppliers

General Contractors:

The Situation... You've just received the RFQ for a new design-build project--a 200,000 sq. ft. pharmaceutical manufacturing plant. The RFQ requires inclusion of validation for the facility, including new pharmaceutical process equipment, utilities, lab equipment, and the facility construction itself.

The Strategy... Maintaining a validation department is an expensive proposition. Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMP) are ever-changing guidelines for the Life Sciences industry. They need to be interpreted and understood by experienced personnel, and they need to be followed. You can either maintain a staff of costly validation personnel, or you can contract with us.

You build great buildings--we validate them.

Tanis Technical Inc. will consult with you through the bid, design, build, and validation process to ensure your facility, equipment and documentation will suit your customer's requirements, and the FDA.

Why Tanis Technical?...

• Complete validation services on all equipment, utilities and facility
• Validation protocol creation and execution
• Guidance on drawings and documentation
• Facility design review
• Help with Engineering, QA and Regulatory Affairs communication
• Factory Acceptance Test (FAT)

FDA-Regulated Industries:

The Situation... Money is tight. Resources are even tighter. You've got new equipment coming in, and some that's due for re-validation.

The Strategy... Many companies do not wish to maintain a staff of costly validation experts due to the sporatic need for their services. That's where Tanis Technical Inc.'s team of Validation Engineers, Project Managers, and Technical Writers can help.

Tanis Technical Inc. has professional staff and contract Validation experts available to work with you on your short- or long-term project. We offer complete solutions from Validation Master Plans to Protocol Execution and follow-up, including complete overall Project Management if required.

Why Tanis Technical?...

• Validation Master Plans
• Qualification protocol generation and execution
• SOP creation and training
• Computer Systems Validation
• Competitve costs, Industry experts, Flexible resourcing

Equipment Suppliers:

The Situation... You're trying to increase sales to the Pharmaceutical or other Regulated Industry. With the shrinking of internal support staff within the Life Sciences industry, the industry is turning to the Equipment Designers and Builders to provide Validation along with the equipoment. Trouble is, you don't have a Validation Department.

The Strategy... Maintaining a validation department is an expensive proposition. That's where Tanis Technical Inc.'s team of Validation Engineers, Project Managers, and Technical Writers can help. We'll write the Validation protocols, then execute the tests at your customer's facility. You increase your sales, and your exposure to this profitable market.

Why Tanis Technical?...

• Validation Master Plans
• Qualification protocol generation and execution
• SOP creation and training
• Computer Systems Validation, Functional Requirement Specs
• Instruction and maintenance manuals
• Competitve costs, Industry experts, Flexible resourcing