| Validation
is the most crucial step in realizing the completion of
a pharmaceutical construction or update project. Simply,
without adequate validation, multi-million dollar
pharmaceutical facilities become nothing more than
over-priced real estate. CTTI
methodologies have demonstrated success with many of
the industry’s most demanding validation
projects.
Our methodologies include:
• Process Validation: Using risk-based tools to
identify critical process parameters and demonstrate compliance with predetermined specifications while avoiding
redundant testing or over-validation.
• Computer Systems Validation: Executing computer
systems validation studies in parallel with equipment
qualification to save time and money, including software
& hardware vendor audits and quality assurance plans.
• Cleaning Validation: Using standardized procedures
and methods to maximize the effectiveness of cleaning
validation.
• Analytical Methods Validations: Evolving from
standardized protocols and instrument tests for standard
laboratory equipment, which permits you to focus on
managing your laboratory.
• Equipment Qualification: Merging commissioning
and validation documents together in a way that streamlines
installation and operational qualification.
• Facilities and Utilities Qualification: Establishing
robust lifecycle models for facility and utility qualification
covering vendor assessments, modular testing and final
reports.
•
Development of Equipment Master Data: Registration and
creation of Assets and task list as per equipment
manufacturer’s recommendation.
Canadian
Technology Team Inc
123 White Blvd
Thornhill
ON - L4J 5Z1
Canada
Phone:
1-866-209-8842
Email: info@cantechteam.com
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