Name: Tsrd
Address: 193 Bchside Drv Vlomar A1, Luquillo, PR, 00773, USA
Telephone: (787) 807-7092

Who We Are

TSRD is a Puerto Rican company that had been recognized by our excellent and high quality services, on time results, low costs and our commitment to satisfy or exceed client expectations. During the past eighteen years, we are specialized in validation (Commissioning, Verification, IQ/OQ/PQ) and quality management (Auditing, Assessments, Regulatory Advise, CAPA, Investigation, Management Review, Annual Product Review, others) services to the pharmaceutical and medical devices industry.

Certified Minority Business (PR5646) winner of Class I - 2011 Supplier of the Year Award.

Our experience covers a broad range of validation, regulatory, manufacturing and quality services; from early product/process development stage to full scale operation and certification.

TSRD has the skills and tools to manage and deal with all phases associated with validation and quality services related to the majority of the pharmaceutical and medical devices technology. We bring to each assignment a team of highly qualified personnel, knowledgeable of the most recent regulatory, audit and technical procedures.

Vision
Our vision is to become your validation solution provider. To be recognized as the best validation team who helps our customers to achive their business goals.

Our Experience
Our personnel's expertise covers a broad range of validation, manufacturing and quality services from early process development stages to full scale operation and certification. Our staff has over 80 years of combine working experience in the regulated industry.

Mission
Our organization understands the needs of the industry and the rigorous requierements that our customers are required to fulfill. This is why our mission is to satisfy our clients needs on the quality management and validation process with a timely, cost effective and high quality service. We will fulfill our mission creating a strong partnership with our customers.

Services
TSRD has developed its project management control program based on years of experience in the execution of industrial projects in Puerto Rico and the United States.

Professional Services:
Develop Validation Master Planning.
Define Process / System Requirements (Specifications, Equipment, Procedures).
Develop, Execute and Provide summary reports for IQ, OQ and PQ protocols.
Evaluate GMP requirements including SOP's, Forms or General Documentation.
Specialized Trainings Development and Presentation.
Quality Audits as part of the "on-going system evaluation", Life Cycle Approach.
Troubleshooting of Industrial Processes.
Customized Seminars on selected validation topics to fit clients expectations.
Change Control, Validation and General Documentation Assessment.
Process / Systems Status Assessment.
Annual Reports Preparation.
Commissioning.
Factory Acceptance Test (FAT).
Site Acceptance Test (SAT).
Statistical Process Control (SPC).
Vendor's Certification / Vendors Audit.
Long Term Secondary Services (cost efficient), providing technical resources to execute tasks according to professional experiences and clients requirement .

Other Services:
Compressed Air Quality Monitoring; Hydrocarbons, Particulate Matter, Dew Point.
Environmental Conditions Monitoring; Relative Humidity, Temperature, Non-Viable Particulate.
Clean Rooms Classification / Certification According to the Regulatory Requirements.

Tsrd

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