System Process Validation or Qualification

TSI CONSULTANTS SERVICES

System Process Validation or Qualification

TSI Consultants is available to help evaluate the adequacy of products, equipment, and facility. TSI consultants provide expert, unbiased assessments that help ensure that strengths are recognized and weaknesses are addressed.

TSI delivers both strategic recommendations and tactical, front-line support through services, including programmatic assistance, validation/qualification activities, and computer systems validation.

Programmatic Assistance

Validation/qualification policies, procedures, protocols, and master plans
Technology transfer programs—including processes, analytical methods, and changes
Staff training for ongoing validation programs
Program assessments
Process simulation programs (i.e., aseptic processing media fills)

Validation/Qualification Activities

Development and/or implementation of:

Validation of process, equipment, instrumentation, analytical methods, utilities, facilities and computer applications
Risk-based validation strategies
User requirements, functional and design specifications
Protocols, reports and test cases for IQ, OQ, PQ
Data migration and verification
21 CFR Part 11 System compliance assessments and training, including electronic signatures
Infrastructure (LAN and WAN) qualification
Specific requirements for analytical methods validation
Electronic tracking systems for validation

Development of support systems affecting validation, including:

Change control
Configuration management
Retrospective validation
Electronic signature certification and policy
IT security procedures
Patch installations, including virus/security
Periodic reviews
Electronic data integrity assessments

Computer Systems Validation and 21CFR Part 11 Compliance

TSI consultants are experts in:

Evaluating and enhancing systems to assure data integrity—covering collection, documentation, management, source data changes, and security
Assessing data integrity, whether voluntary or required by the DRAP

PHARMACEUTICAL

TSI Consultants has an unsurpassed reputation for excellence in technical, regulatory consulting

PHARMACEUTICAL

TSI Consultants is proficient in the development, implementation, and management of diversified projects involving compliance, scientific principles, technical aspects, and regulatory requirements related to pharmaceutical products.

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Medical Device

TSI Consultants comprehensive list of services extends to all classes of medical device.

Medical Device

TSI Consultants comprehensive list of services extend to all classes of medical devices and combination products including In Vitro Diagnostics, Integral, Cross-labeled and Kitted Combination Products.

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BIOLOGICS

TSI Consultants has a reputation for demonstrated excellence in technical, regulatory consultation,

BIOLOGICS

TSI Consultants has a reputation for demonstrated excellence in technical, regulatory consultation, and guidance services for biologics, including cell and gene therapy, human cell and tissue products, monoclonal antibodies, biosimilars and many more.

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