Total Compliance Services, LLC

Design Concept to FDA Approval

- Lab Automation design & Validation
- Automation & Control Systems Validation
- Information Systems Validation
- Equipment & Utility Validation
- Quality & Compliance
- Computer System Configuration
- Analytical Instrument & Laboratory Equipment Validation
- Other services: Project Leadership, Auditing, SOP Development,
& 21 CFR Part 11 Assessment and Remediation

Total Compliance Services, LLC

Total Compliance Services (TCS) was established in November of 2002 and operates in collaboration with Senior Employees and Principal Consultants from leading pharmaceutical, biotechnology, medical device firms, and tissue/organ banks; most have over ten years of experience.

Validation Plus: When on a project; our team will first align themselves with your company's policies and procedures. TCS structures its validation and quality programs to the client’s needs. Our senior and principle associates will provide process improvements to your programs through Gap Analysis. Whether you are required to meet local or corporate policies, we provide the talent to meet your request by identifying how to:

Ensure a successful project from start to completion
Ensure that equipment & Analytical Instruments will work as expected
Identify the warning signs of project failure, and what to do to ensure the project meets all compliance requirements.
How to factor quality into your decision for selecting a validation consulting firm

We are committed to perform projects successfully, identify and recommend solutions to your problems. The services of our Senior and Principal members include all phases of project management from concept design to FDA approval.