TCS offers a full range of commissioning, qualification, and validation services for your regulated facilities, processes, and equipment. Our methodology incorporates a risk-based approach, leveraging QRM principles, to meticulously assess and outline the CQV requirements for each project. By addressing the crucial elements necessary for compliance and system resilience with lean validation processes, we deliver considerable time and cost savings to our clients.
Quality Management Services
TCS provides Quality Assurance (QA) Project Management support for capital and strategic project endeavors, guaranteeing that deliverables and workstream obligations related to QA are addressed throughout the phases of design review, construction execution, and qualification. This helps our clients by:
- Accounting for cGMP (or GxP) rules, principles, and practices when designing facilities, utilities, and equipment.
- Overseeing the requirements and process flows of the quality management system (QMS) for the duration of the project, including change controls, controlled document generation, training records, etc.
- Working with stakeholders to create SOPs for equipment and processes (such as setup, operation, maintenance, shutdown, cleaning, entry/exit, periodic review, or any other required procedures).
- Drafting and/or reviewing all required project documentation, including submittals, drawings, contractor field reports, protocols, testing summary reports, impact assessments, validation and commissioning plans, risk analyses, progress reports, and more.
- Leading commissioning, validation, FAT, and SAT execution and/or oversight.
- Ensuring adequate handling of the project budget, the CQV timeline, and suppliers in relation to the QA workstream.
Commissioning Services
Commissioning and start-up of facilities, utilities, and equipment is a fundamental starting point for construction projects prior to turnover or qualification/validation activities. TCS offers comprehensive commissioning services to ensure your design intent is satisfied, your systems are installed properly, and equipment start-up executes per specifications and client expectations.
- Building / MEP commissioning:
- Multidisciplinary evaluation of IFC drawing packages, submittals, specifications, contractor field reports, and other relevant documents to ensure compliance with project specifications, applicable governing regulations/standards, and client procedures.
- On-site verification of MEP infrastructure and components to ensure strict adherence to proper installation, accessibility, cleaning, identification labeling, materials of construction, compliance certificates, and so forth.
- Efficient communication and proactive coordination with contractors to ensure thorough documentation and testing of mechanical, electrical, and plumbing systems during start-up.
- General project commissioning support:
- Development of commissioning plans – outlining all necessary and planned commissioning testing for each system within scope, including review with contractors and project team members for overall alignment.
- Creation and execution of commissioning checklists – to ensure design intent is fulfilled with proper, traceable documentation.
- Extensive field verification during and after construction to ensure design-to-construction alignment and to capture any discrepancies from IFC drawings.
- Issues/discrepancies log generation and management for resolution.
Validation Services
Validation and qualification processes are critical for ensuring user requirements are satisfied, process parameters are outlined, critical quality attributes are controlled, and required testing is documented to support use of the systems in daily operational practices.
- Validation planning – outlines of testing required, traceable to user requirements, system functional specifications, design requirements, and more.
- IQ/OQ/PQ protocol creation and execution – ensuring all necessary installation and operational requirements are addressed and clearly tested for compliance.
- Discrepancy reports – outlining any testing issues, shortfalls, or system failures that may impact the client’s product or operations, including any necessary adjustments or suggested changes needed to improve system operation for retesting.
Specialty Testing Services
Specialty testing is often required for advanced or complex manufacturing processes and facilities, to prove compliant operations within local, state, and government regulations.
- Airflow Visualizations (ISO 14644-3:2019, 21 CFR Part 211, USP 797 / 1116, Annex 1, etc.)
- Aseptic Process Simulations (PDA Technical Report No. 22, EU GMP Annex 1, etc.)
- Cleanability Studies / Cleaning Validation (ASTM E3106 / G122, ICH Q9, etc.)
- Computer Systems Validation (21 CFR Part 11, EMA Annex 11, GAMP-5, etc.).
- Engineering Studies
- Spreadsheet Validation (GAMP-5, 21 CFR Part 11, etc.).
- Sterilization Process Validation (AAMI, ANSI, ISO, 21CFR, etc.)