Validation and GxP Compliance.
Validation and GxP Compliance.
The challenge of "validatability"
The main challenge for the validation department is ensuring that the design intent is "validatable", meaning the specified systems and equipment can be proven to meet stringent user requirements and regulatory standards (like cGMP). This requires early and deep engagement to review and approve critical design documents (like URS, FDS, and P&IDs) and establish the Design Qualification (DQ). The validation team must challenge the design upfront to prevent costly and time-consuming rework during the later Commissioning, Qualification, and Validation (CQV) stages.
An integrated bridge to regulatory approval
Equans Sci-Tech ' Validation department is in-house and fully integrated into the design team from the concept stage. This single-point-of-contact approach is essential for ensuring projects meet both quality standards and regulatory requirements set by authorities such as the MHRA, ICH, FDA, and EMA.
Our integrated team eliminates the significant risk of misinterpretation, scope gaps, and interface conflicts often introduced by external validation teams. The Validation Manager acts as a vital bridge between Quality Assurance, Engineering, Production, and Regulatory Affairs to ensure seamless compliance.
We provide the comprehensive framework required to secure regulatory confidence and ensure the project is ready for the "Deliver" phase and have stand-alone services as well
- User Requirement Specification (URS)A definitive document capturing all functional, operational, and regulatory mandates to ensure the system is fit for its intended use from the outset.
- System Impact Assessment (SIA)A risk-based evaluation used to categorise systems as 'Direct', 'Indirect', or 'No Impact', ensuring validation efforts are focused where they matter most for product quality and patient safety.
- Design Qualification (DQ)Formal, documented verification that the proposed design—including facility layouts and technical specifications—is compliant with GMP and fully aligns with the URS prior to procurement or construction.
- Requirements Traceability Matrix (RTM)A comprehensive tracking tool that maps every requirement from the URS through to its corresponding design element and final test script, ensuring no critical feature is overlooked.
Find the answers to your questions
DQ is a crucial step in the validation lifecycle. It proves that your design meets the User Requirement Specification (URS) and GxP standards before you commit to construction, preventing expensive modifications later.
We manage risk through a rigorous Design Qualification (DQ) process, underpinned by a Requirements Traceability Matrix (RTM). By mapping every technical requirement back to the initial design at this early stage, we ensure that critical system failures are 'engineered out' before construction begins. This traceability ensures that every design decision is documented, verified, and aligned with your operational and regulatory goals.
Yes. Our team is expert in MHRA (UK), FDA (US), and EMA (Europe) requirements, ensuring your facility is capable of global market access.
Most contractors wait until the build is finished to involve validation, but we believe that compliance must be "designed in." Our in-house experts collaborate with the design team from day one to perform a Design Qualification (DQ). This ensures that the architectural and MEP plans are fully capable of meeting your User Requirement Specifications (URS) before a single brick is laid, preventing costly remedial works during the final commissioning stage.
Our validation specialists take ownership of the RTM as soon as the project begins. They map every regulatory and operational requirement to specific design elements. Because this expertise is in-house, there is a continuous "feedback loop" between our engineers and validation experts. This ensures that any design changes are immediately assessed for their impact on the final Project Validation Plan (PVP), maintaining a "Golden Thread" of compliance throughout the project lifecycle.
Let's define, design and deliver the future together
Let's define, design and deliver the future together
