2024年10月30日 · Learn why a User Requirements Specification (URS) is essential in CQV. Discover how it defines project goals, enhances compliance, and streamlines vendor processes for successful system validation.

At the heart of our mission lies a commitment to delivering exceptional commissioning, qualification, and validation (CQV) services to traditional and biotech pharmaceutical clients. With a foundation built on experience, passion, and unwavering quality. We strive to provide best-in-class solutions that meet the unique needs of our clients.

Two major pieces to solving this puzzle are identifying and approving critical user requirement specifications (URSs) early in the project and the effective use of Requirements Traceability Matrices (RTMs). The URS (sometimes called a Process or Product Requirements Specification) will be the basis for all equipment & system testing.

2024年11月9日 · The User Requirements Specification (URS) is a key document in the commissioning and qualification (C&Q) process, setting out the essential requirements a system must fulfil to be suitable for its intended function. It defines quality, process, and regulatory criteria based on the product’s critical attributes and process parameters, though ...

CQV (Commissioning, Qualification, and Validation) is a very detail-oriented process that requires the right mix of knowledge, experience, and diligence to correctly place equipment/systems into use. Additionally, with FDA regulations and requirements continually changing, it is crucial to understand the CQV process to remain compliant.

2024年9月17日 · The User Requirement Specification (URS) is foundational for any CQV project. It outlines the system’s intended function and operational requirements, including aspects critical to product quality and patient safety. Incomplete or unclear URS documentation leads to design flaws, validation gaps, and ultimately project delays. Common Issues:

NNIT的CQV团队由一群经验丰富的测试顾问构成，他们平均从业年限超过8年。 团队采用基于风险的确认方法，以GEP（良好工程实践）指南为基础方法论，为客户提供高质量的CQV项目文档，赢得客户的广泛认可，有效减少合规风险。

2024年11月6日 · In this article, we’ll explore the phases of the V Model in detail, covering each stage from User Requirements Specification (URS) to Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and the critical qualification stages. Pharmaceutical companies rely on the V Model for compliance.

2023年10月26日 · The first phase of a comprehensive CQV effort is to finalize the required User Requirement Specifications (URS), and Risk Assessments (RA). Quality Risk Assessments by Subject-Matter-Experts (SMEs) in the process at hand provide risk control strategies and the necessary engineering controls.

2024年12月12日 · Documentation is the backbone of CQV, serving as evidence of compliance during audits. Essential documents include: User Requirement Specifications (URS): Define the intended purpose of equipment or systems. Test Protocols and Reports: Detail procedures and results for IQ, OQ, and PQ.