CSV is an essential part of quality assurance in the pharmaceutical and related industries, as stipulated in GMP appendices. The Wellthinic Technology validation team has extensive experience in the pharmaceutical industry and validation consulting. They have provided validation services to numerous domestic foreign-invested and state-owned pharmaceutical companies, as well as software developers. The team is highly familiar with computer system validation and possesses GAMP5 validation capabilities, with a deep understanding and extensive practical experience of both domestic and international GMP regulations.
Providing GMP and FDA compliant computerization compliance services to meet the requirements for GMP computerized system validation to reduce risks.
【Provide computerized system validation based on the GAMP5 Guide, Second Edition, ensuring that the validation plan is up-to-date. Conduct compliance reviews in accordance with regulatory requirements to ensure data integrity.】
Product Key Advantages:
Implemented numerous projects for well-known domestic and international clients, providing a complete set of system validation documents.
Based on the GAMP5 Guide, Second Edition, we provide computerized system validation to ensure that the validation plan is up-to-date. Compliance reviews are conducted in accordance with regulatory requirements to guarantee data integrity.
The iterative CSV validation model has replaced the linear model, allowing for an increase or decrease in the validation process based on the complexity of the system, making the validation work more efficient.
The system debugging and validation processes focus more on the completeness of functional implementation and data compliance. Designing to eliminate system risks is the optimal choice, but system risk levels can also be reduced through the debugging and validation processes in response to the results of system risk assessments.
Product Benefits：
The integrated C&O method applies the validation flowchart of the lifecycle approach from ASTM E2500, "Guideline for Specification, Design, and Qualification Standard for Pharmaceutical/Biopharmaceutical Production Systems and Equipment," breaking it down into implementable specific processes.
Strictly based on the results of the system's risk assessment customize the CSV validation strategy and content.
Having a mature project management system and a professional CSV engineering team, offering customized validation solutions.
Our team has a background in the pharmaceutical industry, extensive experience, and a deep understanding of GxP regulations. With profound expertise in CSV validation within the GxP domain, we accurately assess risks associated with various systemsand ensure minimal impact on clients' existing operations and maximize project execution efficiency.
