Interpreting Guidelines for Efficient Compliance
With the update of GAMP5, Wellthinic places great emphasis on continuous learning. The validation and quality teams actively participate in ISPE’s technical discussions to stay aligned with regulatory updates. We understand that only by closely tracking policy changes and advancing validation methodologies can we deliver high-quality, compliant CSV services—ensuring data integrity and meeting regulatory requirements for our clients.
Internationally Recognized Certification
The ISPE certification, awarded by the International Society for Pharmaceutical Engineering (ISPE), is a globally respected credential in the pharmaceutical industry. ISPE drives innovation and technological advancements in pharmaceutical manufacturing while supporting China's pharmaceutical sector in aligning with international standards. The certification is widely recognized as a mark of expertise in compliance, validation, and cutting-edge pharmaceutical engineering practices.
Data integrity is critically important in the pharmaceutical and life sciences sectors. This training will focus on key regulations, including 21 CFR Part 11, along with methods to meet international regulatory requirements for electronic records and signatures.
The importance of data integrity in systems and the data lifecycle, inspection methods, as well as data governance frameworks, maturity models, mapping tools, and the application of quality risk management.
Data lifecycle integrity, regulatory requirements across different jurisdictions, data governance, GxP-compliant system operations, and the impact of spreadsheets, mobile devices, and cloud computing on data integrity.
In the pharmaceutical and life sciences industries, every production step is critical to product safety and compliance, making stringent validation capabilities essential. With decades of pharmaceutical validation experience and a global perspective, Wellthinic provides comprehensive CSV services that cover all aspects of computerized systems—from requirement analysis and design verification to installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)—all rigorously executed in compliance with regulatory standards. With Wellthinic's support, pharmaceutical companies can focus more on drug development and manufacturing, delivering safer and more effective products and services.
