Computer System Validation
Mastering Compliance , Ensuring Integrity and Efficiency through Reliable CSV Solutions
Mastering Compliance , Ensuring Integrity and Efficiency through Reliable CSV Solutions
We validate by examination and provision of objective evidence that software parameters align with user needs and intended uses, and that specific requirements implemented through software can be consistently fulfilled.
At Zenovel, we uses the GAMP 5 “V-Model” to ensure the safety, accuracy, and quality of computerized systems used in GxP activities, including production, raw material receipt, storage, dispensing, exporting, and quality control. This risk-based methodology includes IT infrastructure verification, routine reviews, system shutdown, planning, specifications, setup, verification, and reporting.
We apply audit trials and clear, unambiguous documentation to demonstrate compliance with Annex 11, and 21 CFR Part 11.
Our procedure prioritizes data integrity, accuracy, dependability, and consistency, ensuring clients receive reliable and trustworthy results.
We offer customized delivery options through the use of offshore, remote, and onsite resources.
The European Union’s Good Manufacturing Practice (GMP) standards, as outlined in the Annex to the Guide to Good Manufacturing Practice for Medicinal Products, ensure the quality and safety of medicinal products, including those used in clinical trials. The Qualified Person (QP) plays a crucial role in batch certification, particularly for
In the intricate process of developing new pharmaceuticals, guaranteeing product safety, effectiveness, and adherence to global regulations is essential. Batch release testing acts as a pivotal quality assurance measure, confirming that medications comply with rigorous criteria before distribution. When combined with International Council for Harmonisation (ICH) standards, this testing framework
In the world of life sciences, quality isn’t just a benchmark—it’s the backbone of success. Three key pillars—Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP)—form the core framework that supports everything from product development to regulatory approval. These standards aren’t just industry buzzwords; they’re the
In the pharmaceutical industry, quality is paramount—and at Zenovel, we are deeply committed to delivering excellence in Quality Assurance (QA). Our focus is on ensuring that every medicine is developed, manufactured, and delivered with safety and reliability as top priorities. QA is embedded in every stage of the pharmaceutical lifecycle—from
The U.S. Food and Drug Administration (FDA) emphasize the importance of data integrity in pharmaceutical manufacturing, particularly under its Current Good Manufacturing Practices (CGMP) rules. However, issues like fake lab results and sloppy record-keeping persist, posing risks to patients and losing confidence in the system. Independent oversight is crucial to
In the rapidly evolving pharmaceutical industry, assuring product quality and customer safety is a need. This endeavour continues to be based on validation, a methodical procedure to verify that manufacturing procedures and equipment consistently deliver high-quality outcomes. A strong strategy to validation is required in 2025 due to the complexity
