BioPharm International-03-15-2002

by Mary Jo Veverka Accenture Significant amounts of time and effort are spent on validating computer systems. Companies that want efficient, high-quality systems can avoid considerable consts by incorporating CSV capabilities throughout systems development.

by Archie Lovatt, Donna McMutrie, John Black, and Iain Doherty Q-One Biotech Ltd. Real-time quantitative PCR has revolutionized the detection and quantification of viral contaminants. Quantitative PCR assays can detect noncytopathic viruses that have recently become a concern in testing for biopharmaceutical safety. High versatility reproducibility, and throughput of such assays decrease the time spent in development, testing, and regulatory compliance.

by Christopher L. Gent Pharmacia Corporation Validation is required for computer systems used to create, modify, maintain, archive, retrieve, or transmit data intended for submission. To ensure that the QA/QC and the IT departments speak the same language, a system developer will build documented evidence that a system's functionality has been tested, performs as specified, and generates reproducible results.

by Robert Zeid TLI Development The corporate fantasy where everyone knows all the systems all too often collides with a nightmare reality where all the systems are known by only a few. Any specification or manufacturing change that affects various departments can quickly become a bewildering morass of proposed, actual, and implemented changes ? with few connections to actual lots and practices. Draw a line in the CMC "sand" where those changes actually began.