OR WAIT null SECS
November 01, 2002
The security of documents in the pharmaceutical industry has become a critical issue since the advent of electronic data transfer. Companies in Europe must comply with 21 CFR Part 11 if they sell in the US. The regulations also require that secure, computer-generated, time-stamped audit trails are used to record the date and time of operator entries and actions that create, modify or delete electronic records. In particular, the record change must not obscure previously recorded information.
October 02, 2002
The European Union is attempting to reform its current business environment in hopes of restoring its role in the lobal R&D sector.
October 01, 2002
The benefits of using computers and electronic records are proven in most fields of modern-day work, none more so than in laboratories. The opportunities for automation have improved productivity; the computational abilities have increased the accuracy of scientific data and allowed previously difficult or impossible analytical techniques to become routine affairs. This, in turn, has led to huge advances in drug discovery and in the chemical, biochemical and physical analysis of drugs and patients.
A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.
September 02, 2002
When choosing a CRO, take the time to conduct an in-depth evaluation of each department, paying special attention to the quality and training of its personnel.
July 01, 2002
Following a step-by-step approach to software development involves planning, analysis, construction, and implementation.
July 01, 2001
Appropriate sampling procedures, proper preparation, and correct instrumental parameters may yield differing, but correct, results.
June 02, 2001
Special considerations and cautions must be adhered to when designing virus safety studies and developing appropriate virus contamination control programs.