The right balance of automated processes with paper records and manual, human interaction is necessary to keep costs under control with a flexible yet controlled set of procedures. The strategic software category, governance, risk management, and compliance, is poised to help.
paper by Olin Thompson, FDA Compliance for the Life Sciences ). In any organization, evaluation of the characteristics of operations, products, and so forth will reveal the mix of standard versus exceptional circumstances. The most effective procedures will allow computer systems to assist in repetitive operations. At the same time, computers can integrate manual or semi-manual approaches to exceptions, which should be captured in a digital form to facilitate the storing and retrieving of documents,