Electronic laboratory notebook regulations

Scientific Workspaces are a specialized concept of electronic laboratory notebook software underlying less restrictive regulations than electronic scientific documents. They are containers designed for personal preparation of data as well as for effective organization, sharing, and publishing of information within a team. 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

The current good manufacturing practices (GMP) state that Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards [5]. This includes all electronic and hard copies of raw data, laboratory notebooks, and/or worksheets and reports. Additionally, the regulations require that records shall be readily available for authorized inspection [6]. Consequently, the organization must have a well-defined audit trail for the generation, storage, and retrieval of reports and raw data. It must also be shown that there is adequate document management and security of all raw data and reports in terms of both disaster recovery and prevention of falsification of results. 

The discipline of the regulated laboratory requires the equivalent of a notebook or log, physical or electronic, that will record problems. The recording by itself, however, is not sufficient evidence of control. The tracking and resolution of these problems both demonstrate that active measures are... 

---