Labnotes™ as a Free-Form Notebook:

The sophisticated ELN environment enables users to cut and paste data, graphics and hyperlinks from any other windows based software. This includes, but is not limited to; spectra, chromatograms, structures, pictures, text, etc which are all stored in the secure Oracle database. Documents from Microsoft applications are embedded within the software and are saved in the secure Oracle database. These are fully version controlled and can be launched, viewed and edited within the Labnotes window. All data including the contents of embedded documents are catalogued and stored in a secure database and can be searched using an advanced search engine. This environment also enables the user to input narrative associated with the data; all entries are date stamped automatically with the user ID, key words and any project identifiers required. All security associated with the forms area of Labnotes is incorporated into the ELN environment.

Labnotes™ With Templates:

The application enables secure forms to be generated that accept laboratory data input via PCs and/or laptops / handhelds, and it can be directly linked to electronic devices such as laboratory balances, pH meters, etc. Networked or wireless communications are accommodated for by the package which allows data to be interrogated, tabulated, checked, approved, stored and archived to comply with the latest regulatory guidance and legislation. Labnotes also includes a scheduling option for routine procedures such as equipment qualification and study related timelines.

The package offers a high level of flexibility to users, incorporating a suite of tried and tested (in a GxP environment) standard forms suitable for immediate installation and use, and allows users to configure forms quickly and easily to suit particular in-house requirements. An added benefit is that the package offers full document version control and revision management control, thereby allowing the expeditious sign off of new systems and of data by all relevant parties.

Security is built-in with electronic signatures required for all data acceptance, and all entries and amendments are fully audit trailed. Access can be configured to user requirements on a study-by-study basis in line with the requirements of 21 CFR Part 11, resulting in improvements to data confidentiality and limiting access to commercially sensitive information.

Labnotes dramatically reduces time required to check and correct data, as entry errors or omissions are automatically highlighted at the data entry stage. Calculations are performed automatically with accuracy guaranteed as pre-validated formulae are built into form templates where applicable. In addition, equipment out of calibration cannot be selected for use without users being required to enter a reason. Forms can be locked automatically at appropriate stages, preventing any further alterations to data without appropriate authorisation.

Labnotes is an "out of the box" solution that as standard has fully configurable forms to comply with the requirements of regulated analytical groups through to a sophisticated electronic laboratory notebook (ELN) for inclusion of structures, spectra, chromatograms, pictures, text, etc where a preconfigured form is less appropriate. All data within Labnotes is stored in an Oracle database and is therefore fully searchable. The unique flexibility of Labnotes means that data can be collected, stored and retrieved through any combination of forms and/or ELN that best meets the requirements of the user.