LabsForm - Assets and Form Completions

LabsForm software enables secure forms to be generated that accept laboratory data input via PCs and/or laptops / handhelds. The forms 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. LabsForm also includes a scheduling option for routine procedures such as equipment qualification and study related timelines.

The bioanalytical package (Labnotes) offers an "out of the box" solution with fully configurable forms to comply with the requirements of regulated analytical groups (GxP environments). It incorporates a suite of fully validated standard forms and templates suitable for immediate installation. 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.

LabsForm 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. Click on image to enlarge.