Labsform, a new software application for routine data recording in the laboratory has recently been launched by Laboratory Data Solutions.
Labsform, a new software application for routine data recording in the laboratory has recently been launched by Laboratory Data Solutions.
Labsform has been designed to operate alongside existing LIMS, filling an important gap in electronic data recording and management.
The product provides users with the freedom to convert existing paper-based recording systems into electronic templates.
Labsform has been developed not only to streamline laboratory operations, but also to facilitate compliance with the FDA's guidance on electronic record keeping cited in 21 CFR Part 11.
Labsform has been produced by Terrington Systems Limited, a world leader in secure software systems, in conjunction with highly experienced laboratory scientists from York Bioanalytical Solutions, the UK's premier independent bioanalytical specialists.
The application enables secure forms to be generated that accept laboratory data input via PCs and/or laptops, and it can be directly linked to electronic devices such as laboratory balances.
The package then 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 package offers a high level of flexibility to users, incorporating a suite of tried and tested standard forms suitable for immediate installation and use, and allows users to configure forms quickly and easily to suit particular in-house requirements.
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 can deliver extensive improvements in laboratory efficiency, reducing time spent checking and correcting data entry errors or omissions which are automatically highlighted at the data entry stage.
Calculations are performed automatically with accuracy guaranteed as prevalidated formulae can be built into form templates.
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.
