Study Interface was developed to record, manage and collate study data in regulated, bioanalytical laboratories. Study Interface simplifies the creation and use of analytical methods and study data, whilst ensuring full control of the method and study design processes. Study data is stored in a central database in which each study is an ‘App’. Analysts can be given access to each study on a per App basis. The Interface can be used alongside Terrington’s LabsForm (and Labnotes) software products.

CREATE ANALYTICAL METHODS - Create an analytical method in minutes by selecting of one of a range of pre-configured templates for the required assay/study. The method templates (SOPs) contain all the individual forms (POIs) associated with the method. Methods are divided into sections, which enables checking and approval as each section is completed.

CREATE A STUDY - Creating a study is a very simple process. The study director assigns an approved analytical method to a new study and then assigns users and user groups.

STUDY DATA - Once a new study has been created, the Study Menu becomes active. This menu is broken down into the following areas:

Analytical Standards and Stock Solutions.
Calibration Standards/Quality Control Samples.
Matrix Effects/Recovery/Stability.
Analytical Runs.
Miscellaneous.
Reagent Preparation.
Ancillary Data.

To complete a process (data entry) all you need to do is select the relevant section from the menu and the fill in the form. Linking the assets (methods) to the form reduces transcription error as method protocols automatically populate the relevant fields. In the example below the information in the green fields is linked to the method asset.

APPROVAL OF DATA - Simple review screens are available which show the status of all data approval. A summary of the number of form completions (procedures performed), together with the number already approved allows the Study Director to clearly see the current review status for the study.