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How Logilab SDMS helps Laboratories to enable GLP Compliance – Part 4

GLP Principles During Operational Phase of Logilab SDMS

Accuracy checks

GLP lays down a very important principle that the data captured or entered in the system must be accurate. In order to ensure accuracy, GLP necessitates computerized system must have the capability to validate, verify and filter the data for accuracy. Logilab SDMS ensures that users can verify the data that is captured from the instruments can go through a workflow process. Using the workflow tool users will be guided to follow the review and
approval processes so that data errors can be avoided. Logilab SDMS also supports electronic signature. Authorised users can place electronic signatures on appropriate records with the username, password and the reason with a date
and time stamp is recorded. This will ensure that users can be fixed with the responsibility to carry out necessary checks during the data transaction process. Scheduling certain type of files generated in Lab process using file type watcher. This will ensure filtering out of unwanted data or files. Users can identify or provide additional metadata for instrument generated data by entering batch numbers, sample types, projects, sample ids. Whatever metadata that is suitable for the instrument data, it can be tagged in meaningful names. This improves the accuracy of the data. The instrument data can be searched easily using the specific tag name.

Data Storage and Access

GLP requires that electronic data capture, storage, backup and retrieval must not violate data integrity principle. Easy accessibility, readability, restorability, security, accuracy must be ensured for data/records in a continuous manner. The core functionality of Logilab SDMS is Scheduler. The Scheduler can capture data generated by instruments automatically. It can be configured with respect to time. Livecapture module is used as and when data is generated being used by any other software.

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