SmartLogBook was developed as a „tailor made“ solution to meet the requirements of the pharma industry and chemical laboratories. The entry of records is possible using a web client or an iOS App being available for iPhone and iPad at this time. This client server solution can be implemented as a cloud based solution as well as in-house hosted service. (An Android App is currently under development).
The data is stored in a referenced file structure and does not necessarily require the implementation of a database. However it will be possible to use databases as storage for log book entries in a further stage of development.
During development, the focus was to fulfill the high requirements in respect of data integrity and security, being obligatory for the pharma and chemical industry. To allow workflows with dedicated functions of the persons involved, users are grouped as „SystemOwner“, „Approver“, „Reviewer“ and „Author“. Using Microsoft Active Directory authentication is possible as well as local user authentication.
The numbers of Log Books being handled by a SmartLogBook Server is just limited by the available hard disk space storing the log book related entries. The store is organized by objects with related elements to handle the information for each system element. Attachments like documents and pictures can be assigned to each log book entry individually.
By defining workflows (modes) it is possible to address special requirements and different situations requiring documentation in the log book. By default the following modes are available:
Generate an entry and sign by e-signature (Username/ Password)
Generate an entry and sign by e-signature (Username/ Password). The entry is routed automatically to a quality related person for approval by e-signature.
Generate an entry and sign by e-signature (Username/ Password).
X-check by another person is required (System Owner / Quality) to approve this entry. This is intended to allow pre-approval of activities to be documented in the log book together with the documentation of the respective activity after being performed. Additional approval by responsible function (System Owner / Quality) is required to close the workflow of this mode.
e-Mail notifications can be implemented to ensure notification of approvers to make them aware of Smart Log Book entries awaiting approval.
On devices featured with a camera (tablet, smart phones, iPad/iPhone) QR-Code scan functionality can be used to ensure that entries are assigned to the correct system. Scanning the code located on the devices will automatically activate the proper log book and allow immediate documentation accordingly.
Smart Log Book creation is only possible using the web interface of Smart Log Book and requires membership of the Smart Log Book Administration group.
To support the handling during daily use the general design of the Smart Log Book user interface is intentionally very simple and reduced to the required elements.
The following languages are currently implemented in Smart Log Book user interface: German, English, Spanish, Italian, French, Russian und Croatian.
It is possible to switch between these languages dynamically any time.
We are happy to offer the total package of validation including the test script generation according to customer requests and also data integrity related consulting and evaluation support.
We are happy to demonstrate the functionality of Smart Log Book in an online presentation!
Please contact us for an appointment!