Logbook maintenance for every process is becoming huge and time consuming task for Pharma companies nowadays. Use of Excel logbooks, printing, documentation and continuous track are tedious and resource occupied tasks.

It is utmost required to have a process/software wherein eLogbook can be configured which is part 11 compliant (21 CFR and Annex 11).

QEdge QMS (Quality Management System) offers an excellent platform for implementation of eLogbook which helps users to improve productivity, compliance, reduce 100% paper work.

If we have comparison between manual logbook v/s. electronic logbook;

Manual Logbook eLogbook
Availability
  • Manual logbooks are scattered throughout the facility and difficult to access
  • Data in web based electronic logbook are captured on central database and there is easy access of the data
Accuracy & Compliance
  • No control access of logbook
  • Unauthorized data modification
  • No proof of real time data entry
  • Compliance check of logbook against other data is a curse
  • Manual entry legibility is issue in terms of GDP and deterioration of paper with time
  • A curse of finding the history of details and versioning of the log formats
  • Manual approval and delays in case of unavailability
  • eLogbooks have fully controlled access and all the data have time stamped audit trail
  • Easy compliance checks due to multiple filters
  • Computerized entries are systematic across all operators and auto backed up data is always available with same quality as part of legibility
  • Most of the compliance is taken care by the system by various alerts and inbuilt security commands
  • It is easy to track any record at a given point of time and entire format history shall be maintained
  • Approval process can be done quickly for all the records in a single click
Productivity
  • Manual maintenance of instrument records like calibration, qualification, etc.
  • Printing & binding of logs

 

  • System maintains the data of all the instrument related information which provides critical alerts to the users at time of data entry
  • This decreases duplication of work, No need to print anything as all are there in the system itself