• CaliberBRM

Addressing the Manual Maintenance of Logbooks Issue

A leading global pharmaceutical company with multiple plants and departments and with a good foothold in contract manufacturing products was facing a problem with the paperwork. There was no traceability and efficiency in all inventory, operation, cleaning, usage, and maintenance of instruments/equipment and areas. The details were manually entered in a pre-defined format logbook.

Challenges:

1. Maintained manual logbooks for individual areas/equipment.

2. Very difficult to maintain the printed logbooks of the same format for individual areas and equipment.

3. No Tracking on the usage of area/equipment by the right person.

4. Back entry activities (also known as activities performed in real-time) did not match with the entry time.

5. Sometimes delay in reviews and approval occurs in a hurry for the document

6. No control on the format/annexure’s modification.

7. No control over the parallel entry transactions.

8. No restriction on equipment when maintenance activity was overdue.

9. No tracking on the modified fields whether it is old entry or a new entry.

10. Hard to retrieve the data of past years.

11. All the fields entered by the users in regional languages; therefore, the product details and the batch details were not understandable. (Handwritten)

12. No control over the performed transactions (Area/Equipment). Further, no tracking of the approver’s wrongly approved transaction too.

13. No tracking on the current status of equipment/area.

14. No tracking on current usage transactions of area/equipment.

15. No control over centrally harmonized formats/annexures.

16. No restriction on cleaning activates immediately after usage transactions.

17. No restriction on equipment/Area usage logbooks for other department users.

18. No tracking on the master’s modification/status change.

19. Very hard to remember the product/material names and enter in the logbook.

20. No control over the fields (product/batch/stage etc..) entry, i.e. though the field entry system was skipped, the process could proceed further.

21. Task review assigned to a department user was either time-consuming or pending for a longer duration of time.

Solution

Implemented CalibereLog after a thorough requirement study of all the GMP document management.

1. Implemented basic version for the single plant-available – Plant1.

2. All the Logbooks at the plant were completely automated and centrally harmonized for entry to approval and final reports.

Critical processes automated:

1. Automation of all department logbooks.

2. All the handwritten fields are automatic.

3. A right person with the login access credentials tracks all the transactions of area/equipment.

4. All the back-entry operations are not allowed, and if someone indulges in it, they are tracked with the audit trails option.

5. Restricts all the parallel entry operations.

6. Control on master’s modification with proper high-level approval.

7. Automates all the non-operational activities like cleaning/PM/calibration with scheduled maintenance plans.

8. The system is SAP-integrated and thus, all the data (Masters) will be automatically pulled from the SAP system.

9. All the usage/master modification will be version controlled.

10. In one report, we can retrieve the data of all the equipment/areas where we can apply the filters of past years in no time.

11. Automates all the checklists.

12. Facilitates running of the checklist parallelly with area and equipment as all the checklists are bonded with area and equipment usage.

Benefits

1. Complete automation of formats/annexures preparation and track of usage transaction of reports.

2. Reduction of manual logbooks.

3. Easily provide the equipment/area access through masters.

4. Reports facilitate faster business decisions that can lead to good business profits.

5. Extensive equipment data which can be used across for several products

6. Provide desired configuration reports effortlessly.