Our client, a leading global pharmaceutical company which has good foothold in contract manufacturing products with single plant having multiple departments, is facing a problem with the documentation process. Issues cropped up during manual preparation and review approvals of documents.
• The documents which were applicable to one departments were sent on requisition of the other departments and there was no control of the distribution as part of the applicability.
• To have the track of distribution, the applicable distributary departments had to be maintained somewhere in the logbook or mentioned on the document.
• Other than the initial distribution of the documents, the additional documents were requested by the user and issued by QA personnel outside the system.
• During distribution of documents, the previous version of the document was being retrieved for destruction manually by recording the same in logbook where the issuance entry had to be searched manually.
• With this, the respective document distribution got delayed and sometimes in a hurry the document was distributed without the retrieval of old version of the document for the completion of activity which is not a good practice as per 21 CFR Part 11 regulations.
• Monitoring at every stage with respect to each plant had become huge task and time consuming for QA personnel.
From Plant QAOther Department HeadEmployees
• Delay in bringing the approved documents, data integrity in issuance into effect led to increase in communication cost, resources and time consumption.
CaliberDMS was implemented after a thorough requirement study for all the GMP document management.
• Implemented basic version for the single plant available – Plant1.
• Documentation at the available plant locations is completely automated for monitoring from document preparation to issuance and retrieval.
Critical processes were automated:
• With the concept of auto-distribution, all the required no. of copies can be selected to have the limited no of copies distributed to other departments.
• During the preparation of documents, the initiator can select the other departments applicable for the document so that the limited number of copies of the document can be provided to the other departments.
• Further requisition of documents can be raised in the system and get approved for the document copy print from the system. Soon after the print of the document, the issuance details can be updated in Document Movement.
• The issuance and retrieval tracking of documents can be updated along with the system for the tracking.
• Issuance details like Issuance Code, Issued By, Issued On can be printed on each and every page of the document. Along with the issuance of the document, the entry of issuance can be entered in the system by requesting the acknowledgement of receipt of the document on the other end.
• Retrieval of the document and complete tracking till destruction of the document is automated.
• Automatic Log Updation for issuance, retrieval and destruction to check tracking of any document in the system.
• Necessary alerts through email on approval, rejection, print of the document.
• Facility for viewing print log, issuance log, active documents, obsolete document reports by all users.
• Access is available through internet/intranet.
• On-line Knowledge base, Manuals and Procedures are made available.
• Auto-distribution is achieved within the departments available with the system which reduces the time consumption for distribution of document.
• Better tracking of the documents under issued, retrieved and destroyed categories.
• Complete automation of document preparation and track of document issuance to destruction.
• Reduction of logbook for issuance of documents and formats.
• Increased confidence on quality of documentation and distribution of documents to avoid data integrity with all the facilities.
• Complete documentation to last point monitoring and making effective usage of the documents.
• Reduced cost of documentation with respect to unnecessary printing and cost of manpower with respect to document distribution, printing the issuance numbers for tracking purpose.