A leading company, our client, with a decent yearly turnover and huge production of injectables and viols products with multiple sites and departments is facing a problem with the documentation of preparation and review approvals.
1. Document review work delayed due to time taken by the department user for the review.
2. With this, the respective document preparation process got delayed and sometimes in a hurry document was approved and made effective for the completion of activity.
3. All the approved documents were distributed to the other departments for training purpose by taking the Xerox of no. of copies and stamping on each page as “For Training.”
4. Soon after the completion of training, the document was made effective and controlled copies were distributed manually.
5. During the issuance of documents like SOPs and formats, a separate issuance log had to be maintained for each document type and for the frequently used formats. Also, the CQA formats were to be transferred to other plants for the usage.
6. In case of SOP issuance, an additional logbook for the retrieval of the previous SOP had to be maintained.
7. In some cases, issuance details were not updated in the log book by the user and document was issued to other depts. Due to such an issue, the document tracking for the retrieval became a daunting task.
8. As per 21 CFR Part 11, the document retrieved had to be destroyed by QA personnel so that the production or procurement people would use only the updated SOP and follow updated process as per SOP.
9. Due to the large supply chain, time consuming procedures involved to reach the end point, and availability of the updated SOP’s, quality management of the production faced major challenges.
CaliberDMS was implemented after a thorough requirement study for all the GMP document management.
1. Implemented basic version for the single plant available – Plant1.
2. Documentation at the available plant locations is completely automated for monitoring from document preparation to issuance and retrieval.
Critical processes were automated:
1. The issuance and retrieval tracking of documents can be updated along with the system for the tracking.
2. Issuance details like Issuance Code, Issued By, Issued On can be printed on each 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.
3. Retrieval of the document and complete tracking till destruction of the document is automated.
4. Automatic Log Updation for issuance, retrieval and destruction to check tracking of any document in the system.
5. Necessary alerts are sent through email on approval, rejection, print of the document.
6. Facility for viewing print log, issuance log, active documents, obsolete document reports by all users.
7. Access through internet/intranet.
8. On-line Knowledge base, Manuals and Procedures.
1. Better tracking of the documents under issued, retrieved and destroyed categories.
2. Complete automation of documentation process helps in reducing time and effort.
3. Reduction of Logbook and other paperwork.
4. Reduction in data integrity issues and Increase in confidence on quality of documentation and distribution of documents.
5. Complete documentation of all the processes till the end point.
6. Reduced cost of documentation with respect to unnecessary printing and cost of manpower with respect to document distribution, etc.