The client, a leading company involved in huge production of contract manufacturing products with a single plant and multiple departments, was facing problem with the documentation of preparation and review approvals.
1. All GMP documents were prepared manually and a draft copy was circulated for the other departments’ review.
2. Documents were not properly reviewed by other departments due to other important activities in the plant.
3. Critical cases like signoff completion without proper review of the document was common leading to confusions.
4. The reviewer comments or suggested changes on the documents may not be guaranteed with the document updation after review.
5. The fields in the document like previous effective date, distributary departments, effective date columns along with the signatures of review and approvals were written manually.
6. 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.”
7. Soon after the completion of training, the document was made effective and the controlled copies were distributed manually.
8. 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 suffered challenges.
9. Monitoring at every stage with respect to each plant had become herculean task and time consumption for QA personnel.
From Plant QA — Department Head — Employees
10. Delay in retrieval of 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 of all the GMP document management.
1. Implemented basic version for the single plant available – Plant1.
2. Documentation at the available plant location is completely automated for monitoring from document preparation to issuance and retrieval.
Critical processes were automated:
1. Online document preparation with review comments option as a sticky note’s functionality for comments is available.
2. The document review process with respect to each comment given by the reviewers is valuable for the initiator and the initiator can provide the response by accepting or rejecting the change suggested.
3. The tedious work of printing of documents is being reduced for the training of the SOP as the view of approved SOP is available and can be trained with the system.
4. The review approval workflow is automated so that soon after the completion of one approval, the document will be available for the next reviewing person.
5. Document preparation status, review approval status, publish status, print status, reprint status can be known by checking the system directly.
6. Necessary alerts through email on approval, rejection, print of the document is provided.
7. Facility for viewing print log, issuance log, active documents, obsolete document reports by all users is available.
8. Access available through internet / intranet
9. On-line knowledge base, manuals and procedures are available.
1. Getting rid of document transport process for the reviewer approval signatures over the document.
2. Complete automation of document preparation and track of document issuance to destruction.
3. Reduction of logbook for issuance of documents and formats.
4. Increased confidence on quality of documentation and distribution of documents to avoid data integrity with all the facilities.
5. Complete documentation to last point monitoring and making effective usage of the documents.
6. Reduced cost of documentation with respect to unnecessary printing and cost of manpower with respect to document distribution, printing the issuance numbers for the tracking purpose.