Electronic Document Management Software Case Study-Pharma casestudy
Customer, one of the largest specialty generic pharmaceutical companies in the world. Based in India, they have API and finished formulation production facilities while providing high-quality, affordable medicines trusted by healthcare professionals and patients in over 100 countries globally. Customer is establishing collaborations including in/out-licensing of products and technologies, strategic alliances, joint ventures, and mergers and acquisitions as they strengthen their presence in other markets across the world.
Customer is a pharmaceutical manufacturing company and has to deal with a lot of paper documents as well as to create, record, track and store thousands of documents every year and this resulted in the company having to file large amounts of paper documents and records locally in its main office premises or store its paper based documents in filing cabinets and in an archive which made searching for each document extremely difficult.
Major challenges with a legacy approach to document management process include:-
- Departments had multiple copies of paperwork so employees were having to spend a lot of time in copying and filing documents.
- Filing cabinets were located throughout the company were not always accessible to everyone making responding any queries is time consuming and inefficient. Paperwork also took up a large amount of office space.
- There was no way to easily identify changes made in different versions of the documents, thus additional time was required to identify changes as well as revision date of SOPs.
- During the issuance of documents like SOPs and formats, a separate issuance log had to be maintained for each document type and for used formats.
- The reviewer comments or suggested changes on the documents may not be guaranteed with the document updation after review.
- All the approved documents were distributed to the various departments manually by taking the print outs of copies and stamping on all pages as “controlled or uncontrolled copies”
- Lost time due to manual routing of physical documents from department to department, thus creating the inability to track the work in progress.
- Keeping track of all documents, routing for reviews and approvals and ensuring people had latest versions to work upon was becoming a challenge for the organization.
- Their quality and other departments was also having tough time fulfilling the needs of quality standards in maintaining their SOPs and other quality documents.
- Confidential documents and other important documents were sent for approval via email. Hence, there was no process in place to identify the status of the flow, which is critical for evaluation.
With a massive volume of data including documents, reports, office documents from various locations and paper-based forms, this client was looking for an Electronic Document Management Solution, to manage and control the spreadsheets and documents used in their daily business processes, reduce response times, and streamline the existing documentation procedures at the same time and bring them into compliance with 21 CFR Part 11 regulations.
The Solution – Implementation of Rupstech EDMS
Based on the client’s requirements, Rupstech offered its proven Electronic Document Management Software that could be easily extended to address the needs of our client requirements. Rupstech EDMS is a web-based GMP document management solution that allows users to create, manage, retrieve, upload, track and share documents in a highly secure environment.
The flexibility provided by the Rupstech EDMS solution enables the Customer team to make savings on employee time, not to mention the saving on physical space now that the filing cabinets have been made redundant. With seamless integration with its core business system, employees are now able to process documents of all file types.
Business Benefits – Electronic Document Management Solution
Customer employees are now using the new electronic document management solution on a daily basis and cutting their time to save and search important documents or files by many hours per month. The GMP document management solution has enabled greater control over how documents are stored, better visibility for audits, improved retention policy for different departments and a simplified data structure.
- Enhanced data quality, integrity and availability by eliminating manual, error-prone and time consuming paper-based processes.
- Getting rid of document distributed process for the reviewer and approval signatures over the document.
- Flexible configuration at document type level so that user can easily define document flow as per requirement.
- It provide facility for viewing issuance log, print log, active documents, obsolete document reports by all document users.
- Optimized workflows by harmonizing and standardizing on unified methods, SOPs, specifications and other best practices across all departments.
- Publishing quality and other documents with watermarks at each stage for distinction between master and controlled documents.
- With workflow configuration, that automated the internal file review and approval process, which can be tracked and analyzed for process optimization.
- Automatic version controlling and comparison of versions to identify the changes made.
It has also reduced the number of duplicated documents, streamlined the saving process, improved the process of scanning new documents and made it easier for customers and suppliers to follow company policies, without suffering from misfiling problems.