The implementation of the Controlled Document Management Solution helped our organization with improved productivity and efficiency. With all the Controlled and Non-Controlled documents housed in the centralized repository, security and compliance is no longer a concern.
With increased operational efficiency, we are now in a better position to respond our clients with their documents queries in a timely manner.
Client is a leading Contract Development and Manufacturing Organization(CDMO) serving the pharmaceutical industry and offering its customers with a wide range of comprehensive services beginning from the development through the manufacturing of a variety of drugs. Providing outsourced services to the pharmaceutical market involved organizing and integrating issues. In order to streamline the process and to offer its services in a more coherent and standardized manner, the client opted for a rapid expansion.
The rapid expansion brought fourth numerous challenges in terms of Compliance, Security, Stability, Collaboration and Productivity related issues:
The organization considered implementing a Controlled Document Management Solution using state-of-the-art industry standard technologies in order to improve process efficiencies and to achieve standardization. Docmation team worked in collaboration with the organization to implement the solution and address Controlled Document such as Corporate and Development Standard Operating Procedures(SOPs), Master and Packaging Batch Records and Stability protocols, Stability Reports, Test Methods, Specifications, Policies etc. The internal process to create, review, approve and also to watermark documents for their publishing can be easily done using the automated system. Docmation worked with the Doc Center team at the organization, which previously handled these processes, to define and establish the standardized life cycles, workflows and electronic signature policies for the system. The existing paper copies of the master document were digitized for better collaboration.
The solution is based on EMC’s LSQM(Life Sciences Quality Manufacturing), built on top of Documentum D2 Platform. It provided the facility for managing of all the controlled documents. In addition Documentum Captiva was used for document Capture that enabled users to scan and index the documents directly into the Centralized Repository.
Centralized repository of enterprise wide controlled documents was created. The solution also helped to streamline business process using workflows and lifecycles to regulate enterprise-wide documentation process for SOPs, corrective actions, and validation documents that are critical to compliance.