LEADING GLOBAL PHARMACEUTICAL COMPANY

Controlled Document Management System for Contract Manufacturer

case-study-3

CLIENT : FASTEST GROWING CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION (CDMO)

BACKGROUND:

  • Client is growing through rapid expansion
  • Automation and business process streamlining is key to scale up to ensure customer satisfaction and compliance

KEY HILIGHTS

  • Centralized repository to author and retrieve documents.
  • Management of underlying workflows and lifecycles.
  • Audit trails.
  • Electronic signatures.
  • Watermarking.

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.

– CEO

BUSINESS CHALLENGE:

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:

  • Manual processing: The organization manually dealt with a variety of both Controlled and Non-Controlled documents through its central team referred to as the Doc Center. The process required manually routing of Document Change Requests for review and approval across business functions like Engineering, Operations, Quality Control, Quality Assurance, Doc Center etc., before a Controlled Document(SOP’s, Forms, Batch Records – MBRs and PBRs etc.) could be authored, reviewed, approved and made effective or retired. This process became extensively complex with organizational growth and expansion resulting in lower productivity and efficiency.
  • Security and Compliance: The organization stored most of the documents in physical form. While some of the Master Controlled Documents were converted into electronic copies and stored on a Shared Network Drive, a majority of them were stored in a physical archive and there were no audit trails on actions performed by various users.
  • Productivity & Performance: With most documents stored in physical archive, retrieval of submission documents based on client requests was time consuming and challenging. There were also instances when certain documents could not be located as they were either physically archived in Doc Center or sitting in some users cabinets or on the File Share.
  • Ineffective Collaboration: There were coordination issues with regard to meeting clients requests or responding to their queries. The process of author, review and approval of documents was managed through emails and this often caused time delays.

DOCMATION SOLUTION:

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.

KEY BENEFITS:

  • Achieved increased productivity, information accuracy, better control of processes and improved compliance and customer satisfaction.
  • Using Documentum’s Workflow and Lifecycle, the Docmation team automated the client’s business process. This simplifies approval process and retention of records.
  • Strong version control and audited distribution of SOPs ensures that only the lasted versions are in circulation and users are properly trained on the correct procedures.
  • Real-time access to documents enabled clients to respond promptly to customer requests for docmation required for compliance and FDA submissions.
  • Solutions enabled the client to track the usage of content. Functionality for usage and status reports within Documentum was created.

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