{"id":63907,"date":"2022-04-22T19:28:15","date_gmt":"2022-04-22T17:28:15","guid":{"rendered":"http:\/\/www.veeva.com\/eu\/?post_type=resources&p=63907"},"modified":"2026-03-23T17:24:26","modified_gmt":"2026-03-23T16:24:26","slug":"white-paper-streamline-change-control-for-cdmos","status":"publish","type":"resources","link":"https:\/\/pantheon.veeva.com\/eu\/resources\/white-paper-streamline-change-control-for-cdmos\/","title":{"rendered":"Streamline Change Control for CDMOs"},"content":{"rendered":"

\nDrive continuous quality improvement by connecting people, processes, and technology\n<\/p>\n

Today\u2019s Reality: The Broken Change Control Process<\/h2>\n

\nApproved product changes impacting multiple products and business functions require all parties to
\ncoordinate to record and exchange information on time. However, because of separate processes and systems,
\nbusiness functions communicate via phone calls and emails, making cross-functional collaboration difficult.
\nMiscommunication among stakeholders often leads to change execution without full impact assessment,
\nresulting in downstream activities that are not justified by the benefit of the change.\n<\/p>\n

\n\"\"\n<\/div>\n

\nThis broken and inefficient change control process increases compliance risk and delays product ship
\ndecisions.\n<\/p>\n

\nUnifying disconnected systems and processes on a modern cloud platform builds the foundation for change
\ncontrol transformation. This paper provides a holistic approach to streamlining the change control process
\nto improve quality, compliance, and time-to-market.\n<\/p>\n

The Opportunity: Connecting People, Processes, and Technology<\/h2>\n

\nStreamlining change control requires improvements in three core areas: people, processes, and technology.
\nOptimizing the relationship between these three elements increases efficiency and accelerates product shipments.\n<\/p>\n

\n\"\"\n<\/div>\n

People: Establish a Change Control Board<\/h3>\n

\nDriving a successful transformation project requires buy-in from key stakeholders across all business functions.\n<\/p>\n

\nA change control board can help establish the right governance model and gain cross-functional alignment.
\nThis central function can drive a global and consistent change control process, bringing clarity and improving
\ncollaboration. A streamlined change control process that supports all types of changes can also help prioritize,
\nbundle, and implement changes most cost-effectively.\n<\/p>\n

Processes: Implement a Risk-based Approach<\/h3>\n

\nNot all changes are equally important; bringing all stakeholders across all changes reduces agility and lowers
\nproductivity.\n<\/p>\n

\nA risk-based approach simplifies and speeds the change control process while maintaining the right level of
\nquality oversight.\n<\/p>\n

\nStart by classifying risks in different tiers depending on the nature and extent of the changes. Each change
\ncategory specifies the level of involvement for various stakeholders. For example, while a facility change may
\ninvolve regulatory, supply chain, manufacturing, and IT stakeholders, a minor system update may involve only
\nIT and quality teams.\n<\/p>\n

Technology: Unify and Connect Systems<\/h3>\n

\nChange control teams need the right intelligence at the right time at each step of the change control process,
\nand modern technology can enable that.\n<\/p>\n

\nUnifying multiple processes and applications on a modern cloud platform lets you manage and track the entire
\nchange management process in a single workflow. Three unification opportunities to automate and accelerate
\nthe change control process are:\n<\/p>\n

    \n
  1. Unifying and connecting quality systems<\/li>\n
  2. Streamlining change requests and approvals with customers<\/li>\n
  3. Enabling supplier collaboration and visibility<\/li>\n<\/ol>\n

    \nUnifying and Connecting Quality Systems<\/strong>\n<\/p>\n

    \nDisparate document management, change control, and training systems create various disconnect points
    \nacross the change control process. A quality system landscape with complex cross-application integrations
    \ncannot enable full automation, increasing manual tasks to manage the change control workflow and duplicate
    \ndata entries.\n<\/p>\n

    \nA unified quality environment automates and streamlines the change control process by eliminating manual
    \ntasks and the need for complex integrations.\n<\/p>\n

    \n\"\"\n<\/div>\n

    \nFor example, changing a material used in the manufacturing process may require SOP changes. Having change
    \ncontrol and document management in one system can automatically identify impacted documents and trigger
    \na document change action.\n<\/p>\n

    \nOnce documents are updated and approved, the system can trigger a training action to re-train users on the
    \nnew procedure.\n<\/p>\n

    \nThis automation, multiplied across hundreds of changes per year, brings significant efficiencies. More
    \nchanges can be resolved faster, reducing the time spent following the \u201cpaper trail\u201d and ensuring a thorough
    \ndocumentation update process and timely user training.\n<\/p>\n

    Streamlining Change Requests and Approvals with Customers<\/h3>\n

    \nBy connecting the exchange of information in a unified cloud environment, quality teams can ensure a change
    \nto a product or system is introduced in a controlled and coordinated manner. The customer can work within the
    \nsame system to easily communicate, review, and approve change controls \u2014 significantly expediting the change
    \ncontrol process.\n<\/p>\n

    \nFor example, if a supplier needs to change out a piece of equipment it would generate various change actions
    \nthat can now be quickly reviewed and approved by impacted customers within the same system\n<\/p>\n

    \n\"\"\n<\/div>\n

    Enabling Supplier Collaboration and Visibility<\/h3>\n

    \nAs the reliance on external suppliers and partners continues to increase, integrating them into quality processes
    \nis essential to optimize manufacturing cost and bring drugs to regional patients faster.\n<\/p>\n

    \nA unified cloud platform like Veeva Vault can bring the complex ecosystem of suppliers into the change
    \ncontrol process, improving collaboration and providing end-to-end visibility. User-level permissions and built-in
    \ndata integrity controls enable you to provide secure access to suppliers, making it easier to get the required
    \ninformation for change approval and monitor their change implementation activities.\n<\/p>\n

    The Result: Streamlined Change Control<\/h2>\n

    \nThe holistic approach to streamlining the change control process enables you to:\n<\/p>\n