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Solving GxP Change Control Headaches

Managing changes and reviews to standards is challenging: manual tools make it difficult to collect information about proposed changes in a standardized way, while siloed systems hide this information, making reporting almost impossible. Poorly-defined processes make it hard to corral the right decision-makers (let alone collect their adjudication on decisions) and often don’t include record-keeping steps needed for auditability or even for reviewing change effectiveness and value. Regulated industries like Pharmaceutical and Life Science have it especially hard, with stringent auditing requirements and adherence to GxP standards for processes.

Macedon is proud to introduce our solution that addresses these challenges: Regulatory Change Control Management (RCCM), now available on Appian’s App Market.

This new Appian application gives Change Request Administrators an auditable way to submit, manage, and track organizational change control items, adhering to GxP standards. The RCCM solution enables you to submit, track, and manage change control requests, processes, data, and assignments through an easy-to-use centralized Appian system. Built especially to adhere to GxP standards, RCCM helps ensure that any change control process remains auditable and in compliance.

The RCCM solution makes managing change requests and change request processes easy through powerful features such as:

  • Centralized information storage/reporting - all information associated with Change Control items is stored in one place and accessible via out-of-the-box drillable Dashboards, ensuring that each person has access to the information they need to participate in the process.

  • Auditing - every facet of the Change Control process is tracked and reportable, helping to meet GxP requirements and enabling Process Performance reports.

  • Task assignments - tasks are automatically routed to their owners and displayed on dashboards, focusing employees on the work they need to do. Administrators can incorporate SLAs into assignments, communicating urgency and helping workers to prioritize their work.

  • Flexible process creation and tailoring - RCCM Administrators can easily create and tailor Change Control processes to their organizational needs, including the definition of various stages and gates (decision points) involved in the process; participants, their roles, and permissions; and the decision method used to “pass” each gate. The RCCM solution is also designed to be flexible and configurable, so you can easily modify the verbiage, stages, and approval flows to meet your business needs and unique requirements.

Learn how the new solution reduced the regular auditing process from weeks to hours for our client in this Case Study Automated Change Control System in Just a Few Weeks.


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