Regulatory Change Control Management

Overview

Managing change across any organization is challenging: manual tools make it difficult to collect information about proposed changes, while siloed systems hide this information, frustrating reporting efforts. 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 have it especially hard, as they need to meet stringent auditing requirements. For example, companies in the Life Sciences industry must adhere to GxP standards for processes.

Key Features & Functionality

The RCCM solution leverages a number of benefits from Macedon’s Stage and Gate component to make managing change requests and change request processes easy:

• Centralized information storage/reporting: all information associated with Change Control items is stored in one place, and accessible to users via out-of-the-box drillable Dashboards, ensuring that each user has access to the information they need to participate in the process.
  
  
• Auditing: every facet of the Change Control process is tracked and recallable, helping to meet GxP requirements, and enabling Process Performance reports.
  
  
• Task assignments: tasks are automatically routed to their owners, and are displayed on Dashboards, focusing users on the work that they need to do. Administrators can incorporate SLAs into assignments, communicating urgency and helping users 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 builds on Stage and Gate functionality by defining a standard Change Control process that can be used out of the box. This process is broken into the following stages, each stage including a set of tasks to be completed; a set of stage-specific documentation; and approval steps:

• Submit/Review
• Impact Assessment
• Implementation Preparation
• Implementation
• Closure
• Effectiveness Check

Benefits & Business Impact

The RCCM solution enables organizations across any industry to submit, track, and manage their 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 is designed to be flexible and configurable, such that any organization using it can modify the verbiage, stages, and approval flows to meet the needs and unique requirements of their business. Should further customization be needed, RCCM is the perfect accelerator to form the foundation of any change control process.