Regulatory Change Control Management

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.

The Regulatory Change Control Management (RCCM) solution builds on Macedon’s 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.