The BIOIVIA Signal Monitoring Dashboard (SMD) solution is a purpose-built validation-ready environment that satisfies requirements for Continued Process Verification (CPV), process robustness and process performance visibility needs across local operations and global manufacturing networks that include Contract Manufacturing Organizations (CMO’s). Automated alerts driven by a sophisticated and flexible rules engine provide review-by-exception for efficient Process and Product Monitoring (PPM) that includes direct connections to process and quality databases as well as CFR 21 Part 11-compliant capture of paper based data.
Process Monitoring And Continued Process Verification Challenges
Recent industry trends as well as updates to the regulatory guidelines have prompted pharmaceutical, biotechnology and medical device manufacturers to look more closely at process and product monitoring. Manufacturers want more robust and predictable processes to reduce business risks and improve process economics. They also want to satisfy regulatory expectations for routine monitoring of critical in-process and final product parameters for every batch to ensure that the process continues to operate in a validated state.
The goal is to be proactive rather than reactive, and to provide a high assurance of product safety with evidence from every manufactured batch, that all parameters are operated within their desired limits, not just the final product specifications. An efficient monitoring program is a cost-effective way to implement Stage 3 of the updated guidelines for process validation, namely Continued Process Verification. By providing operating staff and their support teams with alerts so they can take action before batches begin to fail, a monitoring by exception system can reduce production costs and delays. Managers and executives also need summarized visibility into process performance across processes and plants as appropriate for their roles, and with the ability to drill down into the details when needed.