Change Control Management/Engineering Change Orders

Change Control Management for pharmaceutical companies and Engineering Change Orders (ECO) for medical device companies are included with the Document Control module of Title21 Software. However, when implemented with the Quality and Training modules, the change control process can be automated across the entire organization. A change order can be launched directly from a CAPA event, then all documents that need to be altered to reflect the change can be linked on the same form. Training tasks, tests, and notification can be launched with automatic email notifications to ensure the training is completed in a timely manner, closing the loop.

Moving to an electronic system automates the review, approval, implementation, and disposition process based on specific procedures. It also provides a centralized repository for all change control or ECO related documentation that makes search and retrieval easy.

An out-of-the-box form is available to capture the description of change, justification, and impact. However, our configurable forms tool can alter the form to meet each company’s specific needs. Some of the other fields included are: evaluation of the risk assessment, change in terms of training, validation, and regulatory requirements, links to other ECOs or change orders. A coding system can be installed that categorizes changes for advanced reporting and statistical analysis.

The task manager automates task assignment and follow-up via automatic e-mail notification. Any recurring change order/ECO related activities can be included in a task profile, however users have the option to add tasks on an ad-hoc basis to individual change order events. Quality Manager incorporates escalation capability for any task not completed by deadline.