Best-Practice Form
The manufacturing software solution offers users an electronic pre-configured best-practice form which prompts them to gather and track all relevant deviations data. The form guides users through the complex deviations management process while allowing managers and other appropriate personnel to make the necessary decisions. In addition, the form is automatically routed to the appropriate personnel, and will escalate if not processed in a timely manner.
Simple Four-Step Process
MasterControl’s manufacturing deviation software best-practice workflow relies on a simple three-step deviation resolution process: initiation, investigation, resolution, and approval.
Robust Analytics Reporting
The solution offers a built-in analytics reporting tool that allows deviations coordinators to monitor the entire deviations management process, from initiation to resolution. For example, the tool offers a standard set of pre-configured reports which can be used as-is or customised by the end user based on company need. The tool also offers ‘data-mining’ capabilities so that both planned deviations and unplanned deviations can be trended and examined by process, product, vendor, etc. These capabilities paint a complete picture of the quality management system and provide insight into systemic quality issues.
Complies with FDA 21 CFR Part 11
Like all MasterControl software applications, the manufacturing deviation software was designed to be fully compliant with 21 CFR Part 11 requirements. MasterControl Deviations provides a secure, time-stamped audit trail, as well as robust reporting and electronic signature capabilities. In addition, the solution offers a host of security features such as dual passwords for document approval and password expiration, encryption, and certification.
Form-to-Form Launching
MasterControl takes connectivity and integration one step further by allowing user to launch a CAPA or nonconformance form directly from the deviation form. Similarly, a deviation form can be launched from a control recipe form in the MasterControl Electronic Batch Records (EBR) solution. MasterControl's manufacturing deviation software also maintains the links so that the process can be thoroughly examined and the “trigger” can be identified. Relevant information from the deviation form is automatically transferred to the launched form; this reduces the amount of data entry required which, in turn, reduces the probability of human error, and makes it easier to comply with 21 CFR Part 211 quality management requirements.
Integrates with Other Quality Processes
MasterControl manufacturing deviation software was designed to be part of a “closed-loop” enterprise QMS system and to interconnect with other critical quality management processes and solutions, including CAPA, Nonconformance, and Electronic Batch Records. For example, MasterControl Deviations was designed to integrate with MasterControl CAPA events management software so that serious deviations could immediately be escalated to the process of CAPA investigation and resolution. The solution was also designed to connect with MasterControl Nonconformance™ to enable any deviation that results in a material nonconformance to be automatically moved to the nonconformance disposition process. Finally, the software was designed to integrate with MasterControl Electronic Batch Records™ to create a complete automated solution for manufacturing operations.
