Manufacturing Deviation Software

DEVIATIONS PROCESSES ARE DISCONNECTED

Paper-based or manual systems are often hindered by disconnected processes, which makes standardizing and enforcing incident response procedures incredibly difficult. Without connectivity, trends and deviation occurrence patterns remain hidden. For example, a paper-based system may overlook repeated occurrences of deviations from material specifications or release specifications over a course of 30 days. As a result, the deviations go unnoticed, and therefore, uninvestigated. This can be devastating to an organization’s compliance goals, especially if the deviations are serious enough to warrant the launch of a corrective action/preventive action (CAPA).

DEVIATION PROCESSES ARE CONNECTED

MasterControl’s manufacturing deviation software allows for connectivity with other MasterControl applications that control quality processes such as CAPA and electronic batch record management. Increased connectivity and visibility make it easier for managers to spot trends and identify and resolve deviations quickly and efficiently. For example, deviation incidents can be correlated to nonconformances and customer complaints. MasterControl manufacturing deviation software enables a CRO to make the best use of its available data, and to leverage the data to maintain continuous quality improvement, as required by the FDA and other global regulatory authorities.

DEVIATIONS ARE NOT TRACKED PROPERLY

Physically tracking protocol deviations in a manual system is a time-consuming process, and the probability of human error is unavoidable. As a result, adverse events and other incidents fall through the cracks, making it almost impossible to track deviations effectively.

DEVIATIONS ARE TRACKED AUTOMATICALLY

MasterControl’s manufacturing deviation software automatically tracks all routing information and data entered into the electronic form. This allows the deviation owner to avoid omissions and understand the sequence of events during processing. MasterControl simplifies the complex, error-prone process that is typical of a manual nonconformance tracking system.

EXCESSIVE PAPERWORK BOTTLENECKS

Managing the enormous amount of paperwork generated by a manual quality management system is extremely challenging, which is why automated QMS software solutions, including electronic manufacturing deviation software, have become so popular with CROs and other regulated organizations. In a manual system, paperwork bottlenecks are inevitable, and the routing of deviations tasks and related documentation requires a tremendous amount of man-hours. A hybrid system, which requires re-entering data from hard copy into an electronic system, is just as inefficient. On the other hand, an electronic system like MasterControl averts the pressure of creating piles of papers by providing effective solutions to manage deviation process.

PAPERWORK BOTTLENECKS ARE ELIMINATED

MasterControl Deviations™ tracks all routing information and data entered into the electronic form, allowing the deviation owner to identify (and often avoid) bottlenecks, and to understand the sequence of events during processing. The solution automates management of the entire deviations process, from initiation to resolution, as well as all related documentation. Few manufacturing deviation software systems on the market today provide this level of closed-loop deviations management.