Manufacturing deviation software facilitates compliance with FDA's 21 CFR Part 211, 21 CFR Part 820, and 21 CFR Part 11 requirements.
Contract research or manufacturing organizations (CxOs) are subject to the same rigorous FDA regulatory requirements as the pharmaceutical and medical device companies that sponsor them. CxOs that help make medical devices are covered by the FDA's 21 CFR Part 820 and they are likely to be certified to ISO 13485 if they sell their products overseas. CxOs contracted by pharmaceutical companies must comply with such regulations as 21 CFR Parts 210-211. Contract organizations that maintain electronic systems like manufacturing deviation software to comply with predicate rules also do meet 21 CFR Part 11 requirements surely.
Because any deviation (whether planned or unplanned) from approved production control procedures can affect quality, and therefore, compliance, CROs must maintain the highest levels of quality and accuracy. While it's impossible to completely avoid deviations, the FDA expects CROs to address planned and unplanned deviations according to the strictest deviation management standards. MasterControl manufacturing deviation software, MasterControl Deviations™, was designed to help CROs and other regulated organizations adhere to these stringent standards. By automating the process of documenting, investigating, and resolving operational deviations from written procedures, including release specifications and material specifications, MasterControl Deviations enables CROs to resolve deviations quickly and efficiently, and to use the collected data as a foundation for continuous quality improvement
Software validation, also known as software quality control, is the process of ensuring that a software application is working properly. For FDA-regulated customers, software validation is extremely important. Manufacturing deviation software that does not address validation as a critical component can compromise an organization’s quality goals. MasterControl’s 'continuous validation' approach dramatically cuts the time, pain, and financial cost involved in software validation, and makes it easier to validate future upgrades. In addition, our solutions incorporate completed validation and support documentation of IQ/OQ tests performed at MasterControl (in the form of transfer operational qualification or TOQ), which significantly reduces validation requirements, the amount of time need for validation, and the overall cost of validation. This allows an organization to start achieving its quality and compliance goals almost immediately, which is a huge competitive advantage.
Listed below are the top three challenges regulated companies encounter when attempting to resolve deviations followed by examples of how MasterControl’s automated manufacturing deviation software addresses those challenges.
|Deviations Management Challenges||MasterControl Deviations™ Software System|
|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.
Manual deviations management systems may seem inexpensive in the short-term, however, their lack of efficiency and accuracy can cost CROs and other regulated manufacturers a great deal of time, money, and stress in the long-term. MasterControl's manufacturing deviation software offers these organizations a better, more efficient solution for controlling planned and unplanned deviation incidents and avoiding their recurrence. Organizations who rely on MasterControl to assist them in their deviation management efforts are taking a proactive approach to maintaining continuous quality improvement and FDA/ GMP compliance. Here are some of the solution’s most beneficial features:
For more information about deviation management software, in particular, manufacturing deviation software from MasterControl, please feel free to contact a MasterControl representative.