Manufacturing
Manufacturing Deviation Software
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.
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How MasterControl's Manufacturing Deviation Software Benefits CROs and Other Regulated Organizations
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.
Continuous Validation for FDA GMP Compliance
Software validation 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.
The top three challenges regulated companies encounter when attempting to resolve deviations
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 |
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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. |
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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. |
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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. |
MasterControl’s Manufacturing Deviation Software Makes it Easy to Manage both Planned and Unplanned Deviations
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.
MasterControl's Manufacturing Deviation Software Beneficial Features:
Best-Practice Form
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
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
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 customized 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
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
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
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.
Meets ISO 9000, ISO 13485 Standards
In addition to being FDA 21 CFR Part 11 compliant, the MasterControl solution exceeds good-business practice (GMP) requirements of ISO-regulated companies that adhere to the following ISO quality standards: ISO 9000 and ISO 13485. This type of assurance gives highly regulated organizations increased peace-of-mind, and allows them to focus on their core business, instead of compliance.
