Manufacturing Deviation Software

Manufacturing Deviation Software Automates the Management of Deviations to Help Ensure FDA GxP Compliance

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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CxOs must meet the highest levels of accuracy and quality standard. Any deviation (both planned and unplanned deviation) from approved procedures for production and process control could potentially affect quality, and therefore, compliance. While it's impossible to completely avoid deviation, the FDA expects contract organizations to be able to manage planned and unplanned deviations according to the strictest deviation management standards. MasterControl helps in providing such solutions and manufacturing deviation software for the companies to ensure regulation compliance.

How can Manufacturing Deviation Software from MasterControl Benefit You?

MasterControl Deviations™ consists of manufacturing deviation management software that automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures, including release specifications and material specifications. This solution provides the ability to resolve a deviation efficiently and to use data collected as a basis for continuous quality improvement.

Continuous Validation With Manufacturing Deviation Software for FDA GMP Compliance

MasterControl considers validation an integral part of manufacturing deviation software for FDA-regulated customers. Our 'continuous validation' approach dramatically cuts the time, pain, and cost involved in validation, making it easier to validate future upgrades. MasterControl's continuum of products and services address different levels of validation needs based on individual risk assessment.

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). This greatly reduces validation requirements, validation time, and the overall cost of validation.

Here's how MasterControl addresses some of the major challenges that companies face when resolving planned deviations and unplanned deviations.

Deviations Management Challenges		MasterControl Deviations™ Software System
Disconnected Deviations Processes A paper-based or hybrid system, which consists of disconnected processes, faces a significant challenge in enforcing uniform incident response. The scope of a deviation is usually focused on a single event, rather than a series of events over time. Trends and patterns in occurrence remain hidden but MasterControl offers manufacturing deviation software to provide easy to manage solutions regarding deviations. So the quality system fails to make best use of available data. For example, a paper-based system may overlook repeated occurrences of deviations from release specifications or material specifications over a span of 30 days, and consequently fail to alert managers about the need to investigate it, or perhaps launch a corrective/preventive action (CAPA).		Connected Processes The manufacturing deviation software from MasterControl allows connectivity with other MasterControl applications that control quality processes, including CAPA, OOS, and electronic batch record management. For example, deviation incidents can be correlated to nonconformances and customer complaints. MasterControl leverages the data collected for use in continuous quality improvement required by the FDA.
Poor Tracking of Deviations It's time consuming to physically track paperwork. A manual system makes it almost impossible to identify and avoid bottlenecks.		Automatic Tracking of Deviations The system tracks all routing information and data entered into the electronic form, allowing the deviation owner to identify bottlenecks and understand the sequence of events during processing.
Poor Turnaround For those with paper-based systems, paperwork often ends up in a pile on somebody's desk, creating a significant turnaround challenge in a sequential process, even if that process involves a small group. MasterControl averts the pressure of creating piles of papers by providing effective solutions to manage deviation process.		Faster Turnaround The system tracks all routing information and data entered into the electronic form, allowing the deviation owner to identify bottlenecks and understand the sequence of events during processing.

Managing Both Planned and Unplanned Deviations With Manufacturing Deviation Software

MasterControl's manufacturing deviation software is an ideal solution for controlling deviation incidents, for helping avoid their recurrence, for taking a proactive approach to continuous quality improvement, and for ensuring FDA and GMP compliance. Below is a summary of its key features.

• Best-Practice Form and Process : A pre-configured, multi-page form prompts participants to collect and track all relevant data and guides them through the process while allowing responsible personnel to make the appropriate decisions. The form is automatically routed to the appropriate personnel and can escalate if not processed in a timely manner.
• Four-Step Process with Electronic Approval Signatures: Manufacturing deviation software procides the best-practice workflow which will guide users through the entire process of resolving a deviation incident, beginning with initiation through investigation, resolution, and approval.
• Integrated with CAPA Process: The manufacturing deviation software from MasterControl can be integrated with MasterControl CAPA™, so serious cases can immediately move on to the process of corrective/preventive action investigation and resolution.
• Integrated with Nonconformance Process: When manufacturing deviation software from MasterControl is integrated with MasterControl Nonconformance™, any deviation that results in a material nonconformance will automatically move to the nonconformance disposition process.
• Integrated with Electronic Batch Records Process: The manufacturing deviation software from MasterControl connects with MasterControl Electronic Batch Records™ to create a complete automated solution for manufacturing operations.
• Form-to-Form Launching: A CAPA form or a nonconformance form can be launched directly from the deviation form. By the same token, a deviation form can be launched from a control recipe form in the MasterControl Electronic Batch Records solution. MasterControl's manufacturing deviation software also maintains the links so a completed process can easily be reviewed to see what triggered it. Relevant information from the deviation form is automatically transferred to the launched form, reducing data entry and increasing accuracy. This integrated approach makes it easier to comply with 21 CFR Part 211 quality management requirements.
• Analytics Reporting Tool: This built-in tool comes with a standard set of pre-configured reports that can be adjusted and customized by the end user. Planned deviations and unplanned deviations can be trended and analyzed by process, product, vendor, etc. These 'data-mining' capabilities can give important insight into systemic quality issues and serve as yet another starting point for CAPA.
• FDA 21 CFR Part 11 Compliant System: As with all software developed by MasterControl, the manufacturing deviation software is fully compliant with 21 CFR Part 11 requirements. Manufacturing deviation software provides a secure, time-stamped audit trail, reporting, and electronic signature capabilities. Security features include dual passwords for document approval, and password expiration, encryption, and certification.
• ISO 9000, ISO 13485 Standards : MasterControl Deviations exceeds good-business practice requirements of companies that comply with ISO quality standards such as ISO 9000 and ISO 13485.

For More Information about Manufacturing Deviation Software

For more information about deviation management software, in particular, manufacturing deviation software from MasterControl, please feel free to contact a MasterControl representative.