Product Deviation Software
MasterControl Product Deviation Facilitates Effective Compliance with FDA's GMP 21 CFR Part 211 and 21 CFR Part 11 Requirements
MasterControl Product Deviation Facilitates Effective Compliance with FDA's GMP 21 CFR Part 211 and 21 CFR Part 11 Requirements
MasterControl Product Deviation Facilitates Effective Compliance with FDA's GMP 21 CFR Part 211 and 21 CFR Part 11 Requirements
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The biotechnology or biological product sector of the pharmaceutical industry is at the forefront of the development of the most advanced and complex medicines and therapies today. Given the complexity of the field, biotech companies face strict regulations that require the highest levels of accuracy and quality standard. Any product deviation (planned or unplanned) from approved procedures potentially affects quality, and therefore, compliance.
Sometimes called an out-of-specification (OOS) result, a biological product deviation may occur during sampling and testing, raw material and finished product acceptance, manufacturing, and product distribution. Effective control of every biological product deviation from material specifications and release specifications is an essential component of quality improvement and compliance.
The MasterControl deviations software solution automates and manages the documentation, investigation, and resolution of every biological product deviation from written procedures, including release specifications and material specifications. The software not only efficiently resolves a deviation, but uses the data collected as a basis for continuous quality improvement, which is also critical to FDA compliance.
MasterControl considers validation an integral part of our software solutions 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 and product deviation.
Here's how the MasterControl software for biological product deviation addresses some of the major challenges that companies face when resolving planned 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 product deviation is usually focused on a single event, rather than a series of events over time. Because trends and patterns of occurrence remain hidden, the quality system fails to make best use of available data. For example, a paper-based system may overlook repeated occurrences of biological product deviation from release specifications or material specifications over a 30-day timeframe, and consequently fail to alert managers about the need to investigate the deviation -- which can in turn require a corrective/preventive action (CAPA). | Connected Processes MasterControl Deviations is a part of the MasterControl integrated suite, allowing connectivity with other MasterControl applications that control other quality processes, including CAPA, OOS, and electronic batch record management. This allows a biological product deviation to 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 an electronic form, allowing the owner of the biological product deviation to identify bottlenecks and understand the sequence of events during processing. |
Poor Turnaround With a paper-based system, paperwork often ends up in a pile on somebody's desk, creating a significant turnaround challenge in a sequential process, even if that product deviation process involves a small group. | Faster Turnaround The system tracks all routing information and data entered into an electronic form, allowing the owner of the biological product deviation to identify bottlenecks and understand the sequence of events during processing. |
MasterControl Deviations is an ideal deviation management software solution for controlling product deviation incidents, for helping avoid their recurrence, for taking a proactive approach to continuous quality improvement, and for assuring FDA and GMP compliance. The software's key features are outlined below.
For more information about product deviation or deviation management software, please feel free to contact a MasterControl representative.