Deviations Management Software System Features & Benefits

Automating and Integrating Deviations Management Processes with Corrective Action CAPA, and Nonconformance Processes in FDA and ISO Compliance Environments

In the FDA and ISO environments, the concept of quality is made tangible by written procedures and specifications, and any deviation from them must be documented and either justified or investigated. Such deviations may occur during sampling and testing, raw material and finished product acceptance, manufacturing and product distribution. Effective investigation and resolution of deviations are an essential component of quality improvement and compliance.

How can MasterControl Deviations™ Help You?

MasterControl Deviations automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures and specifications. This solution provides the capability to resolve a deviation efficiently and to use data collected as a basis for continuous quality improvement.

Here's how MasterControl addresses some of the major challenges that companies face when resolving 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, so the quality system fails to make best use of available data. For example, a paper-based system may overlook repeated occurrences of deviations 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 MasterControl Deviations is a part of the MasterControl integrated suite, allowing connectivity with other MasterControl applications that control other quality processes. For example, deviation incidents can be correlated to nonconformances and customer complaints. MasterControl leverages the data collected for use in continuous quality improvement.
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.		Faster Turnaround MasterControl automates data collection, routing, follow-up, and escalation of deviation cases. The electronic in-box tracks all active tasks for a user and provides the tools to stay up-to-date.

Summary of 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: This best-practice workflow will guide users through the entire process of resolving a deviation incident, beginning with initiation through investigation, resolution, and approval.
• Integrated with CAPA Process: MasterControl Deviations 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 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: MasterControl Deviations 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 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.

• 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. 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.

• Compliant System: As with all software developed by MasterControl, the deviation solution is fully compliant with 21 CFR Part 11 requirements. It 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. MasterControl Deviations exceeds good-business practice requirements of companies that comply with ISO quality standards such as ISO 9000 and ISO 13485.