Nonconformance Management Software Features & Benefits
for Blood and Tissue Banks / Organizations

Nonconformance System Integrates with CAPA Software to Improve Management and Accuracy of Data Collection and the Thoroughness of Documentation

In the stringent FDA environment, a nonconforming product, material, or component could lead to costly rework and scrapping, or worse, a product recall. For blood establishments, the quality, reliability, and safety of blood products and blood components depend to a great extent on its conformance to approved specifications and parameters. FDA's Current Good Manufacturing Practice (CGMP) regulations require proper disposition of nonconformances.

The MasterControl integrated quality management suite is a configurable and easy-to-use software solution that helps blood establishments attain and sustain CGMP compliance. Recognizing that validating a software solution - and keeping it in a constant state of validation - is half the battle in sustaining FDA compliance, MasterControl offers comprehensive, full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

Watch Videos View Blood & Biologics 3-Minute Demo (3:00) How MasterControl Makes Your Job Easier (3:50) Community Blood Center of the Carolinas (8:05)

How can MasterControl Nonconformance™ Benefit You?

MasterControl Nonconformance is a configurable and easy-to-use solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. Here are some of the common challenges for high-tech manufacturing companies pertaining to nonconformance and how MasterControl addresses them. See why MasterControl Nonconformance helps ensure your system is Compliant, Connected, and Complete.

Nonconformance Challenges		MasterControl Nonconformance™ Software
Disconnected Nonconformance Processes In manual or hybrid systems, the reporting of and response to a nonconformance are likely to be disconnected, which could result in delayed resolution. A nonconformance process that's not connected to the corrective/preventive action (CAPA) system could pose serious problems in terms of the timeliness and accuracy of data collection and the thoroughness of documentation, all of which are critical to compliance.		Connected Nonconformances MasterControl's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance. MasterControl offers the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrants it.
Poor Nonconformance Turnaround A manual system is inherently inefficient. Paperwork may languish in someone's desk, and for a sequential process such as nonconformance, it could mean a delay in resolution of the incident.		Fast Nonconformance Turnaround MasterControl automates data collection, routing, follow-up, and escalation of nonconformance cases. The electronic "in" box tracks all active tasks for a user and provides tools for staying on top of things. Approvers can also review and sign electronically. All of these things help shorten cycle time.
Poor Nonconformance Tracking It is time-consuming to physically track paperwork. A manual system makes it almost impossible to identify and avoid bottlenecks.		Automatic Nonconformance Tracking The system tracks all routing information and data entered into the electronic form, allowing the nonconformance owner to identify bottlenecks and understand the sequence of events during processing.