Deviation Handling Software for Blood Industry

Deviation Handling Software Automates Management of Deviations to Facilitate FDA GxP Compliance for Blood Industry

MasterControl Deviations Provides Automated Deviation Control and Ensures Effective Compliance with FDA's GxP 21 CFR Part 211 and 21 CFR Part 11 Requirements

The blood and biologics industry faces enormous pressure to uphold the highest GxP standards and to reduce the risks of blood and tissue contamination and infectious disease transmission. Any deviation (both planned deviation 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 blood establishments and biologics companies to be able to manage planned and unplanned deviations according to the strictest deviation management standards. The importance of deviation control in blood, blood components, and biological products are embodied by the GxP requirements found in 21 CFR Parts 600-606 and 21 CFR Part 211.

Watch Videos View Blood & Biologics 3-Minute Demo (3:00) Community Blood Center of the Carolinas (8:05) MasterControl's Documents Module (2:02)

MasterControl Deviations is a deviation handling software solution that provides automated deviation control and manages the process of documenting, investigating, and resolving operational deviations from written procedures. This solution provides the capability to resolve a deviation efficiently and to use data collected as a basis for continuous quality improvement, which is critical in FDA compliance.

MasterControl considers validation an integral part of 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.

Here's how MasterControl 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 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 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 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. 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.		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.

• 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. This best-practice form facilitates compliance with deviation-handling requirements of 21 CFR Part 211.
  
  • 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: The MasterControl deviation control software 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.

• 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. 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, this automated deviation control 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.