Blood and Tissue Banks
Quality Management Software for Blood Centers and Blood Banks - Electronically Automate Document Control, Change Control, Corrective Actions, Training Management, Audits, and Other Quality Control Processes
There is no substitute for blood. Just as important, there is no substitute for blood quality and safety. From cancer patients to premature babies, the quality of the blood that patients get can make the difference between life and death. It is no wonder that blood establishments face some of the toughest regulations and standards today. The Food and Drug Administration (FDA) wants to make sure that blood donated annually by 5 million people is free from disease, and that the process of blood collection and transfusion is safe.
Blood banks and transfusion centers are covered by a number of regulations, including the FDA's 21 CFR Parts 600, 606, 21 CFR Parts 210-211, 21 CFR Part 11 (for those maintaining electronic record-keeping systems), and the Clinical Laboratory Improvement Amendments (CLIA). In addition, many blood establishments affiliated with hospitals, adhere to quality standards by the College of American Pathologists, a professional organization that provides voluntary accreditation. Public companies or those planning to go public or are acquired by public companies are covered by Sarbanes-Oxley Act (SOX) requirements.
A blood establishment's ultimate goal is to ensure blood quality and safety. To achieve this goal, the organization must address many challenges, including:
- Inefficient Quality System: Blood establishments with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs, donor records, and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during inspections and accreditations.
- Disconnected Processes: Quality processes that are not connected to each other can cause delays and poor results. For example, a corrective action process that's not connected to the rest of the quality system may produce an unreliable root cause investigation due to inadequate information.
- High Cost of Validation: 21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a blood establishment successfully automates its manual SOP management and other record-keeping systems, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost.
Compliance is a state, not an event. Companies part of the American Association of Blood Banks AABB, must not only attain compliance, but sustain it year after year. The MasterControl? integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance with FDA and other regulations by automating and managing quality processes in an efficient and cost-effective manner.
Recognizing that validating a software solution ? and keeping it in a constant state of validation ? is half the battle in sustaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
Roll over the list of solution categories below to view the related MasterControl product, then click to go to that solution's product page.
MasterControl Documents™ helps increase the quality unit's efficiency and effectiveness by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation, making search and retrieval easy. MasterControl Documents, the core application in the MasterControl quality management suite, integrates all quality processes such as change control, customer complaints, corrective/preventive action, audits, etc., for a closed loop solution.
MasterControl Change Control™ streamlines the entire change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change implies great impact on the product and is likely to require regulatory filing. Customizable reports provide real-time status not only of change control tasks but of the entire quality system.
The MasterControl CAPA™ solution interconnects different quality subsystems and tracks incidents that can escalate into a corrective action. It includes a best-practice "8D" process to guide the quality team through every step of CAPA implementation, from identification of the problem through corrective action. A CAPA form can be launched directly from another form (e.g., nonconformance or deviation report), automatically entering relevant data into the CAPA form, reducing data entry and eliminating errors from manual transfer of information. Through the Internet, customers, vendors, and others outside the company can submit customer complaint or other forms that could lead to CAPA.
MasterControl Training™ automates assignment and monitoring of training tasks and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed, the next one is automatically launched. Provides group sign-off feature for verifying training of large groups of employees. Training control can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.
The MasterControl Audit™ solution automates, streamlines, and effectively manages the audit process. It provides advanced tracking capability, from scheduling and planning to execution and completion. MasterControl offers best-practice forms for tracking basic audit information and audit findings. It automates scheduling of all recurring audit-related activities and provides advanced analytics and reporting capability, so managers get a real-time view of the audit process.
MasterControl Submissions™ facilitates electronic delivery of FDA applications (such as IND, NDA, and BLA) by providing control in assembling and tracking necessary documentation. It provides appropriate templates to streamline the dossier-creation process. MasterControl can be integrated with leading e-submission applications, connecting approved documents and forms-based content with the dossier assembly process, to accelerate submissions.
MasterControl Customer Complaints™ streamlines the complaint-handling process and reduce the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with a resolution of the issue. MasterControl's advanced reporting capabilities increase management oversight and demonstrate appropriate controls to regulatory agencies. MasterControl is Web-based, so customers can submit complaints from virtually anywhere.
The FDA's 21 CFR Part 11 requires full-cycle validation of electronic record-keeping systems to assure the accuracy, reliability, and consistent intended performance of the system. MasterControl provides comprehensive validation services, including onsite IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) tests to ensure that the system is fully compliant. For companies wanting to perform their own validation, MasterControl offers a Validation ToolKit, which provides a detailed, pre-written validation test protocols and scripts.
For companies seeking compliance with the Sarbanes-Oxley Act (SOX), the MasterControl SOX™ is a complete and easy-to-use solution that automates and effectively manages business processes, including voluminous documents, records, and SOPs. It includes a pre-configured form that documents and collects data pertaining to risks, internal controls, and tests. It links every risk with its control and test through pre-built workflows. It allows testing to be automatically scheduled and incorporates escalation to ensure that tests are completed.
For many small pharmaceutical and biotech companies, GCP stands for "Great Complicated Paperwork" rather than “Good Clinical Practices.� The voluminous paperwork is an integral part of meeting the international, ethical, and scientific quality standards for designing, conducting, recording and reporting trials that involve human subjects, but that doesn’t make it any easier to handle. Small contract research organizations (CROs) commonly feel overwhelmed by all the documentation required by the standard.
MasterControl attends the annual American Assocation of Blood Banks AABB trade show each year. For more information about AABB, visit their website:
American Association of Blood Banks AABB
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