The field of medicine has greatly benefitted from advancements in technology. Thanks to tissue and blood banks, it has become possible to identify gene patterns and mutations through research and by archiving DNA, blood, and tissue specimens. It is extremely important for such establishments to constantly monitor their procedures through audits. A quality audit is a necessary process in evaluating the state of a blood center's quality system. FDA CGMP 21 CFR Part 606 clearly states the conditions a tissue and blood bank must comply with in order to sustain business. MasterControl’s tissue and blood bank audit management software helps ensure a compliant environment.
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Research conducted by tissue and blood bank establishments is crucial in devising new approach in treatment of different diseases. These establishments carry out the groundwork for procedures and treatments that are utilized by medical facilities around the world. Organizations conducting such valued research usually require a lot of capital. MasterControl recognizes that stakes involved in this business are tremendously high and compliance is extremely important. With this in mind, MasterControl developed tissue and blood bank audit management software that makes it easier to comply with regulations by automating and managing quality audit processes in an efficient and cost-effective manner. This section elaborates how MasterControl Audit addresses some of the major challenges of both performance and compliance audits.
Tissue and blood banks are required to maintain strict documentation of their SOPs and procedures, patient and donor records, and reports of adverse reactions and incidents, among other things. In a manual system, it is extremely difficult to maintain documentation and conduct audits. A manual or hybrid system requires a lot of time and effort in performing the same set of activities and tracking audit findings and related corrective / preventive actions (CAPAs). Such systems are inefficient and lack the capacity to manage simultaneous audits. MasterControl Audit provides a centralized web-based repository for all audit documentation that makes search and retrieval easy. Each step of the audit process is automated so that scheduling, planning, and execution of the audit can be completed without any hassle. MasterControl’s best-practice audit forms track basic audit information, such as scope, checklists, audit team, and audit status. MasterControl can also integrate audit with CAPA process to track CAPAs.
In order to maintain compliance with FDA regulations, it is important to conduct different types of audits on a recurring basis, including internal, customer, and compliance audits. The frequency of these audits depends on the size of the company. A manual system relies on a team member to schedule these audits and to delegate appropriate tasks. If this person is less than vigilant, it is likely that a task may be overlooked. A manual system lacks the capability of efficiently following up tasks. Since tasks are assigned either through phone or e-mail, it is difficult to see their progress.
With MasterControl tissue and blood bank audit management system, scheduling of audits, assignment, and notification of tasks are automated and can be handled well in advance to ensure that they are not overlooked.
MasterControl tissue and blood audit management software also automates task escalation to ensure that tasks that are not completed by deadline are brought into the management’s attention.
Completion of a task can be made dependent on another task to give managers more control of the workflow and reduce cycle time by prompting users immediately to their next task. An innovative dependency tree illustrates relationships between dependent processes.
It is critical for management to get a big picture of its blood audit management program on a regular basis. However, electronic spreadsheets, flowcharting software, and paper documents in binders lack the capability of providing the much needed insight about different business process areas. The MasterControl tissue and blood bank audit management system offers customizable reports, online charting, and all the necessary tools that will provide management with enhanced insight and analysis of the company’s overall business situation. Through the reports, managers get a real-time view of the blood audit process and can be more proactive about improving their quality system.
MasterControl Audit is a complete and robust solution that integrates the different steps necessary for a successful blood audit, including preparation, scheduling, execution, findings, verification, and completion. MasterControl's tissue and blood bank audit management software is 100 percent web-based so auditors and other users can access it from virtually anywhere. Some of its powerful features are elaborated in the section below:Best-Practice Forms
MasterControl provides two important forms that collect and track data throughout the audit process and streamline the audit workflow to promote efficiency. The Audit Summary form is for planning and preparing for any internal or third-party audit. Basic information such as type of audit, date, description, objective, scope, audit area, and lead auditor is easily tracked. The form also gathers information that serves as the basis for the audit and its various aspects. The Audit Finding form, as the name suggests, tracks all the findings that result from the blood audit. The form integrates risk management to identify severity of risks and other related attributes. The MasterControl tissue and blood bank audit management system also ensures proper closure by tracking verification of the process owner's response to the finding.Connected Quality Processes
A robust and compliant quality system consists of well-functioning subsystems that are associated with each other. This connectivity is a hallmark of MasterControl’s holistic approach. With MasterControl, you can launch a CAPA form directly from the Audit Finding form, connecting one process to the next. The entire audit process is streamlined with links that will help you review a completed process and easily see what triggered that process. Relevant information from the Audit Finding form is automatically entered into the CAPA form which reduces manual data entry. MasterControl's tissue and blood bank audit management software also shows the history of the entire process, making it easy to review the chain of all events in the audit.Analytics and Reporting Tool
MasterControl's advanced analytics and reporting tool allows management to customize reports based on their business requirements. The following customizable reports are available in the MasterControl tissue and blood bank audit management software system:
Audit Summary - Gives a concise view of all the in-process audits and their status, as well as future audits.
Audit Detail - Gives a detailed view of the audit findings, including related CAPAs.
Findings by root cause.
Audits by Standards - Lists audits categorized by standard (i.e., ISO 9001:2000, Sec. 8.2.2) or by regulation (i.e., FDA GMP Part 820.22).
Audits by Auditor - Lists audits categorized by the auditors conducting them.
Open Findings - Lists open findings categorized by owners.
The MasterControl tissue and blood bank audit management software features the Explorer, a tool for quickly finding documents. The Explorer, similar to Windows Explorer, can help you categorize audit documents by area, or location, or standard/regulation. Although the tissue and blood bank audit management system stores all documents in one consolidated location, virtual folders allow data fencing. This means that data of each department is secure and out of reach by other departments. Pre-defined queries make it easy for departments to find and retrieve their documents.Sustained Compliance
A strong audit management process is a prerequisite for compliance with FDA regulations and ISO standards. MasterControl Audit is designed not only to help you attain FDA and ISO compliance, but to sustain it by streamlining the audit program. The MasterControl tissue and blood bank audit management system cultivates efficiency throughout the enterprise and keeps compliance costs down. With MasterControl Audit, tissue and blood bank establishments can count on a partner that supports compliance efforts over the long haul.
To learn more about MasterControl's tissue and blood bank audit management software systems, feel free to contact MasterControl representative today.