Quality Management System for Blood and Tissue Industry

Qualityze Inc attends ISO 9001 and Audits World Conference, gains valuable insights on quality management and auditing!

Tampa, FL USA, 23rd March 2023: Qualityze is pleased to announce our recent participation in the ISO 9001 and Audits World Conference. The event took place on March 13-14, 2023 and brought together professionals around the globe to discuss quality management and auditing. The ISO 9001 and Audits World Conference is a premier event in […]

Quality Management Software for Blood and Tissue Industry

Through the development of safe blood supply and transfusion, high quality is introduced as a culture. To achieve this, quality systems (QS) and quality management systems (QMS) are used. There are five key components: organization (structure), standards (technical and quality), documentation to ensure traceability and proof, education, which includes training and instruction, and assessment, which provides ongoing monitoring and evaluation. Many QMSs are available that apply to the procurement and use of blood in clinical settings. Those who are “process”- and “operations-oriented” tend to be more focused on the operational aspects; those who are more focused on the management aspects ensure a quality environment and culture, which underpins consistency and reliability. But the growing needs imply for a comprehensive system like Qualityze EQMS Suite.

The Next-Generation EQMS system, Qualityze EQMS, is an innovative, user-friendly solution created for the Blood and Tissue industry. The solution simplifies quality processes while reducing compliance and operational risks. It runs on the most powerful and secure platform, i.e., Salesforce.com. As an added benefit, the centralized platform of the solution improves visibility and traceability. Data analysis can help you identify recall trends of the blood products and improve quality accordingly. By doing so, you can also improve brand reputation and loyalty.

The Qualityze EQMS software for Blood and Tissue Industry is a closed-loop quality system. It includes Document Management, Change Management, Nonconformance Management, CAPA Management, Incident Management, Audit Management, Training Management, Complaint Management, EBR Management, Calibration Management, Maintenance Management, Supplier Quality Management, Inspection management, Permit Management, Material Compliance Management, Forms Management, and Field Safety Management with exciting features like Audit Trail, Digital Signature, Validations, Dashboards, Reports, and Analytics.

Advantages of Quality Management Software for the Blood and Tissue Industry

All screening programs of blood and tissue establishments should use a quality management system to ensure efficacy, safety, and quality. First, it ensures the quality of blood screening. A QMS helps implement organizational management, quality standards, documentation, traceability, training, assessment, and maintenance. In addition, it helps establish quality guidelines to perform all screening tests and correctly handle donations and components before, during, and after laboratory testing. Finally, it ensures that blood transfusion services and laboratories consistently implement best practices and specified standards. You can gain the following benefits by using an end-to-end Quality Management System for Blood and Tissue companies:

  • Improved Business Processes
  • Improved Document Control
  • Enhanced Traceability and Lowered Costs
  • Improved Customer Service
  • Better Insights for Planning & Decision-Making
  • Improved Supply Chain Operations

Improved Business Processes

Quality Management in a blood bank requires process quality control. Quality controls of blood products play a critical role in ensuring that potential donors receive timely access to a high-quality blood component with maximum efficacy and minimal risk. Quality control starts with blood donation, provided by prospective donors of various ages and with different risk factors, demographics, and health profiles. It is mainly a manual process that may be subject to operator variation. Variations of this nature have the potential to compromise the critical control points which are designed to improve blood quality. That’s where a QMS comes to use. It standardizes processes, eliminates the challenges of manual processes, and ensures more consistency in donor data.

Improved Document Control

A quality management system significantly improves how an establishment manages its controlled documents – be it training manuals, procedures, or instructions. An effective quality management system ensures that blood and tissue operations meet quality standards, minimize the possibility of errors, and reduce downtime due to the ability to access relevant data quickly. It further enables easy monitoring of the processes so you can analyze the process outputs and make adjustments accordingly. Since one size fits all approaches don’t work nowadays, you must implement a configurable, cloud-based document management system that can integrate with your existing quality systems.

Improved Customer Service

Ensure that your donors receive the attention they deserve, or you will lose their trust and confidence in your services. Due to this, you must implement new ways to improve customer services, including a quality management system. An integrated QMS helps you improve customer service in transfusion services. The solution will allow you to categorize donor complaints and incidents, identify recurring incidents, simplify after-service experience, group customers with frequent or recurring incidents, and enable customers to follow the progress of their tickets. Therefore, implementing a quality management system will help transfusion services resolve their customer complaints faster and more efficiently.

Enhanced Traceability and Lowered Costs

A blood transfusion service must know where a blood product or reaction originated from at any time, so they can query, “who donated or received the blood?”. A quality management system should contain documentation allowing tracking of blood products from donor to recipient and vice versa. Blood and clinical services need to work closely together to improve and optimize transfusion safety. Therefore, tracing blood products is crucial for ensuring patient safety. It aims to retrieve the donor and recipient histories of donated blood by retrieving a donation number. You can simplify all this using a quality management system. It builds a closed-loop system to ensure traceability. It further reduces the costs involved in administrative work to manage all the donor and recipient records, historical data, and much more.

Better Insights for Planning & Decision-Making

In transfusion medicine, blood safety and quality are crucially important. Therefore, blood establishments must ensure that their activities meet quality and safety standards. Establishing an effective quality management system (QMS) is vital to reaching this goal. The QMS incorporates risk-based thinking and continuous and properly evaluated quality monitoring in all phases of the vein-to-vein transfusion process to be fully effective. It significantly improves the planning and decision-making to enhance transfusion services continuously. The QMS, nowadays, comes with advanced reporting and analysis capability so that you can drive maximum value from the data collected in the centralized database.

Improved Supply Chain Operations

Blood transfusion has attained an increased level of safety and is now among the better-managed care activities. This achievement was due to scientific advances and policy decisions that regulate and supervise the training and the quality system implemented to achieve quality management. A quality management system impacts the entire organization, including its structure, responsibilities, processes, supply chain, and resources. A quality management system establishes a framework for developing, implementing, and continuously monitoring activities to improve outcomes. The quality of this system applies to all players in transfusion, as much to the blood transfusion institutions as to the health institutions and the suppliers who timely deliver blood samples and organs for transplants.

How Does Qualityze Works for the Blood and Tissue Industry?

 
EQMS software for Biologics Industry

How Does Qualityze Works for the Blood and Tissue Industry?

The Qualityze EQMS Suite provides 16 intelligent quality solutions meant especially for the Blood and Tissue Industry. The tool can benefit all companies, large and small when it comes to compliance and operational excellence. Qualityze lets companies manage quality data efficiently and securely on the Salesforce platform. Next, let’s look at how each module works in the Blood and Tissue industry:

Nonconformance Management Software for Blood and Tissue IndustryNonconformance Management

The blood establishment should document its procedures for handling nonconformities and train its employees on managing them. You must clearly define each step, from identifying nonconformities to deciding on the activities associated with nonconformities, analyzing trends, and timely reporting of nonconformities. Further, it is essential to clearly determine the responsibilities of participants in these activities. A manual approach to nonconformance management may consume more time. You should rather implement Qualityze Nonconformance Management. It enables you to streamline all the nonconformance-related activities in a standardized manner. It further ensures blood product quality and safety, donor or patient safety, institution reputation, and compliance with applicable standards. With the software, you’ll get features like Digital Signature, Alerts and Notifications, Email Approvals, Centralized Database, Audit Trails, 3rd Party Integration, and much more.

CAPA Management Software for Blood and Tissue IndustryCAPA Management

The transfusion facilities take corrective action for nonconformities, which may adversely affect the quality system, patient safety, buyer confidence, and reputation due to their frequency or importance. Nonconformities that are serious or critical require immediate action. Such problems require effective tools for solving because continuous corrective actions lead to improved customer satisfaction and product quality. One such tool is Qualityze CAPA Management. The system simplifies the efforts needed to identify and correct quality problems, preventing their recurrence, essential for blood establishment compliance with Current Good Manufacturing Practices (CGMP) found in 21 CFR Part 606. In addition, it automatically records all the CAPA details on a centralized database for improved accessibility and traceability. Therefore, the Qualityze CAPA software system for tissue and blood banks can improve compliance and efficiency.

Document Management Software for Blood and Tissue IndustryDocument Management

Documents like Standard Operating Procedures (SOPs) and Clinical Transfusion Guidelines (CTGs) play an integral role in quality management. Additionally, they serve as tools for evaluating patient care because they guide supporting processes and clinical practices. Thus, maintaining consistency across all documents is essential. It is also vital to update all documentation periodically. Obtaining this level of control will require a document management system like Qualityze. Using this software, hospital administrators can manage all transfusion-related documents securely as part of the quality management system. It is a cloud-based system that provides more control and flexibility to both the blood establishment and hospital blood bank to prepare and update policies and procedures related to the logistics of blood components.

Change Management Software for Blood and Tissue IndustryChange Management

When change is not managed efficiently in the blood and tissue industry, it can lead to severe consequences for the patients and the establishments. Some of them include increased risk to patients and inadequate crisis management. Even the change takes longer to introduce and is not done in a coordinated way. It further leads to noncompliance with the regulations. The best solution to combat this situation is implementing a robust change management solution like Qualityze. It enables blood establishments to standardized change management processes to make the entire process simple and efficient. It creates a closed system with best-practice workflows to drive effective change and a culture of continuous improvements. Meeting compliance becomes effortless too.

Audit Management Software for Blood and Tissue IndustryAudit Management

Transfusion services are primarily concerned with maintaining a safe and adequate supply of blood components for therapeutic purposes. Hence, blood and its components are important components of patient management protocols because, like drugs, they can cause adverse reactions in recipients. Clinicians and intravenous therapists should fully understand blood component therapy to maximize effectiveness, safety, and utility. Thus, an audit of blood and its components is necessary to understand blood utilization patterns and formulate ideal policies in all specialties. This information is vital for improving transfusion medicine practices. You can manage it all using Qualityze Audit Management System. It is a powerful tool to manage end-to-end audit processes and information, all on the cloud.

Training Management Software for Blood and Tissue IndustryTraining Management

FDA has specified guidelines for managing blood and tissue-based products from donor screening to deviation reporting for human cells, eligibility criteria to proper labelling, and validation of procedures especially for transplants. It becomes critical for blood and tissue establishments to keep their employees trained on all the best practices to ensure safety and compliance. That’s where Qualityze Training Managements  comes to use. You can create document-based and instructor-led training using this software. It enables to track the participant performance for the training with assessments. The system automatically generates the certificates for the employees who successfully complete the training. Most importantly, it can be integrated with enterprise document management system to manage training related documents with flexibility and security.

Supplier Quality Management Software for Blood and Tissue IndustrySupplier Quality Management

GMP mandates the purchase of materials from approved suppliers and that the manufacturer must know the suppliers well. An evaluation of supplier reliability should include assessing their ability to provide materials of consistent quality with adequate evidence should be part of supplier qualification. The supplier qualification process should also identify and minimize the risks associated with the material in question. Thus, GMP manufacturers must set up a robust supplier qualification program. The assessment of suppliers should be documented formally and available to inspectors during GMP inspections. You can achieve all this using Qualityze Supplier Quality Management. It enables establishments to streamline processes to evaluate, audit, and assess suppliers based on compliance requirements. You can also create an approved supplier list with whom you want to do business.

Complaints Management Software for Blood and Tissue IndustryComplaints Management

Complaints management requires collecting and analyzing complaints data and acting on that data. The management of patient complaints requires two factors. In the first place, patients should be allowed to share feedback on their experiences (e.g., the care they receive, the expertise of the staff, and the availability of supplies) and complain when their experiences don’t match their expectations. To improve the effectiveness of quality improvement processes (QI) and human resource management (HRM), the health system must be able to analyze, respond to, and utilize patient feedback. It can be achieved by integrating patient complaints into a full-fledged system like Qualityze Complaints Management that enables establishments to respond to feedback timely and always follows up.

Calibration Management Software for Blood and Tissue IndustryCalibration Management

From measuring blood Hb levels to its absolute flow, everything needs to be done with well-calibrated equipment to ensure accurate results. That’s the reason blood and tissue establishments must have a powerful calibration system like Qualityze Calibration Management in place to maintain their equipment measurement accuracy within tolerance limit specified. It enables establishments to streamline their calibration activities in regular intervals to avoid measuring issues. It is suitable for establishments having multi-site set-up. Whether you want to schedule the calibration activities or maintain the calibration records in a centralized database, Qualityze simplified the entire process for you. Would you like to experience the most simplified way of managing equipment calibrations? Get Qualityze Calibration Management today.

Maintenance Management Software for Blood and Tissue IndustryMaintenance Management

The maintenance of laboratory equipment is an essential part of quality assurance. It is necessary to maintain well-maintained lab equipment so that data are consistent and reliable. Since laboratory equipment usually consumes a large budget, good maintenance also minimizes the likelihood of premature repurchases and replacements. Additionally, routine maintenance helps identify and repair damaged laboratory equipment components and systems to ensure safety. You can streamline the entire maintenance process with Qualityze Maintenance Management. It maintains a log of maintenance activities performed, including replacement, repair, refurbishing, and much more. In addition, you can set automatic alerts for the maintenance schedules, so no maintenance activity is due.

Inspection Management Software for Blood and Tissue IndustryInspection Management

A health professional regulatory agency must perform regular inspections at the sites of blood, tissue, organ procurement organizations, or transplantation centers as defined by law. Inspecting an establishment is designed to determine if it complies with the law and identify any violations. It may be necessary for the HPRA to conduct additional inspections at establishments/centers to make sure they comply with the law. That’s where Qualityze Inspection Management can be of help. It helps streamline the inspection process from start to finish. Second, it enables the establishment to identify gaps against the Regulations and Good Practices requirements. Third, it helps generate comprehensive reports and escalate issues for further investigation and effective resolution.

Permit Management Software for Blood and Tissue IndustryPermit Management

A facility that manufactures human cells, tissues, and products derived from those cells and tissues is required to register and list its products with the Food and Drug Administration (FDA) according to 21 CFR part 1271. Registration and listing of HCT/Ps must be done within five days of operations beginning, and registrations must be updated annually. As a result, you are likely to miss the annual deadlines or may experience delays with the traditional approach. But Qualityze Permit Management can help prevent all such events. In addition, it enables you to keep track of permit and license renewals for your testing labs and other facilities.

Material Compliance Management Software for Blood and Tissue IndustryMaterial Compliance Management

In the blood and tissue industry, conflict mineral-containing products or those containing undetermined metal compositions requiring further assessment include syringes, electronic components, and other mechanical components. These measures must meet the OECD Guidelines for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas and their supplements in all material respects. Qualityze Material Compliance Management can help you with that. It automates processes and informs suppliers about conflict minerals. The supplier can then assess its supply chain’s transparency and identify the smelters/refiners involved in the process. Highly intuitive and configurable, the software enables you to build best-practices workflows following your business quality objectives.

Forms Management Software for Blood and Tissue IndustryForms Management

A blood and tissue establishment need to gather different data types, such as clinical patient data, standards and metadata for sequencing, cytometry data, drug screening data, and histopathology imaging data. A hospital’s electronic health records, surgical operation notes, and sample collection forms are generally used to collect data. This job, however, was mainly manual and partially based on exports. For example, a clinical record can include patient data, such as demographics, surgical procedures, imaging results, chemotherapy and other treatments given to patients, blood test results, and information on patient survival and treatment outcome. Conventional methods of collecting data may not be efficient in this area. It would be better to use a powerful tool like Qualityze Forms Management Software. It enables you to create different forms with required fields and number schemes to collect data in one place. You can quickly analyze and track all the critical data. As a result, making decisions will be easier.

Field safety Management Software for Blood and Tissue IndustryField Safety Action Management

Drug regulation applies to blood components. Due to their direct human origin, they will always be subject to biological variation. Also, these medications are produced, tested, stored, distributed, and recorded on a unit-by-unit basis, allowing for more deviations. As per the FDA, best practices apply even after the drug is manufactured, which means if there is a problem with the final product, it needs to be fixed or prevented from harming patients. Consequently, blood suppliers have recalled and withdrawn blood components more frequently than ever, and transfusion services have received more notices about blood products. Many of these recalled units appear to present a “risk of a risk” (i.e., if the problem had been present, the patient could have been affected, but the severity is often unknown). With Qualityze Field Safety Management, transfusion services and blood suppliers can streamline their recall management process, evaluate health hazards, and reduce risks of non-compliance.

Incident Management Software for Blood and Tissue IndustryIncident Management

As a result of transfusion, immediate transfusion incidents occur include acute hemolytic transfusion reactions, febrile non-hemolytic reactions, allergic reactions, transfusion-associated circulatory overload (TACO), and reactions related to bacterial contamination of the blood bag, transfusion-related acute lung injury (TRALI), hypotensive reactions, and non-immune hemolysis. Managing and reporting these incidents requires much work that can be further simplified using an advanced Incident Management Solution like Qualityze. It is a cloud-based software that comes with configurable workflows so you can manage incidents in alignment with applicable regulations. In addition, the solution has powerful in-built capabilities that reduce overall process cycle time by accelerating approvals, investigations, and resolution. Would you like to experience Qualityze difference for simplified incident management?

EBR Management Software for Blood and Tissue IndustryEBR Management

A great deal of information is associated with the activities of blood, tissue, and cell therapy establishments. During cell therapy and product processing, data generated needs to be recorded and structured to adhere to best practices, regulations, and prevailing standards. Since cell therapy products are active pharmaceuticals, a batch process record (BPR) model is proposed to collect data from processing cell therapy products. In addition, cell-processing facilities and electronic data-recording tools must be used based on regulatory or accreditation requirements. It is here that Qualityze Electronic Batch Record Management comes in. It provides you complete flexibility to configure BPR forms that standardize the process for batch data collection. In addition, it reduces the overall administrative workload to manage, analyze, and track batch records. Get Qualityze EBR Management today to achieve production and compliance excellence. 

Why Choose Qualityze Enterprise Quality Management Solution for Blood and Tissue Industry?

Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Blood and Tissue industry because it has

Still Thinking?

Qualityze EQMS offers a lot of value to any organization with its customizable cloud-based software for Non-Conformance Management, CAPA Management, Document Management, EBR Management, Change Management, Training Management, Supplier Management, Inspection Management, Complaints Management, Incident Management, Calibration Management, Maintenance Management, Permit Management, Material Compliance Management, Forms Management, and Field Safety Management.