Quality Management System for Compounded Drugs Industry

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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 Compounded Drugs Industry

It is essential for Compounding Pharmacy manufacturers to maintain a greater level of viability. As a result, the organization often needs to simplify processes and contain costs on time. But it doesn’t end there. The transformations happening in high-profile R&D departments present numerous other challenges for Compounded drug companies. The challenges include managing product-specific challenges that increase costs, lack of market transparency, and uncertainties associated with regulatory requirements, as well as an irregular supply chain. Therefore, Compounded drug manufacturers need a quality management system to streamline all critical processes, like manufacturing, distribution, and supply chains, while improving overall transparency. The right eQMS can help mitigate quality, compliance, and operational risks too.

Qualityze EQMS Suite is the next-generation QMS for the Compounding Drugs industry. It enables organizations to efficiently manage critical processes, including inspection, training, supply chain and documentation. Built on the most powerful and secure platform, i.e., Salesforce.com, it leverages pre-defined templates and configurable workflows to reduce process cycle time. In addition, it provides the Compounded drug manufacturers transparency through the processes and trends to make improved business decisions.

The Qualityze EQMS software for Compounded Drugs Industry is a closed-loop quality system. It includes Document Management, Change Management, Nonconformance Management, CAPA Management, EBR Management, Permit Management, Audit Management, Training Management, Incident Management, Field Safety Action Management, Complaints Management, Inspection Management, Supplier Quality Management, Material Compliance Management, Forms Management, Calibration Management, Maintenance Management, Field Safety Management, Incident Management with exciting features like Audit Trail, Electronic Signature, Social Collaboration, Dashboards, Reports, and Analytics.

Advantages of a Quality Management Software for the Compounded Drugs Industry

Quality Management System for Compounded Drugs Industry

Whether it is about streamlining the medical supply chain to overcome Compounding Pharmacy shortage or meeting compliance with applicable regulatory requirements, an integrated quality management system help ensures quality and safety of every product delivered to the customer. A QMS simplifies and streamlines the processes to ensure consistent quality products.  Here’s an overview of all the benefits that you can leverage with the integration of end-to-end quality managment software for the Compounded Drugs industry: 

  • Improved Business Processes
  • Improved Document Control
  • Improved Customer Satisfaction
  • Improved Internal Communication
  • Reduced Operational Expenses
  • Improved Supplier Relationships

Improved Business Processes

Whether it’s about managing product change or an event resolution, a quality management software simplifies the process management and reduce the overall cycle time. Once streamlined properly, the processes will yield consistent results. The integrated software also provides increased visibility into trends that helps improve planning and decision-making. Therefore, a quality management software lets you manage your business processes in a smarter, better, and efficient manner.

Improved Document Control

Compounding Pharmacy also require maintaining extensive documentation due to the many standards applicable in preparing safe drugs and compliance training. Therefore, the organization needs a document control system to manage, maintain, and track critical documents securely and efficiently. Collecting business information more efficiently is more straightforward and more confident with a quality management software system that integrates all the processes into a closed loop. The advanced document management software provides you required flexibility and security to manage and share documents across different business sites. Furthermore, companies can maintain all the records versioned on an organized repository with a software solution.

Improved Customer Satisfaction

Customer satisfaction is one of the main goals for any business. Success depends on how well it resolves customer complaints and meets customer expectations regarding the safe compounding of medications. It is here that quality management software can be helpful. By transforming customer feedback and complaints into opportunities for improvement, it helps make a positive impact. The better the product quality, the more loyal and trusting the customer is. A quality management software automatically records the complaints details and the relevant action plans implemented, which further helps organization take a proactive approach towards risks and quality issues.

Improved Internal Communication

For compounded drug manufacturers, safety is their top priority. Therefore, their employees need comprehensive training to ensure a consistent quality of products. However, it takes time to train personnel thoroughly and entails a lot of documentation. You can manage it all with comprehensive quality management software that helps manage training requirements for different job functions. The software also helps improve overall engagement within the organization by providing your workforce a centralized platform to communicate and collaborate for reviews, document changes, and other critical tasks.

Reduced Operational Expenses

Despite its reputation as a contributor to rising drug costs, compounded drugs might represent a solution for the seemingly impossible problems of generic price increases. Nevertheless, the FDA has still developed a new regulation scheme, which requires facilities engaged in large-scale and sterile compounding activity to register, pay annual fees, comply with current good manufacturing practices (cGMPs), and submit to FDA inspection. A quality management software can help significantly reduce these costs by enabling pharmacies to meet compliance requirements and perform regulatory reporting and submissions at regular intervals. It will help them reduce operational expenses to a large extent, eliminating additional costs of outsourcing regulatory submissions.

Improved Supplier Relationships

Suppliers play an important role in achieving quality objectives by providing materials that meet critical requirements set out in specifications. Therefore, evaluating supplier capability and performance will help the organization maintain excellent customer service and experience. It is why Compounded drugs companies need a closed-loop quality management system that can help them address supplier quality and operational risks. You can easily find a cloud-based eQMS that can integrate with the existing business systems to help you manage supplier data and performance in a well-organized manner. Further, it will help you improve your relationship with suppliers, and it will help you communicate with suppliers more effectively.

How Does Qualityze Works for the Compounded Drugs Industry?

A Compounded Drugs company can take advantage of Qualityze 14 smarter quality solutions to meet their specific needs. It can help companies of all sizes achieve operational excellence and ensure compliance. Based on Salesforce, Qualityze provides companies with secure and flexible access to quality data. Find more details about how each module functions in the Compounded Drugs industry:

EQMS software for Compounded Drugs Industry

How Does Qualityze Works for the Compounded Drugs Industry?

A Compounded Drugs company can take advantage of Qualityze 12 smarter quality solutions to meet their specific needs. It can help companies of all sizes achieve operational excellence and ensure compliance. Based on Salesforce, Qualityze provides companies with secure and flexible access to quality data. Find more details about how each module functions in the Compounded Drugs industry:

Nonconformance Management Software for Compounded Drugs IndustryNonconformance Management

To solve quality issues before the medicine reaches the patient, compounding drug manufacturers require a robust system to document nonconformances discovered during the production cycle. The Qualityze Nonconformance Management System is a complete solution for collecting, managing, and tracking nonconformances during the compounding process. Also, it helps categorize non-conformances into major, moderate, and minor problems to address them on time. The closed-loop quality system allows organizations to foster a culture of continuous improvement throughout the production process. Furthermore, it facilitates meeting compliance requirements and delivering safe compounded drugs.

CAPA Management Software for Compounded Drugs IndustryCAPA Management

In the world of compounded drugs, safety is the primary concern, which is why different dosage strengths or forms are created, followed by omitting components from FDA-approved drugs to which a patient is allergic. To ensure quality and safety, it becomes even more imperative to deal with them in a timely and compliant manner. The Qualityze CAPA Management Solution simplifies and optimizes CAPA processes for risk mitigation. When organizations use CAPA workflows, they can identify inconsistencies in dosage or forms and remediate them appropriately. Moreover, Qualityze automatically records the preventive and correction actions taken against potential nonconformances.

Document Management Software for Compounded Drugs IndustryDocument Management

A Compounded Drugs industry includes managing documents such as drug formulations, standards, testing procedures, and guidelines. Modern businesses require enhanced accessibility and traceability of critical documents, and traditional document management systems may not be able to meet these needs. Use of an integrated solution such as Qualityze would be the most effective way to handle document-related challenges. It simplifies the process of managing electronic documentation with unmatched accuracy and security. It comes with sophisticated security controls including role-based access, password authentication, digital signature validation, among others. Furthermore, you can use the Watermark function to ensure the credibility of packaging, labeling and best-practice guidelines to follow for drug formulations.

Change Management Software for Compounded Drugs IndustryChange Management

Compounded pharmacies face compliance challenges. Manually maintaining policies, manuals, and specifications for numerous regions and all their versions may prove to be problematic in the long run. Count on Qualityze Change Management Solution for a reliable solution. The software enables manufacturers of compounded drugs to standardize their change management processes for operational excellence. This solution minimizes time and efforts associated with change management processes, due to its advanced capabilities. No matter what your needs are, Qualityze Change management makes it all simple. You can notify or track previous changes. In an environment where processes and procedures are constantly changing and evolving, our solution helps you stay compliant.

Audit Management Software for Compounded Drugs IndustryAudit Management

For consistent quality compounding drugs, it is essential to perform quality checks and audits at every production stage to avoid quality issues, rework, lawsuits, and other severe consequences. Having a comprehensive audit management process in place to meet compliance requirements is even more critical considering customers’ growing expectations. It will help them achieve quality, identify process flaws, and foster an environment that encourages continuous improvement. The best solution to manage the whole audit cycle is Qualityze Audit Management, which contains the entire audit process compliant. In addition, this audit software features predefined audit checklists, reducing the amount of work and time involved with conducting an audit. You can also schedule audits and notifications in advance to ensure your teams stay on top of things.

Training Management Software for Compounded Drugs IndustryTraining Management

Compounding drug organizations need to train their employees about risk reduction, achieving high safety standards, develop safe formulations, and maintaining hygiene. Unfortunately, modern business environments may not accommodate traditional training systems. To manage your training effectively, you should use Qualityze Training Management Software. Cloud-based training solution is intuitive and customized to meet pharmaceutical training requirements. The tool enables you to create document-based and trainer-led training successfully with/without assessments. Creating comprehensive training programs for different jobs, departments, and roles ensures that all employees receive the same level of expertise.

Supplier Quality Management Software for Compounded Drugs IndustrySupplier Quality Management

Finding a good supplier is difficult when it comes to manufacturing compounding drugs. You cannot rely on initial samples quality, which is generally quite reliable. However, even with the right partner, quality still fades. To avoid these issues, a quality audit before onboarding a supplier is essential. It is easy to tell if a supplier is adhering to its quality systems by checking their quality system. Regular supplier audits enable manufacturers to monitor their production and quality controls during production. Here, Qualityze Supplier Quality Management comes into play. The software helps organizations streamline entire supplier lifecycle processes, such as selection, audits, and inspections, based on industry-proven best practices. You can manage supplier-quality metrics with ease by taking advantage of the configurable workflows and intuitive user interface.

Complaints Management Software for Compounded Drugs IndustryComplaints Management

Patients receiving compounded pharmaceuticals are encouraged to report adverse event reports, including how and where to contact. Pharmacists must act expeditiously when reporting a reported event, particularly if the patient is hospitalized or dies. Also, the findings of investigations should be provided to the patients, prescribers, and other external parties such as state boards of pharmacy within 14 days after the incident. It can take a long time to conduct manual proceedings. Qualityze Complaints Management Solution comes in handy in such scenarios. The software streamlines and automates the entire complaint process, from filing a complaint to investigating the event, resolving it, and submitting a report.

Calibration Management Software for Compounded Drugs IndustryCalibration Management

In the Compounding Pharmacy industry, it is imperative to maintain the temperature and voltage requirements for testing equipment. Therefore, it’s best to calibrate the equipment used regularly. Nevertheless, manual procedures have a chance of missing calibrations now and then. Moreover, it could result in the wrong dosage or form, further causing complications. You can keep all these risks at bay if you use Qualityze’s Calibration Management Solution. It helps you schedule, track, and manage all calibration activities about a given piece of equipment. Furthermore, a centralized platform automatically stores all calibration records, so you can use them during regulatory inspections and audits to demonstrate best practices.

Maintenance Management Software for Compounded Drugs IndustryMaintenance Management

In compounded medications, ingredients are mixed according to a patient’s unique needs and proportioned appropriately. It is also crucial to keep your testing kits and equipment maintained. Qualityze Maintenance Management Solution allows you to schedule, manage, and track complex equipment for compounding and testing your drugs. Manage equipment maintenance schedules more effectively with this fully integrated tool that seamlessly integrates your existing business applications. The system automatically sends alerts for the approvals and maintenance activities that are due. Furthermore, you can easily track the history of maintenance activities performed and actions implemented for the equipment that cannot be maintained further.

Inspection Management Software for Compounded Drugs IndustryInspection Management

Compounding drugs use raw materials sourced from numerous suppliers, so quality control checks must be in place to avoid quality issues during production. Manually performing the process can be a time-consuming and resource-consuming endeavor. But it is crucial for long-term relationships. To maintain output quality, you need the right tools and resources, like Qualityze Inspection Management Solution. It simplifies pre-production, ongoing, and post-production inspections. Using Qualityze Inspection Management, you can evaluate whether repeat inspections are necessary and generate NCs for all nonconforming materials found in the inspection.

Permit Management Software for Compounded Drugs IndustryPermit Management

Whether you are in heavy manufacturing, light manufacturing, or the manufacturing facilities subject to the 40 CFR Part four standards for stormwater effluent discharges, you must obtain an NPDES permit under the stormwater program. In addition to this, there are several other licenses and permits required from the federal, state, and local governments to run your manufacturing business. Using the traditional pen and paper system, managing them all can make things complicated and time-consuming. Instead, it would be best to implement a smart permit and license tracking system like Qualityze. It is the one-stop solution for efficiently managing and tracking business permits for both single and multi-site operations. You can also set notifications to notify users of due renewals, approvals, and reviews.

Material Compliance Management Software for Compounded Drugs IndustryMaterial Compliance Management

A compounding pharmacy’s ability to create personalized medicine is essential in the care of patients who have special needs or are allergic. The dosage forms of many commercially available medications are not explicitly formulated for these specific populations, e.g., liquid formulations for children who have difficulty swallowing tablets. Also, compounded products can be used for treating rare diseases or times of shortages of drugs. A modified drug product can be a topical ointment, eye drop, solid or liquid oral dosage form, or an intravenous infusion. It becomes even more critical for compounding pharmacies to understand the role of responsible mineral sourcing to avoid any health risks for their patients. Qualityze Material Compliance Management can help compounding pharmacies to keep a track of minerals they are sourcing and using in the customized products.

Forms Management Software for Compounded Drugs IndustryForms Management

In an industry like compounding pharmacies, where the scope of forms ranges from general prescription forms to specific order forms, one cannot undermine the importance of a robust forms management solution. Choosing the right forms management software like Qualityze can save loads of administrative time and efforts that your teams often spend on paperwork. Qualityze Forms Management is a configurable solution that helps organizations to capture, manage, and track the valuable data insights from their customers, stakeholders, and suppliers efficiently. It comes with pre-defined templates to accelerate the entire data collection process. Moreover, it ensures consistency and accuracy of the information capture. The digital signature capability of the solution helps verify the critical details pertaining to the compounding pharmacies, all on a centralized platform.

Field safety Management Software for Compounding Pharmacy IndustryField Safety Action Management

In the event of a recall, pharmacy staff should notify prescribers and employees responsible for administering prescriptions of the recall. The most common methods include telephone calls, e-mail notifications, memos, staff meetings, posters, and flyers. In addition, identification of patients taking the recalled product should be made by reviewing dispensing records and sample logs. Finally, a patient must be informed when the law, regulation, or organization policy mandates that a medication recall be conducted. Managing all these activities individually may take longer, and you will have lesser control over data. With Qualityze Field Safety Management, you can manage recalls from start to end. It streamlines post-market surveillance activities to identify the product safety issues and mitigate them timely.

Incident Management Software for Compounding Pharmacy IndustryIncident Management

In cases where FDA-approved medications cannot be used, compounded drugs can be the best option for patients. Before marketing, the FDA does not review compounded drugs for safety, efficacy, or quality. To protect the public from potentially dangerous compounded drugs, FDA requires prompt, detailed, and accurate reporting of adverse events or complaints. It is pharmacists’ role to identify problems with compounded drugs and relay these problems to the FDA. Compounding Incidents Program reduces risk and raises public awareness of compounded drug safety issues by following up, taking action, and following up on incidents. That’s where Qualityze Incident Management comes into action. It helps streamline all the incident management and reporting activities. The configurable workflows and intuitive interface of the solution make incident management processes even simpler.

EBR Management Software for Compounding Pharmacy IndustryEBR Management

Compounding Records ensure that a product is prepared following its corresponding Master Formulation Records according to its batch in the compounding drugs industry. Final checks are performed on the preparation using the CR. If a recall occurs, the CR determines which ingredients were in the practice that a particular patient received. Therefore, the pharmacist and technician must always ensure that CRs are accurate and complete. Managing all the records and associated activities using manual record management can take time and effort. Implementing a next-generation solution like Qualityze Electronic Batch Record Management would be best. It has exceptional in-built capabilities to make batch record management easy and efficient. You can leverage digital signature validation to authenticate information and processes at every step. You can either configure the batch record form or use the pre-defined templates from the system to standardize batch data collection. 

Why Choose Qualityze Enterprise Quality Management Solution for Compounding Pharmacy Industry?

Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Compounded Drugs industry because it has

Still Thinking?

Qualityze Compounded Drugs QMS software has a lot of value to offer to any organization with its customizable cloud-based software for Nonconformance Management, CAPA Management, EBR Management, Document Management, Change Management, Inspection Management, Training Management, Incident Management, Field Safety Action Management, Supplier Quality Management, Audit Management, Material Compliance Management, Forms Management, Incident Management, Complaints Management, Permit Management, Calibration Management, Field Safety Management and Maintenance Management. You must give it a try!