What are Quality Management Systems (QMS) in Pharma?

What is Quality Management?

Quality Management is the set of processes that enable delivery of high-quality products while maintaining regulatory compliance. Its purpose is to ensure that all organizational processes are conducted in a documented, consistent, and controlled manner.

An electronic Quality Management System (eQMS) is a formalized, digital system that helps manage your organization's policies, procedures, and controls. An effective QMS allows life sciences organizations to not only meet regulatory standards, but also continuously improve over time. Typically, a QMS contains different modules, with each one enabling you to carry out a specific quality process.

Why You Need an Electronic Quality Management System (eQMS)

Quality plays a critical role in safeguarding public health and maintaining the integrity of pharmaceutical products and medical devices. The importance of an eQMS in this responsibility cannot be understated.

Since the pandemic, paper-based processes have become all but obsolete. Electronic accessibility and management of quality records is not only possible, but obligatory for agile companies. Unfortunately, many life sciences organizations use disparate systems to manage quality processes. This approach has multiple drawbacks. Data is often siloed, making it a challenge to reconcile and verify information in every system. Multiple-point solutions require employees to dedicate excessive time to managing a system rather than focusing on value-add activities to support strategic process improvement.

With the evolution of system capabilities, many eQMS solutions now support and integrate the following processes:

• Document Control: Manage the lifecycle of specifications, policies, and other important documents through version control and a centralized repository.
• Quality Event Management: Report and resolve deviations to improve the quality of your organization's products and prevent reoccurrence of nonconformances. Other quality events that may be managed include findings, deviations and CAPAs.
• Training: Create, assign, and track completion of trainings so employees are educated on the latest procedures.
• Audits & Investigations: Conduct audit planning, execution, and follow-up to ensure compliance and identify opportunities for improvement (CAPAs).
• Supplier Management: Manage service providers and suppliers to enhance visibility into the supply chain. Often includes the generation of supplier corrective action requests (SCARs).

Four Benefits of an Effective eQMS

While there are numerous benefits of a well-implemented quality management system, here are four key objectives your organization will fulfill:

1. Increase Efficiency: By streamlining deviation, audit, and CAPA processes, organizations can better address issues and proactively mitigate the occurrence of nonconformities. Many QMS are closed-loop systems, providing full control of processes from identification of deviations to effectiveness check completion. Not only can an eQMS ensure timely execution of quality processes, but it can also reduce manual work.
2. Make Data-Driven Decisions: Using customizable and insightful reports, quality teams can monitor key metrics such as severity of nonconformances, cycle times, and overdue trainings. By identifying trends via visualizations and dashboards, quality teams can develop actionable insights and inform higher-level decision makers.
3. Improve Compliance: In the medical device, pharmaceutical, and biotech industries, companies must adhere to strict regulations. Life sciences organizations produce a high volume of documents and records, many of which are subject to inspections. A unified QMS provides user-friendly interfaces, a centralized repository, and clear traceability, which reduces duplicative efforts and human error. Cloud-based QMS often permit role-based access, which improves data security. You can be confident that any information reviewed by regulators is accurate and up-to-date.
4. Enhance Collaboration: Today, document authoring and Supplier Corrective Action Requests (SCARs) may rely on back-and-forth emails in your organization. With the latest collaboration features, eQMS allows document editors to work in real time and suppliers to provide responses directly in the system. A centralized system reduces reliance on multiple communication methods; instead, instructions and comments provided within the QMS are considered the source of truth. These capabilities cut down on miscommunications and rework.

Frequently Asked Questions about QMS

What standards should an eQMS meet?

There are many guidelines for adopting a QMS. Some requirements, such as 21 CFR Part 11, are pertinent to all GxP systems. Below, we've listed standards that are set by health authorities/regulatory bodies and apply to life sciences organizations' eQMS (current at time of publication).

1. ISO 9001:2015 Quality Management Systems — Requirements is the leading standard for quality management system adoption. By following this guidance, life sciences organizations can comply with applicable regulations, identify risks/opportunities, and demonstrate conformity to specified QMS requirements. ISO 9001:2015 is applicable to any organization regardless of its type, size, products, and/or services.
2. ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes contains quality considerations for companies manufacturing medical devices. Adherence to ISO 13485 allows companies to demonstrate their ability to produce quality medical devices while mitigating safety and legal risks.
3. Current Good Manufacturing Practice (cGMP) Regulations are codified in the FDA's portion of the CFR. 21 CFR Part 210 pertains to the manufacturing processing, packing, or holding of drugs, whereas 21 CFR Part 211 provides guidance on finished pharmaceuticals.
4. Medical Device Good Manufacturing Practices are outlined in FDA 21 CFR Part 820 Quality System Regulation (QSR), which describes the cGMP requirements for design, manufacture, packaging, labeling, storage, installation, and use of medical devices in the United States.
5. EU GMP Annex 11 captures recommendations for any computerized system used in GMP activities, including guidance on risk management, personnel training, and third-party relations. EU GMP Annex 11 is the European counterpart to the FDA's 21 CFR, though there are differences.

As always, we recommend referring to the official and latest guidelines. Overall, your organization should ensure that prospective eQMS providers can demonstrate compliance with the applicable standards. Failure to meet industry requirements can cause lasting damage to your company's growth and reputation.

Which QMS vendors serve the life sciences industry?

All eQMS vendors generally provide reporting, workflow automation, and document version control. We've listed some of the most well-known software in the life sciences industry:

• eQMS (Qualio): Lean, streamlined platform that works well for companies on short implementation timelines and start-ups. Qualio offers modules for managing risk, training, change controls, and more.
• SureQMS (SureClinical): Suitable for small to medium-sized businesses, SureQMS not only covers standard quality processes, but also features an audit wizard and Smart Quality™ technology to proactively suggest corrective quality actions.
• QMS Xpress (Dot Compliance): Pre-configured, validated system built on Salesforce platform. The end-to-end platform allows for scalable growth.
• QMS (MasterControl): Cloud-based quality and compliance software that enables life sciences companies to control quality processes throughout the product development life cycle. Scalable for small businesses up to enterprise customers.
• Vault QMS (Veeva Systems): A cloud-based application, Vault QMS has been adopted by 100+ organizations and can be integrated with other modules in Veeva's Quality Suite (QualityDocs, Batch Release, and Vault Training). Learn more about our Veeva consulting and support capabilities. 

What should be considered when deciding on a QMS vendor?

When deciding among QMS vendors, gather the following information about your organization.

• Business Requirements: QMS solutions are not one-size-fits-all. Determine which features are nice-to-have, and which ones are critical for your organization. For example, if 21 CFR Part 11 complaint eSignatures and automated training assignments are must-haves, confirm that vendors will support those needs.
• Budget: QMS should be viewed as an investment. Licensing, professional services, and subscription fees may be continuing costs that should be compared against your department's budget. Ask your sales rep how pricing may change as you scale your organization.
• Timeline: Consider each vendor's proposed implementation timeline against the time constraints of your company. If you have a regulatory audit happening soon, narrow consideration down to vendors who can complete the project by that timeframe.
• Complexity: Adopting an eQMS is an investment not only of money, but also of time and effort. Is the system easy to use? Can users be quickly onboarded and instructed on conducting processes within the QMS? It is important to factor in your team's adaptability and appetite for change when implementing a particular solution.