Implementing quality management systems in regulatory environments is indispensable for smooth operability. While these systems were traditionally operated using paper-based techniques, lost documentation, missing signatures, and lack of document control eventually led to the advent of the electronic quality management system (eQMS). An eQMS system helps businesses solve these challenges by automating quality management operations, making tracking and managing data, documents, and workflows easier.
The objective is straightforward: to reduce costs and time to market by automating quality management procedures that companies utilize to ensure Compliance and improve product quality. These systems also contribute to corrective action, audit executions, and more elements at the forefront of any organization’s efforts to attain Compliance and operational excellence in this digital age.
Suppose your company prioritizes quality control, Compliance, and efficient management of processes. In that case, you are more than likely to face a need to employ an electronic quality management system that supports your unique business objectives sooner rather than later. However, choosing the right eQMS for your organization can be challenging. To help you select the right electronic quality management system, we at Akitra have curated this blog. This article answers the five most frequently asked questions about eQMSs.
What is an eQMS?
An electronic quality management system, or eQMS, is a software program that helps businesses manage and preserve quality control procedures. It is also sometimes referred to as an enterprise quality management system, and its main objective is to guarantee that a company complies with legal and industry standards while raising the caliber of its output.
An eQMS enables cross-functional communication and cooperation on crucial processes made possible by centralizing, standardizing, and streamlining quality content and procedures. A thorough electronic quality management system incorporates features like GxP, Risk, Compliance, and auditing. An eQMS further integrates with other systems, such as Enterprise Resource Planning (ERP) and Supply Change Management (SCM), to prevent data silos and optimize workflows programmatically.
Five Most Frequently-Asked Questions about Electronic Quality Management Systems
- When is the Right Time To Adopt an eQMS?
It would help if you had created or developed a QMS before investing in an eQMS solution. When you have a quality management system established or are in the process of creating one, you can consider using an eQMS to automate and streamline your processes if you:
- use a variety of software programs, paper documents, and spreadsheets to manage your quality processes;
- have to strengthen teamwork and communication within your quality department;
- need to automate and simplify your QMS procedures to increase productivity and cut expenses;
- have to increase adherence to rules and guidelines;
- need improved visibility into your high-quality data; and,
- require a versatile and adaptable solution to handle the expansion of your business.
If any of the aforementioned situations resonate with you, it is time to start looking for an eQMS solution that will enable you to advance your quality management.
- What Does an eQMS System Do?
An electronic QMS simplifies by automating quality management procedures like document control, change control, non-conformance, Corrective Action Preventive Action (CAPA), audits, training, supplier management, and more. Documents and data about quality are often kept in a central repository by an eQMS, which authorized individuals can access and edit from anywhere globally.
An eQMS can be used by several departments within an organization to work together on quality-related tasks, ensuring that everyone agrees and pursues the same objective. Identifying which quality processes will be handled by the system is crucial for establishing your needs for the new eQMS. Will you take Standard Operating Procedure (SOP) alone, or will you also handle audits, CAPAs, and incidents? You can choose the right electronic quality management system by considering all possible requirements beforehand.
- What are the Benefits of Using an eQMS?
Here are some of the benefits of using an electronic quality management system (eQMS):
- Increased Profitability: eQMSs confirm that every product satisfies the necessary quality standards and complies with all applicable local, state, and federal safety rules. When clients are assured of receiving high-quality, safe products, they are more inclined to make repeat purchases and even recommend your business to their friends.
- Higher Compliance: eQMSs ensure adherence to the dynamic regulatory environment.
- Elevated Productivity: eQMSs can improve worker productivity by assigning specific responsibilities or duties to staff members promptly, allowing them to start working immediately.
- Document Control: eQMSs serve as virtual filing cabinets for your files, reports, and documents, allowing you to quickly browse through them and organize them to suit your needs.
- Seamless Integrations: eQMSs combine seamlessly with other CRM, SCP, and PLM technologies to form a unified system that optimizes operations and delivers precise data for Compliance.
- Reduced Risks: eQMSs can monitor systems for impending risks and influence improved judgment and decision-making. They track Productivity, product quality, and other important key performance indicators (KPIs) so you can promptly assess opportunities and decide what is best for your business in the long run.
- How are eQMSs Designed and Validated?
Electronic quality management systems (eQMSs) are customizable or out-of-the-box pre-configured solutions. The former can be amended to suit company specifications, while the latter has some pre-existing processes that your business needs to tailor its requirements around.
An eQMS is most commonly designed following the guidelines of one of the standards developed by the International Standards Organization (ISO). Many organizations use ISO 9001 as the basis to create their own QMS program. Other ISO standards related to QMS include ISO 13485 (QMS for medical devices), ISO 14971 (risk management framework for medical devices), and ISO 9004 (standard for continuous improvement meant for achieving sustained success).
When validating an eQMS, you can run test scripts and ensure everything is functioning as intended. The Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes are followed throughout the entire validation process, which is further documented for maintaining records.
- How Much Does an eQMS Cost?
Electronic quality management systems (eQMSs) come at various price points. There is no universal solution.
As a result, many eQMS suppliers customize their pricing structures to meet every customer’s unique requirements. The primary cost components of an eQMS are as follows:
Quantity of Users: refers to the number of users requiring access to the system. As the number of users rises, the price per user typically falls.
Quantity of Modules: refers to the range of modules supporting various QMS processes. Suppliers typically base their prices on the modules you require.
Security, Risk Management, Compliance, and Quality Management with Akitra!
Establishing trust is a crucial competitive differentiator when courting new SaaS businesses in today’s era of data breaches and compromised privacy. Customers and partners want assurances that their organizations are doing everything possible to prevent disclosing sensitive data and putting them at risk, and compliance certification fills that need.
Akitra offers an industry-leading, AI-powered Compliance Automation platform for SaaS companies. Using automated evidence collection and continuous monitoring, together with a full suite of customizable policies and controls as a compliance foundation, our compliance automation platform and services help our customers become compliance-ready for security standards like ISO 13485 that specifically needs the implementation of a Quality Management System, and other regulatory frameworks, such as SOC 1, SOC 2, HIPAA, GDPR, PCI DSS, ISO 27001, ISO 27701, ISO 27017, ISO 27018, ISO 9001, ISO 13485, NIST CSF, NIST 800-53, NIST 800-171, FedRAMP, CCPA, CMMC, SOX ITGC, Australian ISM and ACSC’s Essential Eight and more. In addition, companies can use Akitra’s Risk Management product for overall risk management using quantitative methodologies such as Factorial Analysis of Information Risks (FAIR) and qualitative methods, including NIST-based for your company, Vulnerability Assessment and Pen Testing services, Trust Center, and AI-based Automated Questionnaire Response product to streamline and expedite security questionnaire response processes, delivering huge cost savings. Our compliance and security experts will provide customized guidance to navigate the end-to-end compliance process confidently. Akitra Academy provides easy-to-learn short video courses on security, compliance, and related topics of immense significance for today’s fast-growing companies.
The benefits of our solution include enormous savings in time, human resources, and cost savings, including discounted audit fees with our audit firm partners. Customers achieve compliance certification fast and cost-effectively, stay continuously compliant as they grow, and can become certified under additional frameworks using a single compliance automation platform.
Build customer trust. Choose Akitra TODAY!
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