Ever wondered why some life sciences organizations effortlessly maintain high-quality processes while others struggle to keep up? The secret lies in their adoption of Electronic Quality Management Systems (eQMS).
The challenge of rising quality issues in the life sciences industry is a common dilemma and implementing an eQMS can help you face those challenges head on.
Selecting the right electronic Quality Management System (eQMS) isn’t just a technological decision; it’s a strategic move that can significantly influence your organization’s trajectory.
This article delves into the key steps and considerations necessary to choose QMS software that aligns perfectly with your company’s unique goals and operational requirements. Whether your focus is on regulatory compliance, efficiency enhancement, or elevating product quality, making an informed choice is crucial for driving enduring growth within the competitive life sciences sector.
What is an eQMS?
An eQMS is a software solution that ensures compliance with regulatory guidelines. It supports the cross-distribution of data across the value chain via a communications platform that allows collaboration between various levels of the chain. Most current eQMS platforms are web-based and model their approach on core business process management methods.
Market leaders in eQMS create software that adopts a broad set of functionalities related to quality management. This includes the range of GxP, quality risk, regulatory compliance, and auditing functionalities. Quality, rather than standing alone and disjointed, therefore exhibits a closed-loop form that supports the inter-operation of the various other biotech, pharmaceutical, or medical device applications used by a life sciences company. Various applications required by the process are integrated within the system, sharing data that improves the efficiency of the workflow. The platform itself is often interoperable with other applications such as ERP and SCM.
Scilife provides a Smart electronic Quality Management Software designed with the unique needs of life sciences organizations in mind. You can discover more about our eQMS software here and get in touch with our team.
Reasons to undergo eQMS implementation
In today’s competitive market, fostering a culture of quality, compliance, and operational excellence is more critical than ever. Ensuring customer trust in product quality and safety is essential for sustained success and market reputation. A foundational step towards achieving operational excellence in life sciences is the implementation of a robust Quality Management System (QMS).
Integration of quality with company objectives
The primary objective of choosing an eQMS is to integrate quality seamlessly with the company’s overarching objectives. Instead of treating quality as a departmental concern, an effective eQMS ensures that quality-related values permeate every stage of production across global scales. By standardizing and integrating quality expectations throughout the enterprise, each department receives inputs meeting consistent quality standards, thereby facilitating high-quality outputs downstream.
Breaking down information silos and enhancing communication
A robust eQMS breaks down information silos by connecting data across departments. This connectivity fosters deeper communication and enhances the identification of pitfalls or errors, facilitating efficient remediation processes. Modern eQMS applications leverage mobile technology to enable seamless communication not only between departments but also involving stakeholders such as patients and customers in collaborative quality management processes.
Assurance of operational integrity and compliance
An eQMS provides assurance to users and regulatory bodies regarding the reliability and integrity of the enterprise’s operations. It ensures adherence to standards of completeness, attribution, disambiguation, and more. This is crucial for companies with decentralized operations or those outsourcing aspects of their business, as eQMS aids in content alignment, risk management, resource optimization, and internal communication. It also supports auditing and continual improvement processes to maintain competitive edge and regulatory compliance in industries like biotech, pharmaceuticals, and medical devices.
Recommended learning: Uncover the hidden costs of skipping an eQMS. Find out what they are and don’t let poor quality drain your budget.
Considerations for choosing the right eQMS
1. Assemble a cross-functional team
A successful eQMS implementation requires input and collaboration from various departments within your organization. Your team should be diverse and include representatives from the following key areas:
- Quality Management: Include quality managers from executive, corporate, plant, and laboratory levels.
- Compliance and Regulatory Affairs: Ensure representatives can address regulatory guidelines and compliance needs.
- Manufacturing Operations: Input from manufacturing is vital for operational alignment.
- Logistics: Include packaging and shipping stakeholders for end-to-end quality control.
- Sales and Finance: Align quality goals with business objectives.
Environmental Health and Safety (EHS): Ensure EHS compliance is integrated.
Educate the team on eQMS goals and charter
Once your team is assembled, it’s vital to educate them on the goals of the eQMS project. This involves:
- Understanding cross-functionality: The team should recognize the importance of cross-functional collaboration within the eQMS. They need to understand how different departments will interact with the system and the benefits of an integrated approach to quality management.
- Defining the eQMS charter: Clearly articulate the objectives, scope, and expected outcomes of the eQMS implementation. This ensures that everyone is aligned on the purpose and goals of the project. More on this in the next step.
2. Identify your eQMS needs
Before selecting an eQMS, it's essential to conduct a thorough assessment of your organization’s quality management needs and objectives.
Define specific quality processes and operations
Start by defining the specific quality processes and operations you intend to manage within the system. This could include controlled documents, audits, training programs, CAPAs (Corrective and Preventive Actions), and handling customer complaints. Understanding these needs is critical as it allows you to prioritize functionalities that are essential for improving operational efficiency, maintaining regulatory compliance, and mitigating quality-related risks.
Examples of functional priorities
For instance, if your organization frequently conducts audits to ensure adherence to regulatory standards, you’ll need an eQMS that supports robust audit management functionalities. Similarly, if managing and tracking CAPAs is crucial for continuous improvement initiatives, the eQMS should offer comprehensive capabilities for initiating, tracking, and verifying the effectiveness of corrective and preventive actions.
Consider a scalable eQMS
As your business evolves, scalability becomes a key consideration. Your chosen eQMS software should be capable of scaling with your organization’s growth, accommodating expansions in product lines, market presence, or regulatory requirements without compromising system performance or requiring extensive reconfiguration.
Evaluate regulatory compliance requirements
Additionally, companies should identify all relevant guidelines, quality standards, and regulations to which they must comply. These may include general guidelines for computerized systems effectiveness, like ISPE GAMP 5, and general QMS requirements, such as ISO 9001:2015. Specific requirements for medical device QMS, such as ISO 13485:2016, pharmaceutical QMS like ICH Q10, and medical laboratory competence standards such as ISO 15189:2022, among others, should also be considered.
Define quality goals
Clearly define your organization’s quality KPIs and goals. Determine what you aim to achieve through implementing an eQMS, whether it’s improving product safety, enhancing regulatory compliance, streamlining processes, increasing operational efficiency, or reducing quality-related risks. When considering your quality KPIs, ensure that they are specific, measurable, achievable, relevant, and time-bound. For example, you might want to reduce the number of non-conformances reported internally per quarter by x amount. Identifying these quality KPIs and goals will help you prioritize functionalities that are essential for achieving these objectives.
Recommended reading: Learn what elements and features make a good eQMS software.
3. Compile your list of eQMS vendors and submit requests
Begin by compiling a list of potential vendors and submitting Requests for Information (RFI) or Requests for Proposal (RFP). These documents should clearly outline your organization’s timeline and the custom pharmaceutical, biotech, or medical device services you require. Key considerations include:
- Selection criteria: Define criteria such as functionality, software cost, and usability of the interface. Determine whether certain technical features are mandatory, prioritized, or optional based on your operational needs.
- Build requirements: Specify whether the system should be hosted onsite, net-based, or cloud-based. Decide if it should be browser-specific or browser-agnostic to ensure compatibility with your existing IT infrastructure.
Analyze proposals
Next, analyze the proposals received from vendors, evaluating them against your enterprise’s quality management operations and the regulatory demands of your industry. Consider:
- Fit for QMS requirements: Assess how well each proposal meets your specific QMS requirements, including document control, change management, audit management, and training records.
- Interoperability: Gauge the system’s interoperability with other critical systems like CAPA (Corrective and Preventive Actions), ERP (Enterprise Resource Planning), CRM (Customer Relationship Management), and SPC (Statistical Process Control). Integration capabilities are crucial for seamless data exchange and operational efficiency.
- Security considerations: Ensure that the vendor’s security measures align with your organization’s needs. Biotech, pharmaceutical, and medical device industries require robust security protocols to protect sensitive data and comply with regulatory standards.
- Validation Process: Consider the requirements and costs associated with the validation process. Many vendors provide validation documentation and IT SOPs, but they may charge additional fees, or you might need to engage a third party for validation. Understand the validation needs for your eQMS and any potential hidden costs.
- User Support and Training: Assess the vendor’s support and training offerings to ensure a smooth implementation and ongoing usage. Look for comprehensive training programs, robust implementation support, ongoing customer services, vendor expertise, and scalable support to meet your future needs.
4. Book demos with eQMS vendors
Booking demonstrations with potential eQMS software vendors is a crucial step in the selection process, allowing your organization to gain an in-depth understanding of the software's capabilities.
Start by requesting detailed demonstrations from a shortlist of vendors, ensuring that each demo covers the specific functionalities and requirements your organization needs. These demonstrations provide an invaluable opportunity to observe the user interface, assess ease of use, and understand how the software handles critical quality management processes such as document control, audit management, and CAPA (Corrective and Preventive Actions). By seeing the software in action, you can better gauge whether it aligns with your operational workflows and technical needs, which is essential for smooth integration and user adoption.
Evaluating practical application
During the demos, pay close attention to how the eQMS addresses real-life use cases relevant to your industry. Request examples that reflect common challenges and processes within your sector, such as regulatory compliance, process improvements, and data management. For instance, if you're in the pharmaceutical industry, you might want to see how the system manages deviation processes or supports compliance with GMP standards. This hands-on approach helps you evaluate the practical application of the software and its ability to meet your specific needs, ensuring that the eQMS will effectively support your quality management goals and regulatory requirements.
Tailoring the eQMS to your needs
Additionally, assess the customization and configuration capabilities presented in the demonstrations. It is crucial to determine whether the eQMS can be tailored to fit your unique organizational requirements, including custom forms, workflows, and reporting tools. Consider whether the software offers pre-configured options for quicker deployment or if it requires significant setup and customization. Understanding these aspects during the demo will help you make an informed decision about the scalability and flexibility of the eQMS, ensuring it can adapt to your evolving needs and support long-term success in maintaining high-quality standards and regulatory compliance.
5. Evaluate an eQMS through trials and Freemium programs
Before making a commitment, take advantage of a free trial or a freemium program offered by eQMS software vendors. This trial period is a valuable opportunity to test the system’s performance, functionality, and usability in a real-world setting. By involving a selected group of users, you can gather practical feedback and identify any areas that may require adjustments. This hands-on evaluation allows you to ensure that the eQMS aligns with your organization’s unique requirements and regulatory standards, thereby facilitating a smoother implementation process and enhancing overall satisfaction with the final system.
6. Final decision: Choose your eQMS
After completing the demo and trial phases, carefully assess the vendor’s support and services. Evaluate how responsive and knowledgeable their customer support team is, and consider the level of assistance provided during implementation and ongoing use. Comprehensive training programs, timely customer support, and a genuine commitment to customer success are critical indicators of a reliable vendor.
Ultimately, your decision should align with your organization's specific requirements and objectives. Choose a QMS software provider that offers a complete and tailored solution, facilitating seamless quality management and compliance. The right choice will streamline operations, mitigate risks, and support long-term success.
BONUS resource: Considering the ROI of an eQMS is key; calculate your potential return with our user-friendly eQMS ROI calculator.
Scilife: more than an eQMS vendor
At Scilife, we empower individuals and organizations to transform quality into a powerful catalyst for value creation, making Smart Quality an integral part of their culture. We believe that when everyone embraces quality, extraordinary things happen!
By choosing Scilife’s Smart electronic quality management software you can eliminate up to 80% of complex quality assurance tasks, turning quality into your brightest asset. Our platform infuses integrity, clarity, and compliance into your workflows, ensuring that your operations are not only efficient but also adhere to the highest standards.
