Question to Ask before buying QMS Software

1. 7 Questions to Ask When Buying an eQMS for Your Enterprise

2. Overview Selecting the appropriate eQMS software is vital for the prosperity of your organization Question & Answers Determining the correct choice requires thorough planning and asking the appropriate questions about Ample Logic Explore about the company, know about the industries we serve and book a free demo

3. 1 Overview A modern cloud-based eQMS can signifjcantly boost your productivity as a quality leader. It enables you to closely monitor key quality metrics throughout the entire lifecycle of your product or service. Integrating a highly efgective eQMS with your enterprise's ERP and CRM systems helps streamline automation. By digitally transforming your ERP, Customer, and Quality processes, you improve workfmow effjciency and ensure data takes center stage in your decision-making process. Maintaining a high level of quality control across your organization can give your business a competitive edge. The purpose of creating this Buyer's Guide is to empower quality leaders with the right questions to ask when considering an eQMS purchase. However, it's important to note that every enterprise has unique internal dynamics. Sector-specifjc regulatory and compliance requirements vary. Therefore, selecting a customizable and fmexible eQMS solution that seamlessly integrates with your current workfmow and processes is crucial.

4. 2 What do I want to achieve? 1 When embarking on the journey of fjnding the perfect Electronic Quality Management Software (eQMS), it is crucial to establish your objectives and understand your long-term business goals. Requirements eQMS Manual SharePoint Visibility Audit trail Scalable Lifetime cost of ownership Effjciency Accessibility Functionality Reporting capabilities Confjgurable Low initial cost Maintenance cost Speed of implementation Ownership Ability to manage change Compliance

5. 3 This guide will help you navigate the process, ensuring you make informed decisions aligning with your organization's needs. Finding the right eQMS software vendor starts by specifying your needs and long-term business objectives. Therefore, the below guide will help you navigate the process, ensuring you make informed decisions aligning with your organization's needs. Identifying Business Objectives Significance of Defining Needs Before diving into the vendor selection process, clearly defjne what you want to achieve with eQMS software. Consider your organization's specifjc pain points, challenges, and desired outcomes. By understanding your objectives, you can efgectively evaluate potential vendors and fjnd a solution that addresses your unique requirements. Defjning your needs is crucial to selecting the most suitable eQMS vendor. Review your needs thoroughly, considering compliance obligations, operational processes, and desired functionalities. By clearly articulating your needs, you can avoid potential pitfalls and select a vendor that aligns with your organization's goals. Common Drivers for eQMS Procurement Several common drivers lead organizations to seek eQMS software. These may include a lack of visibility into decision-making processes, a reactive culture, incidents leading to high expenses or damaged reputation, high costs associated with poor quality, failed audits, absence of a formal management system, high growth, new product launches, compliance silos, lack of engagement with the management system, and outdated legacy systems. Identifying the drivers relevant to your organization will guide your procurement project.

6. 4 Selecting the Right eQMS Vendor Creating a User Requirements Specification (URS) With a well-defjned set of objectives and a URS, you can efgectively evaluate potential eQMS vendors. Consider factors such as the vendor's reputation, experience, product capabilities, scalability, customer support, implementation process, and cost. You can make an informed decision that aligns with your business goals by conducting thorough assessments. Creating a User Requirements Specifjcation (URS) is recommended to centralize and document your operational needs efgectively. A URS is a comprehensive document outlining your specifjc requirements for eQMS software. It acts as a reference point during vendor evaluations, enabling you to ensure that the chosen solution meets your business needs. The Benefits of a URS A URS ofgers several advantages during the vendor selection process. It helps you establish clear evaluation criteria, ensures consistency in assessing difgerent vendors, facilitates efgective communication with potential vendors, and enhances the likelihood of fjnding the best-suited eQMS solution for your organization's needs. Highlights Selecting the right eQMS software vendor is a critical step in optimizing your organization's quality management processes. By clearly defining your objectives, documenting your needs through a URS, and conducting thorough evaluations, you increase your chances of finding an eQMS solution that drives success and meets your long-term business objectives. Remember, each organization's journey toward finding the perfect eQMS vendor is unique. Stay focused on your goals, conduct comprehensive evaluations, and choose a vendor that provides the desired features and becomes a strategic partner in your quality management journey.

7. 5 Does it meet my industry standards? 2 Beginning your quest for eQMS software can feel like a daunting task. Numerous vendors populate the quality management category on well- known third-party review platforms, making it challenging to choose the right solution. To simplify the process, it's essential to prioritize systems that ofger the quickest time to value for your organization. When selecting a QMS software and narrowing down vendors, you have two primary options available: Failure to meet regulatory standards can expose your organization to severe penalties, fjnes, and recalls. While modifying generic eQMS software to meet FDA or ISO requirements is possible. However, this approach typically demands substantial resources and can raise regulatory risks. Each signifjcant update to the system would necessitate revalidation of the eQMS. 1. Select an eQMS designed for your specific industry demands  2. Choose a generic eQMS system and attempt to retrofit your GxP and regulatory needs  Industry-specifjc QMS software supplies a signifjcant advantage, especially in highly regulated sectors like the life sciences industry. These specialized eQMS solutions are designed following FDA, ISO, and other regulatory requirements, ofgering added value to life science organizations through built-in compliance and streamlined validation processes. Compliance with FDA regulations is vital for manufacturing and selling devices, drugs, or biologics in the United States, while ISO compliance is critical for approval in non-US markets. Additionally, if your confjgurations involve custom code, signifjcant long-term costs may be associated with maintaining this code and any custom integrations. The most effjcient path, therefore, is to opt for an eQMS built specifjcally for organizations in the life sciences industry.

8. 6 Such a solution should ofger automated quality workfmows for monitoring quality, managing complaints, and handling Corrective and Preventive Actions (CAPAs) to meet FDA and ISO requirements. Providing built-in tools for compliance should efgectively reduce your organization's regulatory risks. Furthermore, a specialized eQMS should go beyond mere compliance and enable your organization to become truly quality-driven, delivering tangible value and allowing you to operate in constant audit readiness. Highlights The most efficient path, therefore, is to opt for an eQMS built specifically for organizations in the life sciences industry. Such a solution should offer automated quality workflows for monitoring quality, managing complaints, and handling Corrective and Preventive Actions (CAPAs) to meet FDA and ISO requirements. Providing built-in tools for compliance should effectively reduce your organization's regulatory risks. Furthermore, a specialized eQMS should go beyond mere compliance and enable your organization to become truly quality-driven, delivering tangible value and allowing you to operate in constant audit readiness.

9. 7 Can the eQMS integrate with my current ERP and CRM systems? 3 An efgective eQMS should be designed to seamlessly integrate with the organization's existing ERP and CRM systems, enabling the automation of quality and compliance processes throughout the organization. This integration encompasses internal workfmows, supplier management, logistics, and customer-centric departments. By establishing connections between key processes, an eQMS is a centralized repository of quality data, becoming the single source of truth. This unifjed view enables informed decision-making based on factual information. Furthermore, this data is accessible to all relevant stakeholders in real-time, promoting transparency and collaboration. A robust eQMS should also provide dashboards and reports for predictive and proactive analytics. These tools enable the capture of trends and the development of strategies for future growth. Quality and compliance's future revolves around data- driven practices, so the essence of quality analytics cannot be overstated.

10. 8 A next-generation quality system facilitates the identifjcation of trends and patterns by leveraging enterprise-wide quality data. Achieving such enterprise-wide data visibility demands seamless integration between the eQMS and ERP/CRM systems, regardless of whether the organization's ERP is Oracle, SAP, Rootstock, or any other system. This integration can be achieved through the use of REST API. The key questions you need to answers to at this stage are: ?? How easy is integrating the eQMS, we’re evaluating with our current ERP and CRM?? ?? Does the vendor provide support for integration with our systems? ??  What is the expected timeline for completing the integration process? ?? What security measures are in place to safeguard our data and systems during the integration process? Highlights A well-designed eQMS should integrate with the organization's ERP and CRM systems to enable automation, provide a unified view of quality data, support data-driven decision-making, and facilitate predictive analytics. Seamless integration between the eQMS and ERP/CRM systems is crucial for achieving comprehensive enterprise-wide data visibility and harnessing the power of quality analytics.

11. 9 Are onboarding services included? 4 Difgerent vendors have varying approaches to onboarding services for new clients. Some may require the purchase of onboarding services, while others ofger it as an optional value-added service. Additionally, some vendors provide limited support to new customers. In general, onboarding services are highly valuable for organizations adopting eQMS software. Expert onboarding services can ofger comprehensive support throughout the adoption process, including software setup, migration, and training. By leveraging these services, your organization can expedite the transition to the new software and ensure readiness for success. The guidance and support experts provide during the onboarding process help mitigate risks and challenges associated with implementation. Considering each vendor's specifjc onboarding services and evaluating their alignment with your organization's needs and goals is essential. Efgective onboarding can signifjcantly reduce the time it takes to go live with the new software and ensure a smoother transition. Ultimately, investing in expert onboarding services can contribute to the successful implementation and adoption of the eQMS software, maximizing the benefjts for your organization.

12. 10 When considering vendor onboarding services, it is vital to note that the quality of these services can vary greatly. It is not solely about the cost but rather about assessing multiple factors. One crucial factor is the expertise of the onboarding stafg employed by the vendor. Determine whether they possess the necessary knowledge and experience to guide your organization through the onboarding process efgectively. Additionally, it is benefjcial to inquire about the availability of a dedicated account representative who can provide personalized support. Highlights Choosing to partner with an organization that has a team with ample field experience in assisting companies similar to your own is essential. Their expertise in helping organizations swiftly transition to a new eQMS can significantly contribute to a successful onboarding process. Selecting a vendor with a track record of effectively supporting similar organizations can increase the likelihood of a smooth and efficient transition to the new eQMS.

13. 11 Will my quality data be secure? 5 Ensuring the security, confjdentiality, and availability of your data is vital for the success of your organization. Therefore, it is essential to carefully evaluate the data policies of potential vendors to determine if they align with industry best practices for data security. When selecting a cloud vendor, they must have a team of data security experts with extensive industry experience. They should demonstrate a commitment to continuously evolving their business practices to address evolving requirements and threats in data security. In addition to expertise, data availability is a critical consideration. Partnering with a cloud- based vendor requires a highly reliable service your organization can trust. The software should incorporate high levels of redundancy and adhere to best practices to ensure uninterrupted operation, even in server failures or natural disasters. Evaluating uptime is an essential metric for data availability, and a vendor should ofger 99.999% uptime or better. Assess your vendor's data backup and business continuity policies. Ideally, a cloud vendor should perform multiple system backups daily and store them remotely.

14. 12 For additional data security measures, inquire about your vendor's encryption practices. It is advisable to prioritize vendors that ofger 128-bit SSL encryption for data in transit and 256-bit AES encryption for data at rest. These encryption standards help protect your data from unauthorized access by enhancing security against potential threats and hackers. By thoroughly evaluating a vendor's data policies and practices, you can ensure that your data is treated with the utmost care and protection. As a result, it will provide you with the peace of mind that your sensitive information remains secure, confjdential, and available when partnering with the chosen vendor.

15. 11 Cloud vs. Local Storage- What works better for an eQMS? 6 The table below outlines the difgerences between cloud and local storage options. It is worth noting that the industry is progressively moving towards next-generation software designed for the cloud, making a cloud-based system highly recommended. However, evaluating this decision based on your organization's specifjc needs and circumstances is crucial. Cloud Storage System Local Storage System 1. Greater IT infrastructure requirements 1. Scalability and fmexibility 2. Lower upfront costs 2. Higher upfront costs 3. Easy remote access 3. Limited remote accessibility 4. Compliance with data residency regulations 4. Data security concerns 5. Potential delays for software updates 5. Automatic software updates 6. Dependency on internet 6. Complete control over data 7. Limited customization options 7. Enhanced customization

16. 12 Although cloud-based systems ofger scalability, fmexibility, lower upfront costs, and ease of remote access, they also involve reliance on internet connectivity and raise data security concerns. On the other hand, local storage systems grant complete control over data, enhanced customization options, potential faster response times, and compliance with data residency regulations. However, they often demand higher upfront costs, increased IT infrastructure requirements, potential delays for software updates, and limited remote accessibility. Considering the shift towards next-generation cloud software, a cloud-based system is recommended. However, assessing your organization's specifjc requirements and priorities is vital before making a fjnal decision. Evaluating factors such as data security, customization needs, costs, and accessibility will enable you to determine which option aligns best with your organization's goals and constraints. Highlights Gaining a comprehensive understanding of the pros and cons of both systems is essential, and it is recommended to involve the CIO office in this evaluation. Given the rapid pace of technological advancements, an ideal solution would be a next-generation eQMS that is purpose-built on an actual cloud infrastructure. However, it is crucial to assess the suitability of this solution in your specific context, considering factors such as data control and infrastructure requirements. Additionally, cost considerations play a significant role in the decision-making process.

17. 11 How long does it take to implement an eQMS? 7 The timeframe needed for implementing an eQMS can vary depending on factors such as the size of your organization, the chosen features, demanded integrations, and existing systems and processes. Finding an ideal partner who can provide an estimate based on assessing your requirements, current systems, and the efgort needed for migration or integration to a new system is critical. It is important to avoid setting overly ambitious timelines, which can lead to potential issues. Accurately estimating the time and resources necessary for implementation and understanding the approach of prospective vendors is just as vital as the software itself. However, based on the size and scope of your organization, a well-developed eQMS software following best practices can generally take between 4 to 18 months for full deployment. You may be interested in two or three options when considering the software. 

18. 12 To make an informed decision, evaluating their ability to deliver a high-quality onboarding and implementation experience is important. Inquire whether they have implemented eQMS software for organizations with similar requirements and if they are familiar with integrating with your organization's ERP system.  Lastly, the cost of implementation and support, project timelines, and the experience of the channel partner leading the implementation process. Highlights Exploring and understanding the onboarding and implementation process is essential during the demo phase. Take a deep dive into this aspect to gain valuable insights. Additionally, it is crucial to inquire about the eQMS provider's experience in implementing their solution for other organizations with similar requirements. You can assess their expertise and track record in delivering successful implementations.

19. 13 About AmpleLogic AmpleLogic, established in 2010, is a prominent Low Code No Code (LCNC) Solutions provider. With a track record of 18+ successful product developments, including eQMS, LMS, DMS, and more, AmpleLogic has served over 100 pharma companies worldwide. Their fmagship product, Enterprise Automation, is a renowned GMP Quality Management System designed for multiple industries. AmpleLogic has established strong partnerships with leading pharmaceutical companies like Biocon, TEVA, Cipla, and others. It also impacts the semiconductor industry with clients such as ASE and ISE for their MES and Enterprise Automation needs. Moreover, the LCNC Software Development Platform creates solutions for multiple industries. Pharmaceutical Industries Food and Beverage Life Sciences Therapeutic Industries Cannabis Biotechnology

20. Looking for the best eQMS software? Now schedule a FREE DEMO with Amplelogic! click here for demo C Wing, 2nd Floor, Melange Towers, Huda Techno Enclave Rd, Patrika Nagar, HITEC City, Hyderabad, Telangana 500081 www.amplelogic.com info@amplelogic.com +91 40 6908 3300