How QMS is a crucial part of regulatory compliance for Medical Device Startups!
For any startup developing a solution for the Healthcare or Life Sciences, implementing and maintaining an effective Quality Management System (QMS) is a crucial part of regulatory compliance.
It can be tempting to want to sidestep a QMS in early stages of development due to the costs and preserving funds, but a QMS is an inevitable step that the FDA (or any other regulatory body) will be looking for. Delaying implementing an electronic quality management system (eQMS) will make migrating to a system later on more challenging and thus more costly. Despite the initial costs, the right QMS will help you define and execute your strategy for your product development. An eQMS is able to manage an organization and can assist in proving your solution is ready for market!
The first step is to understand the importance of an eQMS from a startup perspective. This blog will show you how to start out of the gate strong, rather than dealing with data migration later.
Keeps your team documentation organized
As a startup, your team might not have the current knowledge or resources to document the correct information when starting to develop your solution. This is why having a set of standard operating procedures (SOPs) for your team will not only help you keep track of what needs to be done, but also make sure that everyone is working in accordance with the same standards.
Sierra QMS will help you manage crucial documentation like SOPs through an automated workflow that ensures accountability and consistency. The system will provide a series of templates that can be customized to fit your product’s requirements and timeline circumstances.
Provides a framework for Risk Management
So why is risk important at your company’s age? It is helpful for regulators to assess a company's compliance by providing transparency into its internal workings from the beginning!
For startups, risk has always been an important theme when developing a solution for the highly regulated space of Healthcare and Life Sciences, particularly because there often isn’t a quality team in place. Regulators are placing added emphasis on ensuring that risks throughout the device lifecycle can be managed properly and appropriately, which will help protect both patients as well as healthcare professionals from any potential harm caused by poorly designed or manufactured products.
An eQMS that is well-designed will have a built-in risk management system. This will allow different parts of the system to communicate with each other via interlinking tools for documentation and approvals. A risk management plan not only secures documentation throughout development but also timelines, analysis, estimation, and even reviews in a seamless manner for all stakeholders. The eQMS should allow your team to consistently manage detailed procedures to assess and prioritize risk.
Sierra QMS provides a framework to incorporate your risk management plan. You will be able to align your efforts based on risk prioritization. The best way to assess risk is by using a system that includes processes like document change control, CAPA, supplier control, and internal audits (like Sierra QMS!).
Contains tool for Supplier Management
Forming supplier partnerships is a key part of doing business, but it's not without its risks. When focusing on a plan for going to market, suppliers and vendors play an important role for your product's timeline. This is why it is important to have a process in place that helps with evaluation and screening of third-party suppliers. Having a high level of evaluation for suppliers or vendors can be difficult without the correct tool to give you oversight on important documentation like contracts, services, and timelines.
Establishing supplier controls can be a lot more efficient than you think. An eQMS will help you track and manage important records regarding your partnership with third-party vendors (suppliers, consultants, or contractors). This list of suppliers may grow throughout your product’s development lifecycle so you want your team to be prepared with the correct toolset.
Your team needs an integrated tool for supplier management to help audit your individual partnerships internally. Sierra QMS is a comprehensive solution that enables organizations to evaluate, track, report on, and rate suppliers. By tracking supplier performance, the system helps organizations identify risk and supplier issues early.
Tailoring an affordable solution
As some of the best business tools, quality management software solutions are comprehensive tool kits that will help you set objectives, analyze risks, check performance, and implement ideas to achieve the best results.
Considering a bootstrap approach for your quality system will be difficult for teams without a dedicated quality team. By opting to create your own quality management team with bits and pieces of multiple software, your team will find it difficult to have a single source of truth. Organizations using Google Suite or Confluence do not get the same value or organization required by regulatory bodies when developing your product for this space.
Adopting an eQMS in today’s industry can come at a hefty price! Despite it being a cheaper initial cost, choosing an out-of-the-box solution for your organization might prove to be more costly in the long run. This is because the lack of customization of modules and tools don’t match the criteria for your product’s compliance goals. Don’t forget the hidden data migration fees.
Sierra QMS is a more secure choice for startups and scale ups because it is tailored towards your team’s quality needs. A solution that is cloud-based and protected by AWS helping you cut costs from the start. Our experts have worked with multiple small to mid-sized companies implementing a lite QMS with only the necessary modules for your compliance journey.
Importance of lite QMS at the start
For those just getting started, choosing a more scalable and flexible eQMS could allow you to work at the basic level of risk management without sacrificing robustness. This will help you integrate the right tools/functionality at the right time keeping your quality management audit-ready.
There is no doubt that an out-of-the-box eQMS is a tempting choice, but the expense it represents and it's one-size-fits-all approach’ may create more obstacles for your team.
Sierra QMS is a more flexible option for organizations that may not have a quality team or fully developed quality roadmap for their product. Our experts understand the obstacles a growing company can face and that is why we work with you to implement a cost-efficient and compliant QMS solution to take you from ideation to regulatory submission.
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How Sierra QMS can help your teams
Sierra Labs is the perfect partner for any startup looking to implement an efficient eQMS that complies with global regulations. We can establish procedures for regulatory compliance tailored to the specific markets you’re interested in entering.
Sierra QMS has helped many Medical Device, Biotech, and Pharma companies implement proper regulatory management, documentation, and design controls. With our easy-to-use software, your team will effortlessly access and reference the materials to perform their role.
Sierra QMS is designed for organizations who are looking to market solutions for the Healthcare and Life Science spaces. It is built for engineering teams to operate with their preferred tool-sets while automating the compliance with QMS principles for global markets.
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