How to Choose the Best QMS for Life Science Manufacturers
There are many factors manufacturers have to take into consideration when evaluating a Quality Management Solution to fit their growing business needs. They have to define the “critical components,” the “must haves” and the “nice to haves” to be able to choose the best QMS. All while keeping in mind that compliance to regulations and global standards are non-negotiable, especially in the highly regulated life science and biotech industries. Here are key points to consider when selecting a QMS solution to support your company’s compliance and growth.
Identifying the best Quality Management Solution for your needs
From a business and growth stage perspective, you have to consider timing – how quickly do you need the QMS solution up and running – and budget – how much can you invest in the system now versus later?
From a quality management process perspective, define the quality processes you need from a QMS solution right away, like document management and training, and others that can possibly wait until a later date, such as complaints and supplier quality management.
Also consider the risks of implementing a home-grown QMS solution or even an on-prem QMS solution versus a cloud-based QMS solution that is off the shelf ready. Keep in mind there are hidden costs when rolling out cloud based QMS solutions that aren’t fully validated versus ones that are fully validated.
How Quality Management Solutions (QMS) meets your needs at any stage
Introducing everything you need in all-in-one QMS solutions
Dot Compliance’s out of the box, holistic, cloud-based QMS solutions are configured with best practices that meet FDA, ISO, and GxP regulations. They enable end-to-end quality management with comprehensive coverage of all core quality assurance processes:
- CAPA Management: Automate CAPA processes to safeguard your organization from regulatory risk
- Risk Management: Take a proactive and risk-based approach that minimizes the chances for undesired effects and drives continual improvement by predicting potential problems
- Deviation Management: Manage the entire deviation process in the QMS solution, from initiation and investigation, to review, approval and closure in compliance with CFR 21 Part 11
- Change Management: Easily manage change updates, including documents, products and equipment
- Document Management: Capture, track and store all your documents in one place
- Training Management: Manage end-to-end employee training from record management, course distribution and completion, and escalation
- Audit Management: Manage the end-to-end audit lifecycle quickly and precisely, simplifying the entire audit process
Quality Management Solutions by industry
Dot Compliance’s off the shelf QMS solutions are ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest regulatory requirements.
- Pharma & Biotech: Pharma and biotech companies rely on our quality management solutions to make real-time decisions with a proactive quality management approach
- Medical Device: Medical device manufacturers rely on our solutions for all core quality assurance processes, training, regulatory compliance, and document control
- Manufacturing: Best in class life science manufacturers leverage our QMS solutions for a completely digitized quality and compliance manufacturing and reporting process that spans across the entire supply chain