CEBOS and Challenges in the Life Sciences Industry
Today’s life sciences organizations are under intense regulations and scrutiny given the public’s demand for safe products. For an organization to effectively meet these demands, all parts of the organization including the design, manufacture and distribution must meet the requirements imposed on it. One extremely important aspect of an organization’s ability to meet these requirements is to effectively and efficiently manage the quality management system (QMS) to ISO (e.g., 13485/14971, etc.), GxP and the multitude of FDA requirements (e.g., QSR Title 21 Part 820, 21 CFR Part 11, etc.). Given the enormity and complexity of complying with such requirements, it is common to design and implement systems that can quickly be implemented (i.e., spreadsheets, separate databases), but are inefficient or ineffective in the long-term.
That is where CEBOS comes in. For over 17 years and supported by hundreds of deployments, CEBOS’ MQ1 software has been there ensuring organizations have coverage that continually exceeds these ever-changing, evolving requirements while making the compliance process easy!
Life Sciences Industry Commitment & Vision
CEBOS designs and develops MQ1 directly for life sciences, including medical device, pharmaceutical, among others (please click here to view CEBOS’ Life Sciences Software Automation and Compliance Suite). This is done through a collaborative process with our life sciences customer base as well as our proactive involvement in understanding changes to the standards and regulations before they are adopted. This approach allows CEBOS to develop relevant life sciences compliance solutions that are easy to implement and innovative. At CEBOS, we recognize that continually innovating our products is essential to providing the best products in the marketplace, that’s why we have made it part of our mission statement!
Compliance & Automation
To be able to compete in the life sciences industry, compliance to recognized quality standards and governmental regulations such as ISO and FDA regulations is a requirement for doing business. CEBOS’ MQ1 software was born from this environment and created specifically to exceed such compliance requirements. Since these standards change over time, CEBOS has made it part of its charter to continually monitor the standards and update MQ1 to provide for an optimally, automated compliance solution. This is part of the value you can expect from CEBOS; now you can focus on your job, not worrying about staying on top of changing compliance requirements!
Automation is the return on investment you can also expect from MQ1. Whether it’s:
- Seamlessly sharing data across unique business processes (e.g., documentation control to training as change requests are implemented, auditing to corrective action for findings, drawings to control plans to inspection plans when engineering changes are made, etc.),
- Eliminating email, phone or in person time to complete a task or,
- Seamlessly sharing data with other systems
MQ1 has got you covered with a completely scalable, leveragable quality management system!