With the turn of 2017 comes a lot of changes for the Life Science industry. ISO 13485:2016 and other regulatory updates mean that organizations must adapt to new ways of approaching quality management.
Here’s how a cloud-based Quality Management System (QMS) can help you stay ahead of the Life Sciences industry for compliance in 2017.
Obtain and Maintain an Audit-Ready State
Being part of an industry as heavily regulated as the Life Sciences means you need to be in a state of “audit readiness” at all times. This means you have the tools and the confidence to pass any FDA or GMP compliance audit at any given time.
Tools that can help you maintain an audit-ready state are:
- Document Control
- Reporting tools
- Risk-driven Corrective Action
These are the tools you need to comply with regulations and stay audit-ready throughout the new year. This allows you to stay ahead of the game rather than catching up to the rest of the pack when audit time rolls around.
Risk Management tools provide what you need to prioritize activity and improve overall quality. Utilizing a Risk Matrix lets you put a numerical value on the potential impact something may have on your organization. That way, you have a measurable guide for comparing different scenarios and a standard by which you can measure improvement.
Now you can start off this new year by making each decision with risk in mind. You can prioritize corrective actions based on risk and carry on with the processes that present the lowest level of risk to your organization.
Closed-Loop Corrective Actions
Corrective actions are most effective when they are systematic and complete. Closed-loop corrective actions follow the following steps:
- Investigation of root cause
- Creating and launching an action plan
- Resolving the issue
- Verifying the effectiveness of the corrective action
Using this process will eliminate repeat offenses of the same issue, which fosters overall improvement. It also frees up your time and resources to focus on the things that set your organization apart from the rest of the industry.
All in a Flexible Platform that Works for You
Having all of these features in a cloud-based solution is even more beneficial for your organization. Deploying software in a cloud environment saves IT implementation costs and provides greater flexibility than some other solutions.
Armed with these tools, you can set your Life Science organization up for success in 2017.