If quality management is lacking within your distributed life sciences company, the success of your organization is in jeopardy.
Without a quality management plan in place, serious regulatory fines and penalties will likely ensue. Unfortunately, your organization's inability to detect quality issues and product deviations can result in external nonconformance issues that come with regulatory risk, a loss of customer trust, and damage to your organization's reputation.
Fortunately, the right medical device software solutions can equip your organization with the tools needed to prevent regulatory compliance and quality issues. In fact, most regulatory bodies will already assume that your organization has already invested in a digital quality management system.
When paired with the right quality management system, your organization's quality management plan can deliver significant value to your organization and patients alike.
How to Build a Quality Management Plan for Distributed Life Sciences Companies: 5 Key Steps
What does it take to build the best quality management plan for your distributed life science company?
Your organization can reduce regulatory risk with a modern quality management plan. But what are the exact steps that you should follow to drive the biggest transformation in quality management?
Here are five key steps your organization needs to follow to accelerate quality management plan development and implementation.
1. Get Stakeholders Involved
A complete quality management plan requires buy-in across teams. As a best practice, consider allocating time to designate proper roles and responsibilities.
Additionally, when discussing company culture, it's a good idea to emphasize that a shift in mindset is required. Unfortunately, most distributed life science organizations fail to communicate the importance of a quality-driven culture.
As quality is adopted across groups, devote appropriate resources to on-going employee training and engagement. Unfortunately, quality cannot be instituted with a "set it and forget it" attitude. Instead, it requires lots of attention and on-going reorientation.
2. Select the Right Template
As you know, documentation is at the core of effective quality management. Your life science organization needs to carefully and thoroughly document quality by creating a quality manual, quality strategy, standard operating procedures, and a detailed record of on-going quality management activities.
It might sound overwhelming. But it doesn't have to be.
A quality management plan is a unique document that completely details how quality activities align with regulatory requirements and the broader business strategy. You can't skip any steps when it comes to quality management, but you can simplify the entire process by selecting the right "template."
In this scenario, distributed life science companies typically invest in quality management software to systemize quality management and regulatory compliance.
3. Set a Timeline
When building a quality management plan, you need to create a clear baseline for every deliverable. You also need to describe the methods of evaluating those deliverables against regulatory standards.
In most cases, quality managers asses quality criteria, metrics, preventative activities, control activities, and approval activities.
As such, an implementation and operational schedule are necessary. By setting an appropriate timeline, your distributed organization will be better equipped to meet project goals and order fulfillment.
RELATED READING: How to Shrink the FDA Medical Device Approval Timeline
Try organizing processes into small groups. By grouping related processes together, teams can work towards effective systemization.
For example, you might organize a small group around preventative activities. In this scenario, the group could work on establishing rigorous measures to proactively mitigate noncompliance.
This kind of systemization keeps teams working on a single focus and keeps the entire organization working toward broader quality management objectives.
5. Select the Right QMS
As an industry-leading quality management software provider, we've found that companies look for enterprise quality management software for one of several reasons. Regardless, selecting the best quality management software for your life science company is a critical component of any quality management plan.
We might be biased, but we know that we're not the only great option on the market.
Finding the right QMS starts with careful consideration of the following:
- Does it have an intuitive interface?
- Does it have a low learning curve?
- Is it easy to set up?
- How difficult is it to manage?
- Can it scale with you as you grow?
- Is it priced fairly?
Before making any final decisions, try a free product demo to find out how Qualio can help your company get to the next level.
RELATED READING: 5 Indispensable Features of Enterprise Quality Management Software
Kickstart Your Quality Management Plan
If the quality management plan is the framework that guides your organization to achieve its quality objectives, the quality management system is the vehicle by which the quality management plan is organized and delivered.
The most effective QMS implementations balance unique simplicity and customization. The QMS must align with your organization's objectives, industry, and compliance requirements. Simultaneously, every customization must provide a meaningful impact on your organization's quality culture.
To find the best quality management system for your distributed life science company, we recommend downloading our QMS buyer's guide. You'll learn the top questions to ask any QMS vendor before making a decision.