Guest Author: Ron Schmitz, President and CEO of Grand Avenue Software
Are you struggling to support your evolving business needs by tracking quality information and processes in spreadsheets?
With an increasingly virtual work environment, changes in industry regulations, and the need to scale your business for growth, quality system software might be the solution your medical device company needs to meet your quality goals.
In addition to preparing your organization for notified body and internal audits, quality system software can automate and enhance essential quality assurance and regulatory compliance functions, including:
- Document control
- Training management
- Supplier evaluation and performance
- CAPA (Corrective and Preventive Action) oversight
- Complaint handling
- Design controls
- Equipment management
- Nonconforming materials
Beyond aiding compliance with current regulations and realizing short-term business objectives, quality system software, when implemented effectively, also streamlines operations for increased efficiencies and cost savings across your organization.
When selecting quality system software, partnering with experts who have experience implementing it in the real-world reduces the time it takes for your organization to realize its benefits.
Finding a trusted partner is especially critical for med tech startups and small medical device manufacturers operating on a shoestring budget with a small staff who may lack the expertise required for effective implementation.
Continue reading to better understand the value of implementing quality system software with a trusted partner to meet your quality and regulatory compliance goals.
Managing Information and Suppliers in the Virtual Workplace
Suppliers continue to take on more and more responsibility for medical device companies. And, COVID-19 has pushed all personnel, whether employees or those of important partners, to remote work locations. Quality systems and processes need to work effectively across company boundaries to include critical resources wherever they may be working. Quality system software helps optimize this distributed work environment.
In response to the expanded role of suppliers and partners, the 2016 revision to ISO 13485 placed an increased emphasis on supplier quality management. Medical device manufacturers must monitor, evaluate, and re-evaluate suppliers to maintain ISO 13485 compliance. An automated quality software system with supplier management features helps ensure you’re meeting your compliance requirements.
How Quality System Software Enables Growth
Maintaining your organization’s critical documents for quality assurance and regulatory compliance in Excel spreadsheets hinders your company’s growth trajectory.
Quality system software not only automates the manual work of maintaining spreadsheets but also streamlines projects and results in more efficient processes throughout the product life-cycle. It also ensures your team members are working with the most up-to-date information, avoiding errors that may occur from using out-of-date data.
Electronic records are easy and inexpensive to store and can be accessed remotely by team members spread across the globe. Further, your organization can achieve and maintain compliance without adding significant staffing resources or workload.
Implementing quality system software improves efficiencies, reduces waste, and helps you meet quality and compliance objectives. This improves the bottom line, shortens your go-to-market timeline, and creates an environment ripe for growth and expansion.
Reduce Your Go-Live Timeline with a Trusted Implementation Partner
For many medical device manufacturers, identifying the need for a quality system software solution is only the first step. It’s the effective implementation of it within existing processes and procedures that is an equally important challenge.
Finding a trusted partner who understands your business objectives for selecting the quality system software solution and has the experience implementing and validating it is critical to your success.
A consultant who is knowledgeable in the software’s real-world application can quickly train your team and develop a plan to integrate the solution into your organization’s existing standard operating procedures (SOPs).
From a timeline perspective, a trained consultant can reduce the time it takes to start using a new quality system solution from several months to a few weeks.
Implementing a new quality system software solution under the guidance of a QA/RA consultant will increase the rate of adoption, which will, in turn, improve long-term operational efficiencies and lower overall business risk.
About Grand Avenue Software
Grand Avenue Software is a QA Consulting, Inc. preferred solutions partner. Their simple, out-of-the-box quality system software is ideal for med tech startups and small-to-medium sized medical device manufacturers.
Located in Minneapolis/St. Paul, Grand Avenue Software offers integrated solutions to automate and enhance a company’s quality and regulatory compliance processes.