Interview With a Quality Expert

Bobbi Lilek

Bobbi works as a Quality Systems Director for a rapidly growing biotechnology company that utilizes the ENSUR software for both Document Control and Quality Management. In order to maintain her company’s policy of strict customer confidentiality, she has requested to have the name of her company withheld.

As a Director of Quality Systems in the biotech sphere, Bobbi knows the ins and outs of strict government regulations. She also knows how difficult these protocols can be to keep up with. In this interview, we discuss tips on staying in line with regulations, how Bobbi’s company manages audits, and she’ll even provide a few resources to help others keep up with the latest quality trends. Read on to learn more.

1) What is your title at your company?

Directory, Quality Systems

2) What does your company do?

We are a provider of instruments, reagents, and services for molecular profiling applications

3) What changes or new challenges are happening to quality assurance processes in your industry?

The biggest challenge currently is the EU MDR and IVDR regulations that are now in effect. These new regulations require much more focus on design documentation and post-market surveillance, not to mention changes to the quality management system.

4) Why is it important to include a process for formal documentation for quality control?

First of all, it is a requirement to have formal documentation. Secondly, it creates a standardized approach and consistent documentation across the board.

5) How, if at all, has using Document Control Software helped this process?

For me, the biggest advantage for Document Control software is the ability to use electronic signatures! We implemented our new system during 2020, during COVID, and it has provided huge benefits. Electronic signatures have enabled users to monitor status of approvals and provide visibility to who has yet to approve; saved time by not having to contact multiple people for approval status; saved a ton of time by not having to print, copy and file paper copies of documents!

6) Do you have experience working with quality audits? If so, what is the biggest challenge in preparing for an audit?

I have been involved with quality audits since 1997, both internal audits and external audits including supplier audits. The biggest challenge preparing for the audits is ensuring the audit plan is comprehensive.

7) Has Document Control Software helped with your audit process?

So far, not directly. We have not utilized our document control software for our audit process yet. However, we implemented the training module as part of our electronic document system, and this has enabled us to pull training records much more efficiently!!

8) In your experience, what is the key to ensuring your company is compliant with all laws, regulations and standards that are applicable to your area of responsibility?

Ensuring that all employees are aware of the regulations and standards is key. We have a new-hire onboarding process that includes an overview of what it means to work in a regulated industry, and how each employee is involved and contributes to compliance.

9) How do you keep up with the latest technologies and trends in quality?

Personally, I subscribe to many feeds and websites that provide frequent updates on the ever-changing landscape of regulations. I attend webinars and conferences to keep up to date on all the changes. MedDeviceOnline.com; Emergo.com; BSIgroup.com; praxislifesciences.com has really good free webinars on software validation and 21 CFR Part 11 compliance; RQM+.com has good free content on their website.

To learn how other life sciences companies have benefited from ENSUR, view our customer case studies below: