Opel Labs

BACKGROUND

Introduce your business and what you do there.

I’m the president and CEO of Northeast BioLabs. We do contract work for pharmaceutical biotech companies.

OPPORTUNITY / CHALLENGE

What challenge were you trying to address with Opel Labs?

We needed to hire someone for software validation.

SOLUTION

What was the scope of their involvement?

We worked with Opel Labs for multiple software validation, so we can be compliant with the 21 CFR Part 11 regulation.

What is the team composition?

We worked with a QA specialist and a Part 11 compliance specialist.

How did you come to work with Opel Labs?

We came across them through a referral.

What is the status of this engagement?

We worked together from August–October 2021.

RESULTS & FEEDBACK

What evidence can you share that demonstrates the impact of the engagement?

The quality of their work was great, as we didn’t really have to go back and forth with them in terms of the requirements. They came back to us, applied the changes, and retested the product, so it was a very smooth process.

How did Opel Labs perform from a project management standpoint?

They delivered within the timeframe and budget they specified and overall, it was a good collaboration.

What did you find most impressive about them?

We liked the fact that they were a small team, so it was easy to reach out to them. We communicated directly with our main points of contact and acquired information quickly.

Are there any areas they could improve?

We were quite satisfied with the work, so there’s nothing they could improve on.

Do you have any advice for potential customers?

I would say be as specific with the requirements as possible.