We make products reliable, scalable, and secure
Opel Labs is a SanDiego, California based full-service quality assurance (QA) and testing company. Our mission is to help businesses create zero defect and high-reliability products. As a pure-play testing company, we believe quality carries the importance of being independent. We offer consulting services and a full suite of manual and automated testing services. Our services cut across testing devices, software, mobile apps, web applications, and cloud solutions.
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Software Validation for Biotech Company
"We liked the fact that they were a small team, so it was easy to reach out to them."
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the review
A Clutch analyst personally interviewed this client over the phone. Below is an edited transcript.
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.
What challenge were you trying to address with Opel Labs?
We needed to hire someone for software validation.
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.
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.
Opel Labs was able to successfully deliver on their tasks and requirements, much to the delight of the internal stakeholders. The team was highly proactive and remained in tune with their timelines and budget.