Our insight from the industry

"Can you build us an app?" "What does it cost?" "1.5 million kroner." "What do we get for the money?" This is a conversation we often have at Hyperbolic. And the right answer is not "An app with these features." The right answer is "Value that exceeds the investment."

Agile works great with a small team. Five developers, one product owner, daily stand-ups, two-week sprints. Communication is easy, decisions are quick, deployment goes smoothly. But then the company grows. Suddenly, you have 20 developers. Then 50. And the agile process that worked so well starts to crack. Stand-ups take 45 minutes. Teams step on each other's toes. Releases become chaotic.

At Hyperbolic, we work with cybersecurity in both the pharmaceutical industry and general software development. Regulated industries face unique challenges: security must be balanced with compliance requirements, legacy systems are often vulnerable, and the consequences of breaches can be catastrophic.

21 CFR Part 11 is the FDA's regulation of electronic records and electronic signatures. It was issued in 1997 - an eternity in technology years - but is still fully valid and actively enforced. Any pharmaceutical company operating in the U.S. market must comply with Part 11 when using electronic systems for GxP activities. However, the rules are written in broad, often vague language. What does "secure, computer-generated, time-stamped audit trail" mean exactly in practice?

Pharmaceutical companies generate enormous amounts of data: production data, quality data, clinical trial results, supply chain metrics, financial performance. But data alone does not create value. It is the insights that drive decisions.

Paper-based batch records are still the norm in many pharmaceutical production facilities. However, paper is inefficient, prone to errors, and resource-intensive. A single batch record can be 50-200 pages, require tens of thousands of manual data points, and take weeks to review.

"Can we even use cloud in a GxP environment?" That question we heard constantly 5-10 years ago at Hyperbolic. Today, the question is no longer whether, but how. Cloud is not just acceptable in pharma, it is becoming the standard. However, migration to the cloud in a regulated environment is fundamentally different from other industries. You cannot just "lift and shift" your systems and hope for the best. Compliance, data integrity, and validation must be handled carefully.

Equipment breakdown in a pharmaceutical production line is not just expensive; it can be potentially catastrophic. A critical freeze-dryer that goes down can ruin an entire batch valued at millions. An HVAC failure in a cleanroom can compromise sterility.

Quality control in pharmaceutical production is critical, but also resource-intensive. Each tablet must be inspected, each batch verified, and every deviation investigated. Can AI take over some of this work? And if so, when is it safe and regulatory acceptable?

Generative AI has revolutionized many industries in the past year. However, in the pharma world, where we at Hyperbolic have significant experience, enthusiasm is often mixed with concern. Can we use ChatGPT to write SOPs? Can we generate report text with AI? What about confidential data?

"Can we even use AI in a GxP environment?" This is a question we often encounter at Hyperbolic when working with pharmaceutical and medicinal companies. The answer is yes, but it requires a fundamentally different approach to validation than traditional software.

"We want a chatbot that can handle 80% of our customer inquiries." It's a request we often hear at Hyperbolic. And it's understandable: AI-driven customer service assistants promise faster responses, lower costs, and 24/7 availability.