Kneat: Life Sciences Validation Software Workflow

Kneat is an Irish software company listed in Canada with a CAD $600m market cap. The company has grown ARR over 40% per year over the past 5 years with current NRR of over 130%. The company is cash flow break even and seems to have a dominant position in a vertical software market. 

Kneat’s SaaS platform, Kneat Gx, helps life sciences companies digitize their validation lifecycle management workflows. This research piece walks through the company’s offering, its stickiness, and got-to-market sales process.

Validation

The life sciences industry is highly regulated where companies need to constantly test, document and prove that products and processes meet quality and safety standards. Validation is a subset of Quality where documentation is created and maintained for audits. The FDA 21 CFR Part 211 lays out the expectations for quality under GMP. For example, here is how the regulation mandates qualification and validation processes for all kinds of equipment:

“Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.” - FDA CFR 21 Part 211.68 

Records needs to be held for at least a year after the expiration date and be readily available for inspection:

“Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the batch.” - FDA CFR 21 Part 211.180

The Pharmaceutical Inspection Convention, PIC/S, which harmonizes inspection practices across regulatory bodies, lays out guidelines for inspectors. It requires the pharma company to show the documentation listed below and more.

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