Who it’s for

For any organisation that has to prove its systems are fit for use.

dAInta is built for teams that validate computerised systems, equipment, utilities and software, and need to do it properly without an enterprise budget or a large validation department.

Pharma and biotech scale-ups

Growing companies moving into GMP manufacturing or clinical supply.

The challenge

You need to validate laboratory, manufacturing and quality systems, but you do not have a large validation team, and enterprise validation platforms are priced and scoped for global pharma.

How dAInta helps

  • Find gaps in your URS before vendors build or configure
  • See how each vendor design covers your requirements, with evidence
  • Apply a risk-based approach so effort goes where it matters

Medical device companies

Device manufacturers validating production equipment, software and quality systems.

The challenge

Software and equipment validation competes for the same engineering time as product development, and audit findings on validation records are costly.

How dAInta helps

  • Consistent, structured validation records
  • Traceability from requirement to evidence, ready for audit
  • Risk-based testing aligned with FDA CSA

CDMOs and CROs

Service organisations validating systems and equipment across many client projects.

The challenge

Each client project restarts the documentation cycle, quality varies by author, and validation timelines hold up client start dates.

How dAInta helps

  • One standard of output, whoever writes it
  • Leverage FAT and SAT results into qualification instead of retesting
  • Faster validation, so client projects start sooner

Equipment and system suppliers

Suppliers delivering equipment, automation and software into regulated sites.

The challenge

Customers expect a validation package with every delivery, and preparing IQ/OQ documentation for each order eats into margin.

How dAInta helps

  • Show customers exactly how your design covers their URS
  • Build FAT and SAT protocols from your design specifications
  • Stand out with a stronger, faster validation package

Join the early access programme

We are working with a small group of Life Sciences teams to shape the first commercial release. Early access customers get preferential terms and a direct line to the product team.