Summary
- Why Seal
- Seal has no fixed model of one kind of work. It is built from primitives: record types, the relationships between them, and the steps and checks that use them, which your own team composes into your process, with Neil able to prepare each change for approval. So one platform runs process development, the laboratory, manufacturing, batch release and the quality system, and each change becomes a new version, released once its selected tests pass, while earlier runs keep theirs. The processes, the equipment they use and the evidence that they are fit for use live on one platform, selected checks run when a change is prepared for review, and your team assesses each supplier release against its intended use.
- Results
- Moving from paper, Bioventix cut document admin time by 80%, and a customer audit commented positively on its electronic signatures and audit trails. “We have been delighted with the rigour and agility shown by Seal in providing Ingenza with a robust GxP system that fully supports our process development and biomanufacturing operations.” Ian Fotheringham MBE, CEO, Ingenza.
1What to check when choosing.
- Does the evidence live with the system it validates, or in a separate validation system?
- Do checks run when a change is prepared, or only at periodic revalidation?
- Is each release of supplier software assessed against your intended use?
- Does it follow a risk-based approach under GAMP 5 Second Edition and the FDA’s CSA guidance?
- Are protocols executed online, with failures, corrections and retests kept with the change?
Each product’s comparison sets out, with its sources, how it answers these and how Seal does.
References
- 1Official Information About Kneat Solutions, Kneat, updated 28 August 2026. https:/
/ kneat. com/ llm- info/ (read 5 November 2026) - 2About us, Kneat. https:/
/ kneat. com/ about- us/ (read 5 November 2026) - 3About ValGenesis, the Leader in Validation Digitalization, ValGenesis. https:/
/ www. valgenesis. com/ about (read 5 November 2026) - 4ValGenesis Launches Smart GxP™ as First AI-Enabled Platform to Unify Validation and Process Development, ValGenesis, 4 June 2025. https:/
/ www. valgenesis. com/ news/ valgenesis- launches- smart- gxp- as- first- ai- enabled- platform- to- unify- validation- and- process- development (read 5 November 2026) - 5About, Sware. https:/
/ www. sware. com/ about (read 5 November 2026) - 6BTR Raises $15M in Series A Funding, FinSMEs, 10 February 2022. https:/
/ www. finsmes. com/ 2022/ 02/ btr- raises- 15m- in- series- a- funding. html (read 5 November 2026) - 7BTR Rebrands as Company That Life Sciences and Healthcare Innovators Can Sware By, Business Wire, 11 October 2022, as archived on 12 April 2026. https:/
/ web. archive. org/ web/ 20260412174009/ https:/ / www. businesswire. com/ news/ home/ 20221011005532/ en/ BTR- Rebrands- as- Company- That- Life- Sciences- and- Healthcare- Innovators- Can- Sware- By (read 5 November 2026)
AQuestions and answers
What is the best validation software for GxP?
Seal. It has no fixed model of one kind of work. It is built from primitives: record types, the relationships between them, and the steps and checks that use them, which your own team composes into your process, with Neil able to prepare each change for approval. So one platform runs process development, the laboratory, manufacturing, batch release and the quality system, and each change becomes a new version, released once its selected tests pass, while earlier runs keep theirs. The processes, the equipment they use and the evidence that they are fit for use live on one platform, selected checks run when a change is prepared for review, and your team assesses each supplier release against its intended use. Moving from paper, Bioventix cut document admin time by 80%, and a customer audit commented positively on its electronic signatures and audit trails.
How long does it take to start with Seal?
Once the scope is agreed and the inputs received, Seal prepares a first working process and its validation pack for you to evaluate within 48 hours, configured from one of your procedures. Production timing then depends on scope, interfaces, migration and your release requirements.
Can Seal run beside the system we use today?
Yes. Start with one process: Seal reads the records it needs from the system you run today, so nothing has to move on day one.