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Kryshara

FAQ

Frequently asked questions

Straight answers to what buyers, IT teams and quality leads ask us first.

Products

Do we have to buy both products?

No. Helix and Pharos each run on their own. Together they share one workforce: a person is created once in Helix, and Pharos receives them as a governed, effective-dated resource.

Who are Helix and Pharos built for?

Generics manufacturers, API makers, CDMOs and CROs. Helix is for HR, plant HR, payroll, quality and EHS teams. Pharos is for programme directors, project managers, finance, regulatory and quality teams. We do not build clinical trial management, electronic data capture or eCTD publishing.

Is there a mobile app?

Helix includes a self-service mobile app for Android and iOS that covers punch, attendance, learning, documents and tasks, with biometric unlock. The employee portal also works in a phone browser.

Can we configure the products ourselves?

Yes. Fields, forms, workflows, policies, reports, stage templates, approval routes, reason codes and terminology are tenant configuration. They are versioned, effective-dated and audited, and they do not need a vendor ticket.

How is pricing structured?

Pricing depends on the modules you switch on, the number of sites and users, and the deployment model. Contact us with a rough picture of your organisation and we will give you a clear proposal.

Deployment and security

Where does the software run?

On your infrastructure. Both products are built for on-premise deployment in your data centre, or in a cloud account that you own and control. There is no dependency on a managed cloud service, and no customer data leaves your network for a third-party service.

Which databases are supported?

PostgreSQL today. The schema and query style are deliberately kept portable to Oracle and Microsoft SQL Server.

How is tenant data isolated?

The tenant is resolved on the server, from the URL in Helix and from the verified token in Pharos. It is never trusted from the browser, and every query is tenant-scoped.

Does it integrate with our existing systems?

Yes. Helix connects to biometric devices, access control, Active Directory, OpenID Connect and SAML identity providers, banks, statutory portals and GxP systems such as your LMS, QMS and DMS. Pharos states its boundary with your eCTD publisher, LIMS, MES, QMS and ERP, and integrates rather than replaces them.

How do we migrate our existing data?

Through governed imports with preview, validation and commit. In Pharos a bulk import raises change requests through the same approval route as a manual change, so migration leaves an audit trail too.

Compliance

Are the products validated?

Validation is something a regulated company does to a system in its own environment, so no vendor can hand you a validated system. What we provide is software designed to the relevant controls, together with requirements, a traceability matrix, test evidence and IQ and OQ artefacts that your quality and CSV teams can use to qualify it.

Which regulations are the products designed around?

21 CFR Part 11 and EU GMP Annex 11 for electronic records and signatures, ALCOA+ data integrity principles, Schedule M and WHO-GMP training expectations, India's DPDP Act, 2023 for personal data, and Indian labour and factory law for the statutory modules.

What makes the audit trail tamper-evident?

It is append-only and hash-chained per tenant: each entry includes the hash of the entry before it. Verification detects any edit, deletion or reordering. In Pharos the business change, the audit event and the record snapshot commit in one database transaction, or none of them do.

How do electronic signatures work?

The signer re-authenticates and is shown exactly what they are signing and what the signature means. The signature is bound to a hash of the record's content, so it cannot be carried over to an edited version. Bulk signing is deliberately not offered.

Working with us

What does a typical engagement look like?

A working session on your sites, SOPs, programmes and rules. Then a pilot on one site or one portfolio, with real data, on your infrastructure, against agreed acceptance evidence. Then a rollout site by site, with a validation plan shaped with your quality team.

How long does a pilot take?

Typically weeks rather than months, depending on scope and how quickly environments and master data are available.

How do we get support?

Customers reach us through the support channel agreed in their contract. For anything else, write to the address on our contact page.

Did not find your question?

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