Swat iQua SuiteNorth America
Pharma quality software for the US and Canada.
Designed for 21 CFR Part 11 and FDA cGMP, and for Health Canada’s GMP expectations — with every demo and call booked at a time that suits your time zone.
- Designed for 21 CFR Part 11
- FDA cGMP controls on one audit trail
- Demos in your time zone
- Pay only for live modules
Your regulators
Designed for the rules you are inspected against.
-
21 CFR Part 11
Electronic records and signatures: audit trails, signature manifestations, access and authority checks.
21 CFR Part 11 -
FDA cGMP
21 CFR 210/211 — production and process controls, laboratory controls, records and reports.
FDA cGMP -
Health Canada & PIC/S
Canada’s GMP expectations align closely with PIC/S, which Health Canada is a member of.
PIC/S GMP
Try it first
See it before you schedule a call.
-
Product tours
Four 2-minute tours on real screens — no sign-up.
Take a tour -
Part 11 self-assessment
26 questions with clause references and a gap report.
Start the assessment -
ROI in US dollars
Estimate the hours paper and spreadsheets cost you.
Open the calculator
Delivered remotely
How we take you live from India.
Our team in Rajkot implements Swat iQua Suite remotely, in your working hours where they overlap with ours — the same way we have supported UK laboratories since 2016.
- 01
Online workshops
We map your processes, roles and records with your team over video calls.
- 02
Configuration
Sites, users, workflows, masters and signatures set up for your organisation.
- 03
Data migration
Legacy records mapped, trial-loaded, reviewed by you and reconciled.
- 04
Validation & training
Requirements traceability, Part 11 controls evidence and role-based training.
- 05
Go-live & support
Typical go-live in 1–3 months, then direct support from the team that builds the product.
Talk to us
Our hours, in your time zone.
One team, based in Rajkot, India. Where our hours do not overlap with yours, book a call at a time that suits you.
- India
- 09:30 – 19:00 ISTMon–Sat · Our office hours
- United Kingdom
- 09:00 – 13:30 GMTMon–Fri · Live calls, your local time
- US & Canada
- By appointment your time zoneAny weekday · Pick a time on the demo form — outside our hours is fine
Book a demo at a time that suits you WhatsApp us (opens in a new tab)
FAQ
Frequently asked questions
Can’t find your answer? Talk to our team — we reply within one business day.
How do we talk to you from the US or Canada?
Book a demo or call on the form and pick a date and time in your time zone — outside our office hours is fine. Email and WhatsApp work any time.
Is Swat iQua Suite Part 11 compliant?
It is designed to comply with 21 CFR Part 11, with the technical controls the rule requires. Validation, procedures and the FDA certification letter remain the regulated company’s responsibility.
Do you have customers in North America?
Yes — Swat iQua Suite serves labs and manufacturers in India, the UK, the US, Canada and Africa.
Ready to see Swat iQua Suite in action?
Book a free, personalised demo and see how Swat iQua Suite takes your plants, labs and quality teams from paper to inspection-ready.