Biotech QMS software, ready before your first GMP batch
Put SOPs, training, deviations, CAPAs and change control under control before your first inspection or CDMO audit, in one eQMS your team can sign up for and start using on its own.
What your QMS must cover, and where it lives in QFacts
Each requirement links to the module that handles it. The references name the chapter or clause an inspector will check.
Controlled SOPs from day one
Write, review and approve SOPs, specifications and protocols with version control and electronic signatures. Each approved revision gets an effective date and can require training in the same step.
EU GMP Chapter 421 CFR 211.100See how it worksTraining records that grow with the team
Assign training by curriculum as you hire, test understanding with quizzes and keep a signed record of every attempt for your first inspection.
EU GMP Chapter 221 CFR 211.25See how it worksDeviations with batch impact
Log deviations with the impacted batches per product, let QA assess the impact and move events with impact into an investigation.
EU GMP Chapter 121 CFR 211.192See how it worksCAPAs with an effectiveness check
Link corrective and preventive actions to the root cause, assign owners and due dates, and close them only after their effectiveness has been verified.
ICH Q10 3.2.2See how it worksChange control as processes mature
Record the current state, the proposed state and the justification for every change, assess the impact and add board approval when the impact calls for it.
ICH Q10 3.2.3See how it worksElectronic records and signatures
Unique user accounts, role-based access, electronic signatures that state their meaning, and an audit trail that cannot be edited or deleted.
21 CFR Part 11EU GMP Annex 11See how it works
One price per user, every module included
Full Access users cost €57.50 per month and Lite users €17.25, billed monthly without a long-term contract. Annual billing lowers the rate. All seven modules are included and there is no implementation fee.
Example: 5 Full Access and 10 Lite users cost €460 per month on monthly billing.
Start with a 14-day free trial. No credit card required.
Regulations and standards in scope
Frequently asked questions
When should a biotech start with an eQMS?
As soon as procedures and training records have to be controlled: typically before your first GMP manufacturing, clinical batch or CDMO audit. Starting early costs less than migrating paper records later, and with per-user pricing you only pay for the people who use it.
Does QFacts meet 21 CFR Part 11 and EU Annex 11?
QFacts provides the technical controls both expect: unique user accounts, role-based access, electronic signatures that state their meaning, and an audit trail that cannot be edited or deleted. Compliance also depends on how you validate and use the system, so we supply validation-ready document templates to support it.
How much does QFacts cost for a biotech team?
Full Access users cost €57.50 per month. Lite users, who read documents and complete their training, cost €17.25. Annual billing lowers the rate. All seven modules are included and there is no implementation fee.
Can we try QFacts before we buy?
Yes. Sign up for a 14-day free trial with access to all features. No credit card is required, and you can book a walkthrough with our team at any time.
Put QFacts to work for 14 days.
Sign up directly and explore how QFacts connects your documents, training and quality workflows. Start with a process your team knows.