Pharma QMS software for GMP teams
Run SOPs, GMP training, deviations, complaints, CAPAs and change control in one eQMS, with electronic signatures and an audit trail an inspector can follow from start to finish.
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 and GMP documents
Draft, review and approve SOPs, work instructions and specifications with version control and electronic signatures. QA sets the effective date and can require training in the same approval.
EU GMP Chapter 421 CFR 211.100See how it worksGMP training that follows your documents
Training reaches operators through curricula by department or job function. Quizzes check understanding, every attempt is signed, and training records are ready for inspection.
EU GMP Chapter 221 CFR 211.25See how it worksDeviations and complaints with batch impact
Log a deviation with the impacted batches per product and send it to QA for an impact assessment. Complaints get a recurrence check and an impact level, and events with impact move into an investigation.
EU GMP Chapter 821 CFR 211.19221 CFR 211.198See how it worksCAPAs with an effectiveness check
Turn investigation findings into corrective and preventive actions with owners and due dates, and close a CAPA only after its effectiveness has been verified.
ICH Q10 3.2.2EU GMP Chapter 1See how it worksChange control with impact assessment
Each change records the current state, the proposed state and the justification. QA assesses the impact, and a change control board approval is added when the impact calls for it.
ICH Q10 3.2.3EU GMP Annex 15See 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.
Start with a 14-day free trial. No credit card required.
Regulations and standards in scope
What QFacts does not replace
Better to know this before your trial than after it.
- Batch records and manufacturing execution. QFacts links deviations to impacted batches, but it does not execute or review batch records.
- Laboratory systems. Out-of-specification results start in your LIMS; the deviation, investigation and CAPA that follow can live in QFacts.
- Your own validation. QFacts follows GAMP 5 for its platform and provides validation-ready document templates, but validating it for your intended use remains your responsibility.
Frequently asked questions
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 pharma 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.
Can we bring our existing SOPs?
Yes. Upload your current documents into the controlled system and route them through review and approval, so each one gets a version history and an effective date in QFacts.
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.