FAQ
GMP compliance, answered.
Everything teams ask about Qualiva — troubleshooting and development, the readiness verdict, the standards we're built for, the AI, pricing, data, and validation. Can't find it? Ask us directly.
About Qualiva
What is Qualiva?
Qualiva is an AI-native GMP compliance platform for pharmaceutical manufacturers. It brings the entire quality system into one place, guides a factory from incomplete documentation to an inspection-ready quality management system, and produces a single, continuously verified readiness verdict — in both English and Arabic.
Who is Qualiva for?
Qualiva is built for pharmaceutical and sterile manufacturers and the teams responsible for GMP — Quality Assurance, the Qualified Person, QC, production, regulatory affairs, and plant management. It serves both established manufacturers tightening their compliance and newer facilities building a quality system for the first time.
What does "AI-native" mean here?
It means the intelligence is built into the platform, not bolted on. Qualiva guides you with smart defaults, explains requirements in plain language, drafts and reviews documents, investigates problems, and flags gaps as you work — so the system actively helps you reach compliance rather than just storing records.
How is Qualiva different from a traditional eQMS?
A traditional eQMS stores documents and records but leaves the thinking to you and your consultants. Qualiva is a system of guidance: it tells you where you stand against the standards, what's missing, how to close each gap, and helps you investigate and resolve real problems — with a readiness verdict that updates as you work.
What problem does Qualiva solve?
Compliance is usually fragmented across binders, spreadsheets, and disconnected systems, so quality teams rarely know their true inspection-readiness until an auditor finds the gaps. Qualiva consolidates the quality system into one platform and produces one defensible readiness verdict, so you always know exactly where you stand.
Can Qualiva help a factory that has almost no documentation yet?
Yes — Qualiva is designed to take a factory from zero. Guided onboarding assesses what you have, identifies what's missing, and walks you through building the rest with templates and AI assistance, so a facility without a formal QMS can reach a compliant one without hiring a consultant.
Solving real manufacturing problems
Can Qualiva help me troubleshoot a product or batch problem?
Yes — it's core to what Qualiva does. The Issue Troubleshooter diagnoses GMP problems — out-of-specification results, contamination, equipment faults, process issues — with AI-assisted root-cause analysis grounded in your own data, and recommends the corrective action, in minutes rather than weeks. The goal is to find the cause and recover the batch, not merely record that it failed.
Does Qualiva help with formulation and product development?
Yes. The Product Development Intelligence module gives AI-guided support for formulation, component compatibility, and the regulatory pathway, managed as a development project aligned with ICH Q8 and Q11 — so formulation and development work is guided and documented inside the platform, not handled on the side.
Can Qualiva help reduce production costs?
Yes — through quality. The largest avoidable costs in pharmaceutical manufacturing are failed and rejected batches, rework, deviations, and recalls. By catching issues early, investigating them properly, and preventing recurrence, Qualiva cuts those losses — and recovering even a single failed batch can outweigh the platform's cost.
Does Qualiva help investigate out-of-specification (OOS) and out-of-trend (OOT) results?
Yes. Qualiva runs structured OOS and OOT investigations from the QC laboratory and analytical methods, with AI-assisted troubleshooting, root-cause analysis, and linkage to any related deviation, batch, or method — so investigations are thorough, traceable, and closed properly.
Does Qualiva replace my compliance and troubleshooting consultants?
Qualiva is built to reduce your reliance on them. The guidance, investigation, and analysis you would normally bring a consultant in for are embedded in the platform and available continuously — and for deeper, specialised engagements, Qualiva's Expert Services can step in.
Documents, SOPs & records
How does document control work in Qualiva?
Qualiva manages controlled documents through their full lifecycle — draft, review, approve, version, and controlled change — with electronic signatures and an immutable audit trail, aligned to WHO GMP document-control expectations. SOPs, policies, and quality documents stay current, version-controlled, and inspection-ready.
Does Qualiva manage SOPs specifically?
Yes. SOP Intelligence authors, versions, approves, electronically signs, and tracks acknowledgement of every SOP, bilingual in English and Arabic, with the platform guiding you toward the SOPs a compliant quality system requires.
Can Qualiva generate GMP documents for me?
Yes. Qualiva generates GMP-ready SOPs, forms, and logbooks tailored to your factory — bilingual, with your branding, and exported as professional Word and lossless PDF documents on approval — so you build a compliant document set without starting from a blank page.
Where do reference and non-controlled documents live?
The Document Library is a searchable institutional repository for reference and non-controlled documents with expiry tracking, and the Master Document Index gives a single, cross-module searchable view of every document type on the platform.
Are Qualiva's electronic signatures compliant?
Yes. Qualiva uses PIN-based electronic signatures aligned with 21 CFR Part 11 and EU GMP Annex 11, manifested on the record with a full audit trail of who signed, what, and when. It is the controlled signing mechanism for all controlled documents.
Can I import my existing quality system into Qualiva?
Yes. The guided QMS import takes in your existing documents, organises them, and produces an AI gap report marking each area complete, partial, or missing — with a prioritised remediation roadmap — so you start from where you actually are.
Production & batch manufacturing
Does Qualiva support batch manufacturing records (BMR)?
Yes, end to end. You build structured master batch-record templates per product, and execute batches either as guided paper-on-glass — Qualiva generates the record and the operator completes it with an electronic signature — or as a fully electronic batch record (eBMR), with in-process controls, deviation capture, and digital sign-off.
Can Qualiva assess our existing paper or PDF batch records?
Yes. BMR Intelligence assesses existing paper or PDF batch records for gaps against GMP expectations, then lets you move to guided paper or full digital execution.
What is the Product Master?
The Product Master is a central, bilingual product catalogue — dosage forms, active ingredients, registration status, pack sizes — with AI ingredient intelligence that informs guidance, batch templates, and cross-contamination flagging across your portfolio.
Does Qualiva manage logbooks?
Yes. Equipment and area logbooks are maintained alongside batch execution — cleaning, environmental conditions, and usage — so the records that support a batch are captured and linked, not kept on loose paper.
Laboratory, materials & supplier quality
Does Qualiva include QC laboratory management?
Yes. The QC Laboratory module manages instruments, test requests and results, specifications, in-process controls, OOS/OOT investigations, and QC logbooks — the full quality-control workflow in one place.
Does Qualiva manage analytical methods?
Yes. The analytical methods library holds your methods with AI-assisted OOS/OOT troubleshooting and method case management, aligned to ICH Q2.
How does Qualiva handle raw materials and packaging?
Material Management tracks raw-material and packaging lots, incoming QC, disposition (released, quarantined, or rejected), and retest scheduling — so material status and traceability are always clear.
Does Qualiva manage supplier quality?
Yes. Supplier Quality covers supplier qualification, audits, certificates, and ongoing risk monitoring, so your approved-supplier status is current and defensible.
Does Qualiva support stability studies?
Yes. Stability Studies manages protocols, time-point scheduling, trend analysis, and out-of-trend triggers, aligned to ICH Q1 and Climatic Zone IVb requirements.
Quality events & change
How does Qualiva handle deviations and CAPA?
Qualiva runs the full deviation lifecycle — AI-assisted severity classification, investigation, corrective and preventive action, and effectiveness checks — with related records linked automatically, so nothing is investigated in isolation.
What is change control in Qualiva?
Change control lets you propose, assess, approve, implement, and verify changes to processes, documents, or equipment in a controlled, auditable way — with AI-assisted classification and risk assessment, approval gates, and effectiveness tracking — connected to the documents and records each change touches.
Does Qualiva manage complaints and recalls?
Yes. Complaints are triaged, investigated, and closed within the platform, and full recall management is supported with AI-drafted regulatory notices.
Does Qualiva support pharmacovigilance?
Yes. The pharmacovigilance module manages adverse-drug-reaction cases with AI causality assessment, ICSR narratives, and regulatory reporting.
Audit readiness, risk & oversight
What is the GMP readiness verdict, and how is it calculated?
The readiness verdict is a single, defensible measure of how inspection-ready your facility is, shown as a score and a band such as "Inspection-ready." It is computed by deterministic, traceable logic across the core GMP domains — weighting your document coverage and operational readiness, with open critical or major findings capping the band — and every figure traces back to a specific document or record, so it is auditable rather than a black box.
Can I trust that number in front of an inspector?
Yes — because it isn't an AI opinion. Qualiva computes compliance verdicts with verifiable, deterministic logic grounded in your own evidence, never by asking a model to assert a number, which makes the verdict defensible and reproducible.
Does Qualiva help with self-inspection?
Yes. The Self-Inspection programme plans internal GMP audit cycles with checklists, records findings, and tracks corrective actions to closure — so internal audits are continuous rather than an annual scramble.
Does Qualiva support risk management?
Yes. Risk Management provides ICH Q9 FMEA with RPN scoring and a 5×5 risk register with AI-assisted scoring.
Does Qualiva manage training and personnel?
Yes. Training Management maintains the training matrix (role against document), assignments, SOP-acknowledgement, and competency tracking; and the HR & Personnel module provides a WHO TRS 986 §11 personnel system — org chart, staff register, job descriptions, training records, medical fitness, authorised signatories, and gowning.
Does Qualiva cover engineering and maintenance?
Yes. Engineering & Maintenance manages the equipment register, calibration, preventive maintenance, IQ/OQ/PQ qualification, and facility and room GMP assessment.
Validation & qualification
Does Qualiva support validation and qualification?
Yes. The Validation & Qualification Suite unifies IQ/OQ/PQ, process validation, computerised-system validation, and cleaning-validation protocols and reports in one place.
Does Qualiva handle cleaning validation?
Yes. Cleaning Validation covers the full non-sterile programme — cleaning validation master plan, MACO calculations, protocols, execution, reports, and revalidation.
Sterile manufacturing (Annex 1)
Does Qualiva support sterile and aseptic manufacturing?
Yes, on the Sterile Manufacturing plan. The sterile suite provides the full EU GMP Annex 1 compliance layer — environmental monitoring, media fills / aseptic process simulation, container-closure integrity, sterilisation, the contamination control strategy, and water-system monitoring.
Is sterile cleaning validation included?
Yes, on the Sterile Manufacturing plan — covering disinfectant and depyrogenation validation, aseptic MACO, and environmental-monitoring correlation.
Standards & inspections
Which GMP standards does Qualiva support?
Qualiva is built around WHO GMP, EU GMP, EU GMP Annex 1 (sterile), Annex 11 (computerised systems), ICH Q1/Q2/Q8/Q9/Q10/Q11, Arab GMP, and Climatic Zone IVb stability requirements.
Does Qualiva help with regulatory inspections?
Yes. Qualiva keeps documentation, records, and processes inspection-ready year-round, maintains a multi-authority inspections register, and gives you a live readiness verdict — so you walk into an inspection knowing where you stand.
What is Annex 11 and how does Qualiva address it?
Annex 11 is the EU GMP requirement for computerised systems in GMP environments. Qualiva is built to align with it — audit trails, access control, and electronic signatures — so the platform supports your Annex 11 obligations rather than creating new ones.
Ask Qualiva & the AI
What is Ask Qualiva?
Ask Qualiva is the platform's always-on GMP assistant, available on every page. It answers regulatory and platform questions, knows your factory's records, drafts and reviews documents, and can create records on your confirmation — bilingual, with memory across conversations.
Does the AI make compliance decisions for me?
No — and this is deliberate. Compliance facts and verdicts are always computed by deterministic, verifiable logic, never asserted by an AI model. The AI guides, explains, drafts, and interprets; the verdict is calculated from your evidence. That separation is what makes the verdict defensible in an inspection.
Can the AI invent or get compliance facts wrong?
Qualiva is designed to prevent that. The readiness verdict and compliance status are computed deterministically, not generated by the AI, so the numbers you rely on can't be hallucinated; the AI's role is grounded in regulatory knowledge and your factory's own data.
What AI powers Qualiva?
Qualiva is powered by Anthropic's Claude, applied within a compliance-safe architecture where the AI guides and interprets but never asserts the compliance verdict.
Onboarding & getting started
How do I get started with Qualiva?
You request access, and Qualiva guides you through setting up your factory from day one. There is no self-service sign-up because each facility is configured to its products, standards, and quality maturity during a guided onboarding.
What happens during onboarding?
Onboarding establishes your factory's identity and quality maturity, imports your existing documents, and produces a gap report so you can see exactly what's in place and what's missing — then guides you through closing the gaps as your modules unlock. It works for both blank-slate and existing-QMS factories.
Do I need a consultant to use Qualiva?
No. Qualiva provides the guidance, templates, and gap analysis a consultant would, so a factory can build a compliant quality system in-house — with Expert Services available for deeper engagements.
How quickly do I see value?
You see your gap report and the shape of your readiness early in onboarding, once your existing documents are imported and assessed; the platform then shows progress continuously rather than making you wait for a final audit.
Pricing & plans
How much does Qualiva cost?
Qualiva has three monthly plans: Pro Intelligence at $10,000/month, EU GMP Pathway at $15,000/month, and Sterile Manufacturing at $22,000/month. Annual plans are billed at ten months' price for twelve months of service.
What's included in each plan?
Pro Intelligence covers the core quality system, documents, deviations and CAPA, audit readiness, and Ask Qualiva. EU GMP Pathway adds the full EU GMP and Annex 11 readiness pathway. Sterile Manufacturing adds the Annex 1 sterile suite and its validation, for aseptic and sterile production.
Is there a free trial or free tier?
No. Qualiva is a production compliance system that holds real regulated data and guides real inspection-readiness, so it's offered as a committed plan rather than a free trial. Access begins with a request and a guided setup of your facility.
How does annual billing work?
Annual plans are charged at ten months' price for twelve months of service — effectively two months free for committing annually.
Which plan do I need?
Start with Pro Intelligence for a complete AI-guided quality system; choose EU GMP Pathway for the EU GMP and Annex 11 pathway; choose Sterile Manufacturing for Annex 1 aseptic production, which includes everything in the lower tiers.
Data, security & ownership
How is my factory's data protected?
Each customer's data is isolated at the database level, so one factory's records are never accessible from another's. Access is controlled by role, and sensitive actions are electronically signed and audit-trailed.
Where is my data hosted?
Qualiva is hosted on secure, EU-based infrastructure in Germany, with encrypted file storage — supporting customers with EU data-residency expectations.
Can Qualiva staff see my data?
No. Customer factory data is walled off from Qualiva's administrators by design, separated at the access and database level, so operating the platform does not grant access to your records.
Is my data used to train AI models?
No. Your factory's data is not used to train AI models; the AI processes your data to assist you in the moment, and it is not harvested for training.
Do I own my data, and can I get it out?
Yes. Your data is yours and fully portable — Qualiva provides complete data export across all record categories, available scheduled or on demand, so you are never locked in.
Does Qualiva meet 21 CFR Part 11 and Annex 11?
Qualiva is built to align with 21 CFR Part 11 and EU GMP Annex 11 — electronic signatures, audit trails, access control, and record integrity — so the platform supports these requirements rather than putting them at risk.
Languages & regions
Is Qualiva available in Arabic?
Yes. Qualiva is fully bilingual in English and Arabic, with complete right-to-left (RTL) support across the platform — built so Arabic-speaking quality teams work in their own language, not a translated afterthought.
Which regions does Qualiva serve?
Qualiva serves pharmaceutical manufacturers across the Arab and MENA region and globally, with standards coverage built for manufacturers operating to international expectations.
Validation of Qualiva itself
Is Qualiva itself a validated system?
Yes. Qualiva is built and maintained following GAMP 5 and computerised-system-validation (CSV) principles, and provides a validation package to support your qualification of the platform as a computerised system under EU GMP Annex 11.
Does Qualiva provide validation documentation?
Yes. Qualiva supplies the validation documentation your quality team needs to qualify the platform within your computerised systems inventory under Annex 11 — provided as part of onboarding.
Expert Services & support
What are Qualiva's Expert Services?
Expert Services let you request specialist GMP help directly inside the platform — for deeper engagements beyond what the software guides you through — with the request auto-filled with your factory context and a full communication history kept in one place.
How do I get support?
Support is built into the platform: a request form auto-fills your factory and account context so you don't re-type it, and your full support history stays with your account.
Still have a question?
Ask Qualiva on this page, or request access and we'll set up your factory — guided from day one.
Request access