European Alternatives to MasterControl
Looking for a European alternative to MasterControl? MasterControl Solutions, Inc. is based in Salt Lake City, Utah, and publishes no price list: its pricing page speaks of flexible plans without figures, so budgets are set in sales conversations and the platform bundles quality with manufacturing and asset management.
The European tools below range from a free tier for medical device startups to validated eQMS packages and plant quality suites, all contracted from the EU, UK or Israel.
How we rank these tools — 4-step process
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1
European ownership, verified
The company is headquartered and incorporated in the EU, EEA, the UK, Switzerland or Israel, and processes customer data in Europe or Israel. A US parent company disqualifies a tool from this page regardless of where its servers are.
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2
Category fit and hands-on review
What the tool actually does, who it suits, and where it falls short — checked against the vendor’s own documentation, changelog and pricing page rather than its marketing copy.
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Compliance and pricing check
GDPR posture, hosting location and the prices quoted on this page are verified against the vendor’s public pricing before publication, and re-checked when we revisit the category.
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Position on this page
Placement on this page can be paid, and that can affect which tools appear here and the order they appear in. It never buys a good review: a tool that fails the checks above is not here at any price, and payment does not change the shortcomings we write about. A vendor can ask us to correct a factual error — not to remove a criticism.
Vendors can pay for visibility on this page. It never changes what an entry says about a product, including the criticism, and we earn nothing when you click through to a vendor. Vendors can pay for more visibility, higher up on the review pages; it never affects which tools are listed. Editorial policy
11 European Alternatives to MasterControl
Qualio
Cloud eQMS for medtech and biotech with AI gap analysis
SimplerQMS
Pre-validated eQMS from Copenhagen with a listed starter price
Scilife
Brussels eQMS for pharma and medical devices with module tiers
OpenRegulatory (Formwork)
Low-cost eQMS and technical documentation for medical device startups
Cognidox
Cambridge eQMS built on document control for device developers
Babtec
Wuppertal quality assurance and management system software
CAQ AG
Modular CAQ.Net software for plant quality and audits
Ideagen
Nottingham quality platform with CAPA, audits and document control
Orcanos
Israeli eQMS joined to requirements and test management
isoTracker
Surrey subscription QMS for ISO 9001 and ISO 13485 modules
ConSense
Aachen process and management system software, German-first
Key takeaways
- MasterControl Solutions, Inc. is based in Salt Lake City, Utah, and its pricing page names no figures.
- OpenRegulatory (Formwork) is the only tool among the eleven that lists a free tier, with 5 user seats.
- SimplerQMS and Cognidox publish entry prices, USD 17,500 a year and 6,000 pounds a year respectively.
- Babtec and CAQ AG are the German options for plant quality with FMEA, SPC and IATF 16949 coverage.
- Of the eleven tools, only CAQ AG describes an on-premises option next to SaaS.
Why people leave MasterControl
MasterControl Solutions, Inc. sells quality software from Salt Lake City, Utah. The product is an electronic quality management system: the place where a company keeps its controlled documents, corrective and preventive actions, audit findings and training records, and where an inspector looks when asking how a batch or a device was released. It also reaches beyond the quality office, because the platform bundles quality with manufacturing and asset management.
That breadth is the first reason buyers compare it with other tools.
A company that only needs document control and CAPA for a first ISO 13485 audit pays attention to a platform designed to carry a whole plant, and the second reason follows from how that is sold: the pricing page talks about flexible plans and prints no figure at all. A budget is therefore set in a sales conversation, after a demo, and cannot be tested against alternatives in advance.
The third reason is jurisdiction. MasterControl is a US company, so a European customer signs with a US supplier and has to check, in the order form, where records are hosted and which law governs the contract. The European tools below are contracted from Ireland, Denmark, Belgium, Germany, the United Kingdom or Israel, and each states its own position on hosting.
- No price to compare before the first call The MasterControl pricing page describes flexible plans and shows no amount. Against that, OpenRegulatory prints Free, 99 euro and 499 euro monthly tiers, SimplerQMS shows a Starter plan from USD 17,500 a year, and Cognidox states annual plans from 6,000 pounds. A buyer who wants a rough line in the budget sheet before booking a demo gets one from three of the eleven tools listed here.
- A platform sized for plants, bought by teams that are not plants Quality, manufacturing and asset management sit in one MasterControl offering. A software-as-medical-device company or a biotech with no production line may never open the manufacturing side. Qualio and OpenRegulatory (Formwork) stay on documents, CAPA and design records, and Orcanos ties quality records to requirements and tests, so the scope matches what such a team audits.
- The contracting party sits outside Europe A purchase from Salt Lake City means a US supplier in the vendor file. SimplerQMS A/S is registered in Copenhagen, Scilife N.V. has its EMEA office in Brussels, OpenReg GmbH is entered in the Mannheim commercial register, and Everworks Limited (Qualio) has its registered office in Dublin. A supplier-risk questionnaire has an easier time with those entries.
- Plant quality is a different job from a quality file A factory that runs control plans, FMEA and statistical process control needs inspection tooling that a document-first system treats as an add-on. Babtec and CAQ AG, both in Germany, were built around that work, with IATF 16949 and AIAG and VDA rules named by the vendors. For such a plant the alternative is a different kind of product, not a cheaper copy.
What you have to replace, not just match
Moving off MasterControl means replacing records, not only software. The controlled documents with their revision history, the open CAPAs and deviations, the training matrix and the audit schedule all have to arrive in the new system in a state an inspector accepts. Some vendors help with this: Cognidox includes a free migration of 500 documents from its Growth tier, and SimplerQMS bundles implementation, onboarding and validation in the yearly fee.
If the MasterControl installation also covers manufacturing or asset management, those modules have no equal in the life-science tools. Qualio, SimplerQMS and Scilife do not describe manufacturing execution in the pages checked. CAQ AG covers inspection, gauge management and audits for a plant, and Ideagen sells quality next to EHS and compliance, so the production side is usually split across two products after the move.
Validation is the third item. Pharma and device teams treat the quality system as a computerised system that has to be validated before use. SimplerQMS states delivery validated according to ISPE GAMP 5, CAQ AG says validation capability is part of every solution, and Ideagen lists software validation as a related solution. Others leave the validation plan to the customer, which should be priced into the comparison.
The alternatives compared
| Position | Tool | Headquarters | Pricing | Jurisdiction |
|---|---|---|---|---|
| #1 | Qualio | Dublin, Ireland | Three plans (Foundation, Growth, Scale) without a price list; every plan carries an implementation fee | EU (Ireland) |
| #2 | SimplerQMS | Copenhagen, Denmark | Starter tier from USD 17,500 a year for up to 15 users; Team and Enterprise tiers are quoted | EU (Denmark) |
| #3 | Scilife | Brussels, Belgium | Free trial; tiers Essential, Core and Core+ are priced on request | EU (Belgium) |
| #4 | OpenRegulatory (Formwork) | Weinheim, Germany | Free edition; Starter at 99 euros a month; QMS + Techdoc at 499 euros a month, plus VAT | EU (Germany) |
| #5 | Cognidox | Cambridge, United Kingdom | Yearly subscription by user tier, starting at 6,000 pounds | United Kingdom (adequacy decision, outside the EEA) |
| #6 | Babtec | Wuppertal, Germany | Quoted on request | EU (Germany) |
| #7 | CAQ AG | Rheinboellen, Germany | Quoted on request; a maintenance contract covers updates and support | EU (Germany) |
| #8 | Ideagen | Nottingham, United Kingdom | Pricing on request | United Kingdom (adequacy decision, outside the EEA) |
| #9 | Orcanos | Ramat Gan, Israel | Quoted on request | Israel (outside the EU/EEA) |
| #10 | isoTracker | Oxted, United Kingdom | Subscription per module; the checkout page names GBP, USD and EUR but showed no amounts to the crawler | United Kingdom (adequacy decision, outside the EEA) |
| #11 | ConSense | Aachen, Germany | Quoted on request | EU (Germany) |
How each alternative compares to MasterControl
Best for: Medtech and biotech teams that need a first audited QMS with design controls and framework mapping.
Against MasterControl, Qualio gives up the manufacturing side and keeps the product-development side. Everworks Limited, trading as Qualio, contracts from Dublin. Plans are Foundation, Growth and Scale, with 5 editing users on Foundation and 10 on Growth, and unlimited basic users who only read and sign.
The compliance frameworks are mapped to existing documents, with a gap analysis and a Copilot that drafts and reviews text. Continuous regulatory monitoring and automated evidence collection are listed on Growth only. Pricing stays on request and an implementation fee applies on every plan, so the price is as hidden as at MasterControl.
What Qualio does better than MasterControl
- Contracting entity registered in Ireland instead of Utah
- Design controls linked to Jira, GitHub, GitLab, Azure DevOps and TestRail
- Unlimited read and sign users on every plan
- Scope limited to quality, which shortens a first rollout
Where Qualio is a step down from MasterControl
- No manufacturing execution in the pages checked
- Data location not stated and no price list
- Extra frameworks beyond the included three or five cost more
Standout against MasterControl. It is the only tool here that lists a Copilot drafting inside the quality workflows next to framework gap analysis.
Best for: Pharma, biotech, device and lab teams that want validation and onboarding inside one subscription.
SimplerQMS A/S is entered in the Danish company register under CVR DK39039923, and the vendor itself holds an ISO 13485:2016 certificate. Where a MasterControl purchase is a platform plus a project, the pricing page here lists implementation, onboarding, validation, user training and cloud hosting inside the subscription, and states delivery validated to ISPE GAMP 5.
The Starter plan is shown from USD 17,500 a year for up to 15 users, a figure MasterControl does not print. Hosting runs on Amazon Web Services and Microsoft Azure, which are US-parented providers, so the Danish contract does not remove US infrastructure. Auditors can log in free with a read-only Viewer licence.
What SimplerQMS does better than MasterControl
- A visible starting price in place of a sales-led quote
- Validation, onboarding and hosting bundled in the fee
- Free read-only licences for inspectors and auditors
- Danish A/S with a CVR number and a named supervisory authority
Where SimplerQMS is a step down from MasterControl
- Price shown in US dollars, not euros
- Hosting on US-parented cloud providers
- Aimed at life sciences, with little plant-floor tooling
Standout against MasterControl. It is the only tool here whose vendor holds an ISO 13485:2016 certificate itself.
Best for: GMP and GDP teams that prefer to roll out in stages and want a European data centre in the contract.
Scilife N.V. lists its EMEA office at Kantersteen 47 in Brussels. Compared with an all-at-once platform such as MasterControl, the Essential tier covers document management, training, competences, records and KPIs, Core adds CAPAs, change control and quality events, and Core+ is the all-in-one tier. A team can therefore start small and switch modules on.
The pricing FAQ says GDPR customers are placed in a European data centre, while the security page says the platform runs on Amazon AWS. A Scilife Inc office also exists in New York, and the terms page does not name the contracting company, so the order form decides which entity you sign with. Prices are on request.
What Scilife does better than MasterControl
- Staged tiers instead of one large project
- A European data centre named in the pricing FAQ
- Controlled printing and reconciliation of paper copies
- A free trial before the first demo conversation
Where Scilife is a step down from MasterControl
- Runs on a US-parented cloud and has a US sister office
- No published prices on any tier
- Terms page leaves the contracting company unnamed
Standout against MasterControl. It is the only tool here with a separate product for controlled printing of paper copies.
OpenRegulatory (Formwork)
The low-cost route for medical device startups, with prices on the page
Best for: Seed and Series A device companies that need a QMS and a technical file without a quality department.
OpenReg GmbH in Weinheim is entered at the Amtsgericht Mannheim under HRB 757780. Formwork sells a free Community Edition with 5 seats, Starter at 99 euros a month and QMS + Techdoc at 499 euros a month with unlimited seats, all plus VAT. Beside a MasterControl quote, that is a different order of magnitude, and it is readable without a call.
The scope is narrow on purpose. Requirements, risks and tests are traced in one tree, with ISO 13485, IEC 62304, ISO 14971 and IEC 62366 templates preloaded and an AI step that drafts SOPs for review. Data sits in France and Germany and there is no self-hosted edition. A pharma plant or a multi-site company will outgrow it.
What OpenRegulatory (Formwork) does better than MasterControl
- Free tier and two published monthly prices
- Data in France and Germany without Amazon, Google or Microsoft
- QMS and technical documentation in one tool
- Templates for the main device standards preloaded
Where OpenRegulatory (Formwork) is a step down from MasterControl
- Medical devices only, with no batch or GMP deviation handling
- Document management is limited on the free tier
- Not built for multi-site enterprises
Standout against MasterControl. It is the only tool here that publishes a price of zero and says it avoids all three US hyperscalers.
Best for: Hardware and device developers whose product history lives in documents and phase gates.
Cognidox Limited is registered in England under company number 06506232 and works from Cambridge. Its package is a document store extended with design controls, CAPA, supplier management and training, which the vendor calls a Lean eQMS. Tiers allow 5, 30, 50 and 100 users, and annual subscriptions start from 6,000 pounds, a number MasterControl does not print.
Growth adds e-signatures and a free migration of 500 documents, which matters if you arrive with a document backlog. The privacy policy states that Cognidox is wholly owned by Recur Software Technologies Inc., so the parent is outside Europe even though the contract is British. No manufacturing execution is described and no data location is stated.
What Cognidox does better than MasterControl
- Published entry price in pounds
- Phase-gate design controls for product development
- Free migration of 500 documents from the Growth tier
- Calibration and metrology labs named as a target group
Where Cognidox is a step down from MasterControl
- User caps push a growing team up the tier ladder
- Parent company outside Europe
- No data location stated and no manufacturing execution
Standout against MasterControl. It is the only tool here that starts from document management and adds the quality modules around it.
Best for: Automotive, electronics and machinery suppliers that run FMEA, control plans and SPC.
Babtec Informationssysteme GmbH is registered at the Amtsgericht Wuppertal under HRB 10259. The range is split into quality assurance (control plans, FMEA, in-production inspection, SPC) and management systems (requirements, documents, processes). That is the part of a MasterControl installation a supplier often cannot do without, delivered by a vendor that states about 1,300 customers.
Standards named by the vendor include DIN EN ISO 9001, IATF 16949 and the AIAG and VDA guidelines. An ISO/IEC 27001 certification is announced, and an AI assistant called Quorix is described as in preparation, so it should not count in an evaluation. Price, hosting model and founding year were not stated on the pages checked.
What Babtec does better than MasterControl
- FMEA, control plans and SPC as core products
- IATF 16949 and AIAG and VDA rules named by the vendor
- German GmbH with a Handelsregister entry
- Third-party interfaces for existing plant systems
Where Babtec is a step down from MasterControl
- Little GxP validation content for pharma teams
- No price and no stated hosting model
- The AI assistant is announced, not shipped
Standout against MasterControl. It is the only tool here that sells FMEA and control plans as separate products next to its document tools.
Best for: Plant quality departments that want inspection, gauges and audits on one data model.
CAQ AG Factory Systems, with its address in Rheinboellen, states that CAQ.Net has been in use since 1993. It starts on the shop floor with inspection, initial sample inspection and gauge management and extends upward into process, document, training and change control, audits, suppliers and complaints. MasterControl approaches a plant from the document side; this comes from the other direction.
Core tools include APQP, control plans, FMEA, MSA, SPC and PPAP, with interfaces to SAP, ARBURG, ALS and CAD systems. The software is described as fully configurable with a no-code designer, floating licences and a choice of SaaS or on-premises. Prices are on request, with a maintenance contract for updates and support, and configuration effort is probably high.
What CAQ AG does better than MasterControl
- On-premises deployment next to SaaS
- Inspection and gauge management inside the same suite
- SAP and CAD interfaces named on the site
- Floating licences and a no-code designer
Where CAQ AG is a step down from MasterControl
- No startup tier or published price
- Longer configuration project than a template-based tool
- No pharma validation pack described
Standout against MasterControl. It is the only tool here that lets the customer pick between SaaS and on-premises hosting.
Ideagen
A UK group that bundles quality with EHS and compliance, like MasterControl bundles plant modules
Best for: Larger organisations that want quality, audit and EHS processes from one supplier.
Ideagen plc is registered in England and Wales under number 02805019, with its registered office in Ruddington, Nottingham. Its quality product joins document control, CAPA, audits, training, supplier quality and inspection, and change management tracks changes in standards and regulations into workflows. In breadth it is the closest of the eleven to what MasterControl sells.
Named standards include ISO 9001, ISO 13485, 21 CFR Part 11, AS9100 and IATF 16949, which are vendor statements. Customer stories name Nuffield Health, South Tees NHS and Torbay Pharmaceuticals. No price is public, hosting is not stated, and a small team may pay for modules it never opens, so the size advantage can turn into a cost.
What Ideagen does better than MasterControl
- Quality, EHS and compliance records under one supplier
- Regulatory change tracking linked into workflows
- UK plc entry with a registered office and company number
- Healthcare and pharma references named on the site
Where Ideagen is a step down from MasterControl
- No public price and no stated hosting location
- Portfolio larger than a small team needs
- Sits outside the EEA, under a UK adequacy decision
Standout against MasterControl. It is the only tool here that links regulatory intelligence about standard changes to quality workflows.
Best for: Device companies whose software developers and quality staff work in separate tools today.
Orcanos Ltd. is named in its privacy policy as database owner under Israeli law, with an office on Ariel Sharon Street in Ramat Gan. The platform has three modules: regulated ALM for requirements, risk, tests and defects, an eQMS, and an AI assistant called Ask Paul. Against MasterControl, the difference is the engineering side, where a design change triggers a quality impact assessment without a second tool.
The eQMS covers document control with 21 CFR Part 11 signatures, CAPA, complaints, audits, suppliers and training. The vendor quotes go-live in 14 days and 24 days on average, both vendor claims. Jira, GitHub and Azure DevOps are integrated. The terms page is dated May 2019, which suggests legal pages are not refreshed often. Prices and hosting location are unpublished.
What Orcanos does better than MasterControl
- Requirements, tests and quality records on one data layer
- ISO 14971 risk coverage next to design controls
- Developer-tool integrations with Jira, GitHub and Azure DevOps
- A stated go-live period with templates
Where Orcanos is a step down from MasterControl
- Medical device focus only
- No published prices or hosting location
- Legal pages look dated
Standout against MasterControl. It is the only tool here that includes a regulated application lifecycle module in the same platform.
Best for: Small and mid-sized firms certifying to ISO 9001 or ISO 13485 that want to add modules over time.
isoTracker Solutions Ltd is registered in England and Wales under number 4621066 and has its address in Oxted, Surrey. Against a MasterControl contract, the buying model is the reverse: customers subscribe and pay only for the modules they need, with licences either named or concurrent. A 60-day trial of the full version runs without a credit card, and entered data can be kept after subscribing.
Landing pages cover ISO 9001, 13485, 14971, 17025, 22000, 45001 and IATF 16949. Workflow email reminders, action traceability and daily backups are standard. A pricing page with 5, 10, 20 and 30 user options exists, but its figures could not be read, so no price is quoted. The company lists a US representative office and gives little pharma validation content.
What isoTracker does better than MasterControl
- Pay per module rather than for a whole platform
- A 60-day trial of the full version without a card
- Concurrent licences for many occasional readers
- Landing pages for a wide list of ISO standards
Where isoTracker is a step down from MasterControl
- Price figures not readable on the pricing page
- Little validation content for pharma teams
Standout against MasterControl. It is the only tool here with a 60-day trial that keeps the data entered during it.
Best for: German-speaking organisations that run quality and ISMS in one process model.
ConSense GmbH in Aachen names three managing directors in its Impressum and is registered at the Amtsgericht Aachen. Compared with MasterControl, the centre is a process-based management system: quality, information-security management, GRC, integrated management systems, document and knowledge management, forms management and a separate GxP validation case.
Sectors listed include social services, medical, pharma, energy, transport and logistics and production, which is wider than the life-science focus of most eQMS vendors. The English version of the site returned a not-found page when checked, so evaluation material is mostly German. Prices, hosting and certifications were not read, and shop-floor inspection is outside its reach.
What ConSense does better than MasterControl
- Quality and ISMS on one platform
- A forms management module
- Sector range beyond life sciences
- An Academy and a yearly user event
Where ConSense is a step down from MasterControl
- Little or no English documentation
- No prices, hosting or certifications on the pages checked
- Not aimed at inspection or SPC on the shop floor
Standout against MasterControl. It is the only tool here that names an annual user event, ConSense EXPO, next to a training academy.
What actually breaks when you switch
The first thing that breaks is the data shape. A MasterControl export carries documents with their approval history, and a new system may accept the files but not the signatures, effective dates or links between a CAPA and the document it changed. Decide before the move what must be imported as live records and what can be archived as read-only PDFs for the retention period. Ask each vendor for a trial import using a sample of your own documents.
The second break is people and contracts. Training assignments are tied to document versions, so every employee gets re-assigned reading, and external auditors need new logins; SimplerQMS offers free Viewer licences, Qualio unlimited basic users. Check the notice period of the current MasterControl contract before signing, because running two systems in parallel for a quarter is common, and the validation of the new system has to be finished before the old one is switched off.
Does a smaller company still need a MasterControl-sized system?
It depends on what the auditor will ask for. A company preparing a first ISO 13485 audit needs controlled documents, training records, CAPA and a risk file, and Qualio, Scilife, OpenRegulatory and isoTracker all describe those parts. The wider the platform, the longer the rollout, so the question to ask a vendor is how many weeks pass before the first audit-ready procedure exists.
Orcanos quotes a go-live of 14 days for its eQMS with templates, and 24 days on average, which are vendor figures. Scilife lets a team start with documents and training and add CAPA and change control by switching to a higher tier. Both approaches shrink the first project compared with turning on a plant-wide system.
Which alternative suits a plant with inspection plans and SPC?
Babtec and CAQ AG. Babtec splits its range into quality assurance (control plans, FMEA, in-production inspection, SPC) and management systems (requirements, documents, processes). CAQ AG adds gauge management, initial sample inspection and PPAP, with interfaces named for SAP and CAD systems.
Neither publishes a price, and both are configured rather than switched on. Ask each for a reference in your own sector, since Babtec points at automotive, electronics and machinery, while CAQ AG lists automotive, medical technology, food and metalworking.
Which one to pick
For a pharma, biotech or device company that wants something close to the MasterControl scope in a validated form, start with SimplerQMS and Scilife, then add Qualio if design controls and developer-tool links matter more than a published price. Medical device startups with a small budget should read the OpenRegulatory page first, and Orcanos fits where the software team needs requirements and tests in the same system.
For a plant, choose by sector and by control over hosting: Babtec for automotive, electronics and machinery suppliers, CAQ AG when on-premises operation or deep inspection modules are needed. Cognidox suits hardware developers with a document-first process, Ideagen suits a large organisation wanting quality and EHS from one supplier, isoTracker suits a small firm adding modules, and ConSense suits German-speaking teams that combine quality with information security.
Frequently Asked Questions
That depends on the criterion. For a validated life-science eQMS with onboarding in the fee, SimplerQMS (Denmark) and Scilife (Belgium) are the closest to the MasterControl scope, with Qualio (Ireland) as a narrower option. For a medical device startup on a small budget, OpenRegulatory (Formwork) from Germany starts at no cost. For plant quality, look at Babtec or CAQ AG.
OpenRegulatory lists Free, 99 euro and 499 euro monthly plans, all plus VAT. SimplerQMS shows a Starter plan from USD 17,500 a year for up to 15 users, and Cognidox states annual subscriptions from 6,000 pounds. isoTracker has a pricing page, but its figures could not be read, so no amount is quoted for it. The remaining tools quote on request.
OpenRegulatory states France and Germany on French and German hosts, with no Amazon, Google or Microsoft cloud. Scilife offers a European data centre on request, although the platform runs on Amazon AWS. CAQ AG lets the customer choose SaaS or on-premises. For the other tools the pages checked do not name a data location, so put it in the contract.
They are listed because the directory counts the United Kingdom, Switzerland and Israel as European. Cognidox, Ideagen and isoTracker are English companies, and the UK has an adequacy decision but sits outside the EEA. Orcanos is an Israeli company in Ramat Gan. Cognidox also states a US-based parent, Recur Software Technologies Inc., which belongs in a supplier file.
None of the eleven claims a full equivalent of that bundle. CAQ AG and Babtec cover production-side quality such as inspection, SPC and FMEA, but the pages checked do not describe batch records or manufacturing execution. Plan on keeping a separate production system if you run one today.
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