SOFTWARE EVALUATION GUIDE FOR MANUFACTURERS

How to choose eIFU softwareAsk for evidence in the demo.

eIFU software evaluation criteria and supplier demo checklist

Evaluate an eIFU platform through product mappings, controlled publication, language coverage, QR access and paper requests. Write your requirements, run the same example in demonstrations and support your decision with the records shown.

Software evaluation guide · Updated 6 October 2026

Three steps to a comparable evaluation

  1. 01

    Define the initial scope

    List product counts, document types, current revisions, user groups, target markets and required languages. State expected integrations and support coverage separately.

  2. 02

    Use the same demonstration scenario

    Use the same sample product and language scope across suppliers. In a test environment, inspect missing languages, incorrect product mappings and unauthorised decisions as well as successful access.

  3. 03

    Record evidence and responsibility

    For each requirement, record demonstrated evidence, open issues, an owner and a target date. Do not hide an unmet mandatory requirement behind a total score; verify contractual and service scope separately.

Eight questions to ask an eIFU supplier

These are evaluation questions for manufacturers, not a claim that every feature in each row is available in this platform. Verify demonstrated behaviour separately from the service scope in the proposal.

Eight questions to ask an eIFU supplier
Evaluation areaQuestion to ask in the demoRecord / evidence to request
Product and document mappingsDoes reference/GTIN search find the correct product and IFU? How is an incorrect mapping identified?Sample product reference, selected document type, audience and opened file.
Review and publication authorityCan the uploader approve their own file? Does approval automatically publish it in the portal?Uploader/reviewer roles, action result and a separate publication decision record.
Language and revision scopeWhat happens when a required approved language for the same revision is missing?Product–market language list, missing-version result and decision after correction.
QR and link continuityWhich address and revision does a printed product QR open after a new file is published?Before/after product URL; domain and redirect responsibility.
User accessDo country, audience and document language selections open the correct file?Separate checks of interface and file language; product–revision access result.
Paper-request operationsWho receives the request? How are dispatch and fulfilment distinguished?Request reference, owner, target date, dispatch and fulfilment evidence.
Operations and continuityWho does what when access fails or restoration is needed?Written responsibilities, support scope, restoration procedure and test records where available.
Data and service scopeWhat are the migration/export, integration and end-of-service arrangements?Proposal specifying data scope, format, fees/limits, delivery owner and open issues.

Demo scenario: what if a required language is missing?

Suppose the approved example scope for SAMPLE-001 requires Turkish and English Rev. B. English is approved, but Turkish is missing. The eIFU Systems publication check blocks the relevant action when a required approved language is missing. Complete independent review of the missing file, then reassess the publication decision; check both language selections and the opened file revision in the portal. This fictional example is not a country-specific language rule.

Make the decision using evidence

Record each area as demonstrated, an open issue or out of scope. Resolve critical requirements before moving the relevant product scope forward. A technical demonstration does not replace assessment of content accuracy or eligibility for electronic delivery.

Publisher: eIFU Systems. This guide draws on the product’s documented publication workflow and includes supplier evaluation recommendations. It does not present test results for other providers or an independent product ranking.

Apply this checklist in a guided demonstration ↗

A pilot acceptance plan for your first product

After a supplier demonstration, test a small product scope against your own publication process. These tests are a purchasing evaluation template, not a claim that a particular supplier provides every feature. Record the expected result, demonstrated evidence and owner of each open issue.

Shared example: SAMPLE-001, Rev. A and Rev. B, with Turkish and English documents. Keep the same example across evaluations without using real customer or patient data.

  1. 01

    Reconcile the imported record

    Compare product reference, document type, revision and language records against the source inventory. Resolve missing or incorrect mappings before publication.

    Evidence: source-to-portal record comparison and a discrepancy list.

  2. 02

    Inspect the state before publication

    Open the user-facing link while Rev. B awaits approval. Write down which file should appear under the documented publication rules; test approval separately from public publication.

    Evidence: review state, publication decision and the revision shown to the user at that time.

  3. 03

    Test a missing required language

    With both languages required in the example scope, leave one approved language file missing. Observe the relevant publication check, the visible warning and reassessment after the missing file is completed.

    Evidence: required language list, missing-language result and decision after correction.

  4. 04

    Reopen the previous QR link

    After Rev. B is published, open the previously recorded QR address for the same product. Check the product, selected language and displayed revision; record responsibility for the domain and redirects.

    Evidence: before-and-after product links and the document information displayed.

  5. 05

    Follow a paper request end to end

    In a test environment, assign a sample request to an owner. Inspect dispatch and fulfilment records separately. State who acts at each step and which evidence they provide.

    Evidence: sample request reference, owner, dispatch and fulfilment records.

  6. 06

    Record acceptance and open issues

    Mark each row as demonstrated, open issue or out of scope. Do not use a total score to approve a transition while a mandatory requirement remains open; record the follow-up owner and retest conditions.

    Evidence: requirement, outcome, record reference, owner and retest date.

How should you record the pilot outcome?

Use these fields for each test: requirement · mandatory/optional · expected result · observed result · evidence reference · open issue · owner · retest date. Keep technical acceptance separate from document-content review and the product/market decision on eligibility for electronic delivery.

Plan a pilot discussion around your product scope ↗

Match supplier evidence to your intended use.

Use these questions to agree the evidence, service deliverables and acceptance responsibilities for your own scope. Record each promised document by name and confirm its availability in the proposal.

What evidence should we request from an eIFU supplier?

Define your product, document, language and user scope first. Request the release identification, configuration record, test steps and results, open issues and evidence of the publication decision for that scope. Name the documents the supplier actually provides in the proposal and acceptance plan.

Does a demonstration replace validation?

A demonstration lets you observe an expected workflow. It does not by itself establish the requirements for your use, the test evidence or the acceptance decision within your company’s quality process.

How do supplier tests differ from manufacturer acceptance tests?

Supplier tests should demonstrate defined behaviour for an identified release. Manufacturer acceptance tests should assess expected results using the manufacturer’s products, languages, roles and processes. Record the scope and responsibilities together.

What records should be kept together when a revision changes?

Keep the product and document reference, previous and new revision, document language, publication state, decision date and tested link together. Record successful results and open issues separately.

Agree validation documentation, supplier certificates and support deliverables separately with your quality team; the evaluation questions here do not establish that these items are included in the service.

Discuss your evidence and demo scope ↗

Document and record handover when changing providers

Before changing eIFU providers, agree in writing which product and document inventories, files, revision and language records, publication decisions and access links will be handed over. Reconcile the delivered records with the source inventory and test printed QR links during the transition.

  1. Freeze the inventory

    Record a dated source list with product references, document types, revisions, languages, publication status and an owner.

  2. Separate files from records

    A PDF file, its product mapping, a publication decision and an activity record are different deliverables. Specify scope and format for each.

  3. Agree delivery conditions

    Confirm format, timing, fees, excluded records and the delivery owner with the supplier.

  4. Reconcile the delivery

    Compare expected and received file/record counts, product mappings, revisions and languages. List discrepancies separately.

  5. Test printed links

    Open representative QR addresses from existing labels before and after the transition. Check domain control, HTTPS, redirects and access to the correct document.

  6. Record acceptance

    Document open issues, owners and resolution dates. Assess closure of the old service and remaining access responsibilities alongside delivery acceptance.

This is supplier evaluation advice. It does not promise automatic export, complete activity-history migration or uninterrupted access; the applicable scope depends on the verified contract.

Review QR link continuity →

Which scope and cost items should you compare in eIFU software proposals?

Compare eIFU proposals beyond the subscription amount. For the same product, document, language and user scope, request separate written details for one-time setup and migration, recurring services, support, overages and end-of-service handover. Do not assume a deliverable is included unless it is explicitly named in the proposal.

Which scope and cost items should you compare in eIFU software proposals?
Comparison areaQuestion for the supplierRecord to request in the proposal
Products, documents and languagesWhich products, files, languages, users and portals are covered? What happens if limits are exceeded?Scope inventory, quantity limits, overage conditions and excluded work.
Setup and migrationWho prepares and maps the existing document inventory? Who accepts the first publication?One-time work, deliverables, manufacturer/supplier owners and acceptance criteria.
Training and supportWhich teams receive training? What channels, hours and service scope apply to support?Training scope, support terms, additional service charges and open issues.
Domains and integrationsWho manages the domain, HTTPS and QR redirects? Are requested integrations separately priced?Domain responsibility, link management, included/excluded integrations and a separate delivery plan.
Recurring fees and extra workHow are the service period, renewal, limit increases and out-of-scope work priced?Subscription period, currency, tax treatment, renewal conditions and approval of extra work.
End of service and handoverWhich files and records are delivered, in what format and timeframe? Who maintains old QR access?Delivery scope, timing, any fees, domain responsibility and acceptance record.

Compare proposals over the same evaluation period. Keep one-time work, recurring fees and conditional extras in separate rows; do not directly add amounts with different currencies or tax conditions.

This is a proposal evaluation template, not a price list or a statement that every item is included in eIFU Systems services. The verified written proposal determines prices and commitments.

Review document handover at the end of service →

Discuss your product and language scope ↗

Assess QR access separately from the file

Ask how the product link behaves after a revision changes. Record conditions for keeping the same product record, link mapping and domain control. Check address, redirect and TLS dependencies for QR codes already printed on your products.

Make the proposal scope explicit

Ask for written product/document/language limits, migration, setup, training, domain arrangements, support hours and responsibilities. Verify integration, data export, SLA and independent certification expectations with the supplier’s evidence; this guide does not mean eIFU Systems automatically provides them.

Prepare your setup inventory →

Explore multilingual IFU management →

Review the publication workflow →

Questions about choosing eIFU software

Is a PDF hosting page enough?

If you need controlled IFU publication, assess product mappings, reviewer/publisher authority, revisions, required languages and request tracking alongside file hosting. Your team separately determines eligibility for electronic delivery for each product and market.

What should we test first in an eIFU demonstration?

Start with one sample product and approved language scope. Check access to the correct file, the relevant publication block when a required language is missing, and that approval alone does not publish a file in the portal.

Does software alone establish regulatory compliance?

No. Evaluate software features together with the manufacturer’s product scope, risk assessment, document content and applicable obligations. This guide is not a compliance certificate or legal opinion.

How do we identify the best eIFU software?

There is no single best choice for every manufacturer. First define mandatory product, language, publication, access and operational needs; compare demonstrated behaviour, scope, service responsibilities and open issues.

Should we send confidential IFU files for the demonstration?

Product range, document languages and target markets are enough for the first discussion. Plan the workflow using sample data; do not add confidential documents or patient information to the contact form.

LET’S DISCUSS YOUR REQUIREMENTS

See the platform with your team.

We will walk through document access, revision management and multilingual publishing around your product range and markets.

Chat on WhatsApp ↗

DEMO REQUEST

Tell us what you need.

This form prepares a WhatsApp message. Your request is sent only when you send it in WhatsApp. Do not include patient information or confidential documents. Privacy information (Turkish)