Skip to main content
    QHSEtech
    Updated 1 October 2026
    Research-based buyer guide

    NCR Software: Intelex and MasterControl Compared

    An NCR workflow needs to record the problem, affected scope, containment and authorised disposition before the team decides what further investigation is needed. Compare Intelex and MasterControl around your real product and process records, with CAPA escalation tested separately from simple task completion.

    Jump to the 32 products

    Editorial responsibility: Dimitris Mitsios (Founder of The QHSE Standard; product marketing at Tekmon) · Tekmon pays for sponsored placements on this site (disclosure) · How pages are made · LinkedIn

    On this page (18 sections)

    Intelex vs MasterControl: pricing, offline scope and fit

    Status labels from each product's sourced record; open the profile for the evidence, conditions and dates. Research dates belong to each product; this table does not establish a fresh source check or a performance ranking.

    Categories describe software types; processes describe work to manage. Category membership does not confirm a specific feature or included module. Check the quoted plan and workflow with each vendor.

    Scroll horizontally on a small screen.

    Offline classification, pricing headline and trial status; full evidence on each profile
    ProductWorks offline?PricingFree trial
    Intelex
    +2 additional categories

    Profile sources: 3 October 2026. Targeted recheck: 19 September 2026.

    		Documented offline workflow

    US$44/user/month for Safety Essentials; minimum 25 users, billed annually

    Pricing context    		Trial or demo on request
    MasterControl
    +1 additional category

    Profile sources: 3 October 2026. Targeted recheck: 26 September 2026.

    		Not yet classified

    No verified starting price. Contact vendor.

    Pricing context    		Not established

    Profile links contain the primary sources and unresolved limitations. Vendor documentation is not hands-on testing. AI-assisted explanations may be incomplete and do not replace primary documentation or a demo.

    Read the comparison at the right level

    The table summarises the broader product evidence. It does not verify every module discussed below, disconnected approvals or inclusion in the quoted plan. Unknown pricing means request a scoped vendor quote; an unverified capability is an open question, not proof that the feature is absent.

    What to demonstrate before buying

    StageProposed testEvidence to retain
    IdentifyLog the specification and what was actually measuredSpecification revision, lot, serial or asset number, plus the inspection evidence
    ContainHold the suspect material or work apart from good stockAffected scope, the person responsible and the hold's review status
    DispositionPick the treatment your procedure permitsWho authorised it, why, and the record of the work that carried it out
    EscalateJudge whether the finding recurs or is serious enough to investigateThe reason a CAPA was opened, or the other follow-up chosen instead
    CloseCheck the finished treatment before the record shutsAny restriction that remains and the reviewer's decision

    A nonconformance from detection to closure

    This sequence shows where an NCR is contained, given a disposition and either closed or escalated into a separate CAPA record.

    Nonconformance flowEight steps across three roles from detection to closure, with a reinspection return path and a bypass that skips the CAPA step when no escalation is needed.FinderArea ownerQuality reviewerReinspection failsNo CAPA neededStep 1Detect and reportRequirement, observedresult, lot or asset,evidence.Step 2Contain the suspectitemScope, location,quantity already movedon, who holds it.Step 3Assess thenonconformanceSeverity, affectedscope and who must betold.Step 4Decide thedispositionTreatment chosen,approver and writtenreason.Step 5Carry out thedispositionWork done and thereinspection result.Step 6Decide whether toescalateThe rule that fired,or why no CAPA wasopened.Step 7Open a linked CAPAOnly when escalated; aseparate record thatstays linked.Step 8Verify and closeRemaining restrictionsand the closingreviewer.
    Whether the CAPA step happens depends on your escalation rule. The nonconformance keeps a link to any CAPA it opens; dashed arrows are return paths or bypasses.
    Text version of this diagram
    1. Step 1. Detect and report. Owner: Finder. Requirement, observed result, lot or asset, evidence. Then step 2.
    2. Step 2. Contain the suspect item. Owner: Area owner. Scope, location, quantity already moved on, who holds it. Then step 3.
    3. Step 3. Assess the nonconformance. Owner: Quality reviewer. Severity, affected scope and who must be told. Then step 4.
    4. Step 4. Decide the disposition. Owner: Quality reviewer. Treatment chosen, approver and written reason. Then step 5.
    5. Step 5. Carry out the disposition. Owner: Area owner. Work done and the reinspection result. Then step 6.
    6. Step 6. Decide whether to escalate. Owner: Quality reviewer. The rule that fired, or why no CAPA was opened. Then step 7.
    7. Step 7. Open a linked CAPA. Owner: Quality reviewer. Only when escalated; a separate record that stays linked. Then step 8.
    8. Step 8. Verify and close. Owner: Quality reviewer. Remaining restrictions and the closing reviewer. End of the sequence.

    Feedback loops

    • From step 5 (Carry out the disposition) back to step 4 (Decide the disposition): Reinspection fails.
    • From step 6 (Decide whether to escalate) back to step 8 (Verify and close): No CAPA needed.

    Containment comes before the disposition decision

    An NCR first has to fix a boundary: which lot, serial range, work order or asset is suspect, where it sits now and who holds it. Quarantine is a real status, so test whether the software sets an on-hold status that your ERP or warehouse system respects, or only describes one in a text field. Record the quantity that has already moved downstream as well. That figure decides whether you are running an internal sort or notifying a customer.

    Who may authorise use as is, rework, repair, scrap or return

    NASA's hardware quality requirement lists scrap, rework, repair, return, downgrade and use as is as example dispositions, and expects projects to define which nonconformances reach a review board and how the technical authority concurs (NPR 8735.2C, 6.3.1). FDA's QMSR preamble is explicit about the riskiest option: acceptance by concession is allowed only with justification, approval and compliance with applicable requirements, and FDA expects scientific evidence behind the justification and concessions that stay exceptional (QMSR final rule).

    Rework is narrower than it sounds. The 21 CFR 820.3 definition covers action taken before release for distribution, and the preamble says action after distribution is not rework. Each treatment therefore needs its own authority list, with an approver, written justification and, for rework, a reinspection result. This is buyer context, not legal advice.

    Review boards and lot traceability

    For significant safety, technical or programme risk, the NASA text sends the nonconformance to a board such as a materials review board. Members must cover quality assurance, process control, engineering design, reliability and programme risk, with no minimum headcount, and the board sets controls for any non-standard rework or repair it approves (NPR 8735.2C, 6.3.1 and 6.3.3). Software should let you add reviewers by discipline, keep a dissent and attach the approved rework instruction.

    On traceability, 21 CFR 820.10 points to unique device identification (part 830) and traceability procedures (part 821) where they apply. Whatever your sector, test whether one query lists every lot, serial number and customer shipment a single NCR touches, including material already consumed downstream.

    Deciding whether an NCR needs a CAPA

    FDA's preamble says nonconforming product should be investigated to a depth matching its significance and risk, sometimes in depth and sometimes by a simple investigation followed by trend analysis. Its example is a moulding process whose usual 5 per cent rejection rate rises to 10 per cent, which calls for investigating the process (QMSR final rule). Turn that into two configurable triggers, a severity class that always escalates and a count of same-code NCRs in a rolling window, with thresholds you set. Store the rule that fired, or the reason for not escalating, and keep the NCR linked to the CAPA while it runs.

    What the software must hold at each NCR decision

    DecisionAuthority and justification to recordLink or check to keep
    Quarantine or holdWho placed the hold, its scope and who may release itA status that inventory and shipping respect, and the quantity already moved on
    Use as is (concession)A named approver, written justification and any customer or regulator approval your contract requiresA concession count by part and supplier, so exceptions can be monitored
    Rework or repairThe approved instruction, standard or non-standard, and who is qualified to perform itA reinspection result, with a failed attempt returning to the disposition decision
    ScrapQuantity, authoriser and evidence of disposalThe inventory write-off and cost reference
    Return to supplierReturn authorisation and the supplier's notificationThe supplier's reply on the same record, visible only to that supplier
    CAPA or no CAPAThe escalation rule that fired, or the reason for stopping at correctionA two-way link so neither record closes over unfinished work in the other

    Intelex: named nonconformance application

    Intelex names a Nonconformance Reporting application, which its catalogue describes as handling internal and external nonconformances together with corrective and preventive action plans. Action Plan Management and Corrective Action Reporting are listed as separate applications, so ask which of the three your quote contains. Then run one of your own incoming-batch or supplier findings through it and watch whether the disposition and the follow-up stay connected to the original finding.

    MasterControl: process scope needs a current demonstration

    MasterControl documents quality-event workflows, including nonconformance and CAPA scope. Its nonconformance page describes a route from initiation through investigation and recommendation to disposition and management approval, with follow-up notifications, overdue escalation and the option to launch a linked CAPA (profile check of 28 September 2026). Disposition authorities and material status controls are not settled by that description, so ask to see them configured. Ask for the package by name together with its configuration and any validation-support proposal, and trace disposition and escalation through a few of your own records. Current vendor documentation is linked from the refreshed profile; the older process manual in the sources is background for one version only.

    A practical demo scenario

    Use a rejected incoming batch that arrived as two separate deliveries from one supplier. Ask the vendor to relate the two findings while leaving each delivery's own traceability untouched, to limit the disposition step to an authorised role, and to log a rework attempt that fails reinspection. Then add a supplier reply and confirm that the supplier user sees nothing beyond their own records.

    Worked example (fictional): NCR-0231, a thread-gauge failure

    1

    Detect

    Invented for this guide. Final inspection of lot L-5521, 1,200 stainless fittings, finds 9 of a 125-piece sample failing the go gauge. The inspector logs the drawing revision, the gauge identifier and the nine serial numbers.

    2

    Contain

    L-5521 and the two lots cut from the same machine setup, L-5522 and L-5523, go on hold. Shipping records show 300 pieces of L-5521 already at one distributor, so those 300 are listed as an affected customer lot and the remaining 900 are held.

    3

    Decide the disposition

    A three-person board of quality, production engineering and sales meets. The 900 held pieces are gauged one by one and rejects scrapped. The board will not accept the shipped 300 as is without the customer's written concession, so a request goes out with the measurement data and each member's vote is recorded.

    4

    Apply the CAPA rule

    The invented rule opens a CAPA when the same defect code appears on three NCRs within 90 days, or at once for a safety-class defect. NCR-0231 is the third thread NCR on that machine in 62 days, so the software should open and link a CAPA with the rule recorded as the reason.

    5

    Close only when everything is resolved

    The customer refuses the concession and 300 replacements ship. The NCR should refuse closure until every lot has a disposition, the shipped quantity is resolved and the CAPA link exists. If a later lot fails the same gauge, the record reopens or links forward without losing these decisions.

    Pricing and value: compare the complete scope

    Ask for prices covering shop-floor reporters, quality reviewers and supplier access, including any portals sold separately. Quote ERP identifiers, attachment migration and retention as their own lines. A public entry-plan price for a broader platform does not establish what an NCR deployment costs.

    Researched products whose records name nonconformance handling

    The comparison above covers two products by request. This list is not limited to them: one rule is applied to every researched profile, and a product is listed when it carries a quality-side tag and a sourced capability that names nonconformances, nonconformities or NCRs. Some cards are admitted by a dedicated nonconformance record and others by a sentence about audit findings or risk records that link to one, so read the capability printed on the card before assuming it covers containment and disposition, then run the demonstration steps on this page against it.

    Tekmon pays for a sponsored placement (above); its place in this list follows the same rule as every entry. How lists are ordered

    Same rule for every product: tagged “Quality Management”, “CAPA Management”, “Nonconformance” or “Nonconformance Management”, with a sourced nonconformance capability in its record, or one the vendor stated to us, labelled as vendor-stated. 32 qualify; the first 8 are shown, then the other 24.

    Also meet the rule, in the same order (24)

    Questions to include in your RFP

    Can two reports about the same problem be linked while each keeps its original record?
    Can the authority to disposition vary by site, product or risk class?
    What happens when an offline observation was made against a superseded specification?
    Can a supplier add evidence without being given internal review permissions?

    Four questions for the vendor on the NCR step

    Does an on-hold status on a lot or serial range stop transactions in our ERP or warehouse system, or does it only display a flag?
    Can we name different approvers for use as is, rework, repair, scrap and return, and will the system refuse an approval from anyone outside that list?
    When rework fails reinspection, does the record return to disposition with the first attempt kept, and does the lot genealogy show both?
    Can the escalation rule count same-code NCRs over a rolling period, and where is the reason recorded when no CAPA is opened?

    Related Guides

    CAPA Management SoftwareBest Audit Management SoftwareQuality Management SoftwareSupplier Management SoftwareComplaint Management SoftwareISO Management Software Guide

    Sources and evaluation method

    7 sources, checked 19 Sep – 1 Oct 2026

    Module sources checked 19 September 2026; the MasterControl nonconformance page is as recorded on its profile, checked 28 September 2026. Requirement and guidance text was read on 1 October 2026: Part 820 as published on eCFR in its 29 September 2026 version, the QMSR preamble and NASA's chapter 6 (an aerospace programme requirement, cited only as an example of board practice). Pricing and offline evidence keep the review dates on each product profile. The guide rests on vendor documentation and public requirement text, with no hands-on testing or customer testimony. The demo tests and the worked example are editorial suggestions rather than verified product performance, and nothing here is legal advice.

    Requirement and guidance sources

    Product sources

    Our framework considers functional depth (25%), usability and adoption (20%), implementation and TCO (15%), integrations and API (15%), security and trust (15%), and customer voice (10%). We have not assigned numerical scores here. AI-assisted explanations may be incomplete and do not replace primary documentation or a demo. Evaluation methodology.

    Software categories to explore

    Use this Process to define the work, then explore these software types. Confirm the exact workflow and module with each vendor.

    See all software categories

    More related guides

    Frequently Asked Questions

    Should every NCR generate a CAPA?
    Decide with your own approved escalation criteria. The software should store the decision and its reason instead of quietly turning every report into the same investigation. Show it handling both a one-off correction and a recurring problem that escalates.
    Who can raise an NCR?
    That follows from permissions, user roles and the application you buy. Ask Intelex and MasterControl to show operator, auditor and supplier access one at a time. Mobile access does not imply anonymous reporting, and external accounts may not be free.
    What is the difference between NCR and CAPA?
    The NCR records the nonconformity and how it was handled. A CAPA is a separate, structured investigation where your process calls for one. Keep the two linked so that closing one cannot hide unfinished work in the other.
    Who can approve a concession or use-as-is decision on a nonconforming product?
    The authority comes from your procedure, your customer contract and any regulation, not from the software. FDA's QMSR preamble says acceptance by concession needs justification, approval and compliance with applicable requirements, so configure a named approver list and a justification field, then test that other users are refused. This is not legal advice.
    Does rework still apply once a product has shipped?
    For medical device manufacturers, the 21 CFR 820.3 definition limits rework to action before release for distribution, and FDA's preamble says action after distribution is not a type of rework. For a shipped lot the record should show a different outcome, such as customer notification or return, rather than reusing the rework status. Check which terms your regulator and customers use.