Dot Compliance review

About the price: No price on the vendor site or Salesforce AppExchange (Sep 2026). A vendor-supplied software-directory listing (SourceForge, 2023–2026) says it starts at $10,000 a year with validation included; users and edition not stated. Implementation services exist; whether they cost extra isn't published.

What is Dot Compliance?

Dot Compliance has built electronic quality management software since 2015.¹² Its website lists entities in Israel, the UK and the US.³ The company raised a $23 million Series B in 2022 and a $17.5 million extension in April 2024, for $50 million in total.⁴² It says it has more than 500 customers in 30 countries.¹

The eQMS runs natively on Salesforce. Customers don’t need their own Salesforce licence, because it’s included.⁵ The selling point is a system that arrives pre-built and pre-validated, with standard workflows already configured.⁵

Dot Compliance has sold this in editions:⁶⁷

• QMS Xpress (later eQMS Xpress): the core processes, including document control, training, change control, CAPA, complaints, audits, risk and supplier quality.
• Compliance Xpand: adds manufacturing and specialty areas.
• Enterprise Xact: tailored configurations.

The edition pages now redirect to the homepage, which sells the eQMS by module.⁵ The help center also lists modules for design control, bill of materials, batch release and clinical management.⁸ These are editions and modules of one product, so this review scores it as a single product.

Who Dot Compliance is for

The strongest fit is a company that needs GxP processes, such as deviations, batch records and equipment management, alongside device quality.⁵ Most Capterra reviewers work in pharma or biotech.⁹

Medical device makers are a clear second market. The vendor has a device page and a device complaint module,¹⁰¹¹ and publishes device case studies:

• EyeQue, a 50-person device company.¹²
• Nanox, with more than 160 employees.¹³
• Pi-Cardia, a heart-valve device maker.¹⁴
• Omega Diagnostics, an IVD manufacturer.¹⁵
• Dandy, a dental technology company with more than 1,500 employees.¹⁶

Software teams should look elsewhere. We found no IEC 62304 features and no Jira or Git integration, and the design-control manual is only available to customers.⁸¹⁷

Dot Compliance pricing

Dot Compliance doesn’t publish prices. Its site has no pricing page and sends visitors to a demo request, and its Salesforce AppExchange listing says the same.⁵¹⁸

The only figure we found is on a software-directory listing (SourceForge). It says prices start at $10,000 a year with validation included, and hasn’t changed in snapshots from January 2023 to February 2026.¹⁹ The listing doesn’t say how many users or which edition that covers. It also gives the wrong founding year, so treat it as a rough floor rather than a quote.¹⁹

Capterra also lists pricing as “contact vendor”, and G2’s pricing page shows no prices.²⁰²¹ On Capterra, six reviewers praise the value for money, while three say licences are costly, in part because of the Salesforce platform.⁹ None of them gives a figure.

The validation documentation package is included in the subscription.²² Dot Compliance also sells consulting and implementation services, but doesn’t say whether they’re mandatory or cost extra.²³ Without two independent price signals, we can’t estimate what a 10-person team would pay.

Features

Document control, records and training

Documents are edited in Office 365 or Google Docs with check-in and check-out. The system tracks lifecycles and periodic reviews, and stamps PDFs with headers and watermarks.²⁴ Approving a document can trigger training for the roles that need it.²⁴ Training supports a role-based matrix, read-and-understood sign-off, exams with passing scores, on-the-job and classroom training, and SCORM courses.²⁵ Pi-Cardia describes using read-and-understood, classroom and on-the-job training with effectiveness checks.¹⁴

Design controls and risk

A Design Control module exists: it’s in the help center, and Omega Diagnostics deployed it.⁸¹⁵ It doesn’t appear in the core Xpress process lists, and its manual is customer-only.⁷¹⁷ Risk management supports FMEA with risk priority numbers, hazard traceability matrices, and initial and residual risk. That description comes from the vendor’s product pages rather than a manual.²⁶ We found no documented traceability from requirements to risks to tests, and no design history file export.

CAPA, complaints and nonconformance

CAPAs link to the deviation, complaint or audit finding that started them. Root-cause forms support methods such as 5 Whys and fishbone diagrams, and effectiveness checks are built in.²⁷ Deviations and nonconformances have severity levels and can be escalated to a CAPA.²⁸

Version 5.2 added a medical device complaint process covering investigations, product returns, recalls, assessments and regulatory reporting.¹¹ The vendor says the system can generate US MDR and EU MIR forms for electronic submission.²⁹ Its subprocessor list names an optional FDA eMDR gateway.³⁰ We couldn’t read a manual that shows this reporting workflow.¹⁷

Suppliers, audits and change control

Supplier features include qualification, an approved supplier list, scorecards and supplier corrective action requests.³¹ Suppliers can respond through a community site, which needs external licences.³¹ Audits cover annual schedules, checklists, findings that lead to CAPAs, and audit reports.³² For change control, the product pages describe risk-based impact assessments and ordered action items.³³ Dandy uses the change-control module, including Gantt planning.¹⁶

AI

All solutions include Dottie AI, an assistant with configurable agents for research, review and turning documents into protocols.³⁴³⁵ Its queries are processed by OpenAI and Google Cloud in the US.³⁰

What users say

On G2 in September 2026, Dot Compliance has 4.0/5 from 95 reviews, with ease of use at 8.0/10 and quality of support at 8.5/10.³⁶ On Capterra it has 4.4/5 from 94 reviews.⁹

• Ease of use cuts both ways. More than a dozen Capterra reviewers call it user-friendly or intuitive. A similar number report a learning curve, crowded home screens or too many clicks.⁹
• Salesforce limits. Several reviewers say deeper changes need Salesforce-level work, or mention platform limits such as dashboard size and licence types.⁹
• Support is mostly praised; two reviewers found it slow.⁹
• Rollout effort. Four reviewers say onboarding took longer than expected or needed internal effort.⁹ A device-company VP of quality rates it 3/5, citing weak documentation and mobile use.⁹

We found no first-hand user reports on Reddit. Posts there only mention Dot Compliance on evaluation shortlists.³⁷³⁸

All 95 G2 reviews were read in October 2026: 97% are labelled by G2 as invited by the vendor or incentivized, and 28% of them arrived within a single six-week window.³⁹ Because invited and burst reviews tend to skew positive, our usability, support and sentiment scores are capped at 8 rather than taken at face value.

Security, hosting and validation

Dot Compliance says it is certified to ISO/IEC 27001, ISO/IEC 27017, ISO 9001 and ISO/IEC 42001.⁵ We found no SOC 2 statement. Customer records are stored on Salesforce, and the customer chooses the Salesforce region.³⁰ PDF and AI services run on AWS in Frankfurt.³⁰

The subprocessor list is public, but we found no public data processing agreement; a services privacy policy is available on request.³⁰⁴⁰ Electronic signatures record the meaning of the signature and a time-stamped audit trail, and login uses multi-factor authentication.²² The vendor says every solution comes with a validation package.⁵ Its contents aren’t public.

Buying and contract terms

• Trial: the homepage’s free-trial button leads to a request form, and the trial is “subject to pre-qualification”.⁴¹ The site’s older free-trial page now only offers a demo.⁴² The AppExchange listing still advertises a 14-day trial.¹⁸
• Term and export: we found no published minimum term, renewal terms or process for exporting your data at the end of the contract. The website terms cover only use of the website.³ Integrations use Salesforce’s APIs, which the vendor calls “standard APIs”.²⁹
• Time to go live: device case studies range from under 30 days at Dandy and six weeks at Nanox to three to four months at Pi-Cardia.¹⁶¹³¹⁴ The AppExchange listing says the pre-configured system comes with sample SOPs.¹⁸
• Price increases: because neither prices nor customer terms are public, there’s no escalator or renewal cap to check, and no price history on the vendor’s own site.³¹⁸ The only figure, the directory listing’s $10,000 starting price, is the same in snapshots from 2023 to 2026.¹⁹ We found no user reports of renewal increases.⁹ Ask for a written cap on renewal increases.
• If the vendor closes or is sold: we found no public commitment to return your data or place it in escrow in that case.³ Ask for one in the contract.

Company and ownership

The company behind the product is Dot Compliance Ltd, an Israeli private company (no. 514055342) registered in Rehovot. The Israeli company register shows it was incorporated in November 2007 and is active, with its last annual report filed for 2024.⁴³ The vendor dates the business to 2015.¹ The US headquarters is in Phoenix, Arizona.¹⁸

It is venture-backed. Israel Growth Partners led the $23 million Series B in July 2022, with Vertex Ventures and TPY Capital also investing.⁴⁴ IGP and Vertex co-led the $17.5 million extension in April 2024, which brought total funding to $50 million.² Its founder is chief executive.⁴⁴ The vendor’s press releases announce no acquisitions or changes of ownership.⁴⁵ Its accounts aren’t public.

Verdict

Shortlist Dot Compliance if you need GxP processes such as deviations, batch records and equipment alongside device quality, and want a pre-validated system live within weeks to a few months. Look elsewhere if you build software, need design controls you can inspect before buying, or want published prices and exit terms.

Visit the Dot Compliance website (made by Dot Compliance Ltd.)