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Industrial-Grade Data Security & Compliance

At FactoryFour, we understand different sectors of manufacturing require the unique storage and transfer of data. We are committed to providing fully-compliant manufacturing software and educating manufacturers on best-practices and risk factors to avoid non-compliance in the midst of a vast and stringent regulatory landscape.

Our Certifications

  • ITAR EAR ITAR & EAR

    ITAR specifically regulates the import and export of defense-related products, data and services that appear on the United States Munitions List. EAR is a parallel regulation that focuses on dual-use items available for commercial sale and government use, appearing on the Commercial Control List. Both are strict regulations aimed at preventing sensitive data from being accessible by foreign nationals, and software providers must structure their applications specifically to achieve this.

    FactoryFour is ITAR and EAR compliant, hosting our applications on a separate, compliant server and engaging in best practices to avoid violation.

  • FDA 21 CFR Part 11 EU GMP Annex 11 FDA & EU GMP

    FDA 21 CFR Part 11, and its sister compliance EU GMP Annex 11, require organizations to implement controls, audit trails, electronic signatures, and documentation for software that processes the electronic data the FDA requires them to maintain. This commonly applies to organizations producing pharmaceuticals, medical devices, biotech and biologics.

    FactoryFour has implemented all the necessary administrative and technical procedures to be compliant, and cover IQ (installation qualification) and OQ (operational qualification). FactoryFour Customer Success can provide recommendations to your personnel for PQ (performance qualification) required to incorporate FactoryFour into processes covered by Part 11 or GxP.

  • HIPAA HIPAA

    Organizations that handle patient protected health information (PHI) in the United States are subject to HIPAA. To be compliant with HIPAA, software applications that handle PHI need to have specific network and process security measures in place, such as encrypting data in transit and at rest. FactoryFour works with manufacturers who fall under these regulations to securely store, send and receive PHI while managing production.

  • GDPR GDPR

    GDPR applies to organizations operating within the EU as well as any organizations outside of EU providing goods or services to the EU. Under GDPR, companies that collect personally identifiable information (PII) such as names, addresses, and more are held liable to protect it from misuse or exploitation. Any PII handled within FactoryFour is secure and compliant under GDPR.

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ITAR EAR

ITAR & EAR


For manufacturers that need an ITAR and EAR compliant solution, FactoryFour provides you with:

  • Fully compliant data storage hosted on AWS GovCloud restricted to the US.
  • Secure data encryption in transit and at rest.
  • Traceable, electronic audit trail of all actions performed or data entered.
  • Sequestered team of US persons on FactoryFour Customer Success staff who have been trained in safe handling of Export Controlled and ITAR governed data.
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FDA 21 CFR Part 11 EU GMP Annex 11

FDA 21 CFR Part 11 / EU GMP Annex 11


For manufacturers that require a solution compliant with FDA 21 CFR Part 11 or EU GMP Annex 11, FactoryFour provides you with:

  • Functionality for a fully traceable and electronic audit trail, including compliant electronic signatures and quality forms.
  • Granular access controls to ensure only approved personnel can perform specific actions such as approvals.
  • Services for Installation Qualification (IQ) and Operational Qualification (OQ), as well as assistance for your personnel with defining Performance Qualifications (PQ) via User Acceptance Tests (UAT).
  • Device History Records (DHR) with unique batch identification, lot traceability, and production records.
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HIPAA GDPR

HIPAA / GDPR


For manufacturers handling PHI or PII, FactoryFour offers a HIPAA and GDPR compliant solution that provides you with:

  • Fully compliant data storage with secure data encryption in transit and at rest.
  • Robust order management tools that allow secure handling of PHI and PII.
  • Functionality to maintain compliance such as granular access controls, activity and audit logs, and automatic sign-off for unattended devices.

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