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Home / Trust Center Montrium Trust Center Get security from the ground up – backed by our team of industry experts, and proactive compliance trusted by start-ups and large enterprises. Uncompromising commitment to quality We have a strong "walk the talk"mentality here at Montrium, meaning we hold ourselves accountable to live up to the same standards our customers strive to achieve. That means maintaining a leading quality system that governs how our organization operates and delivers our platform to customers. ISO aligned quality system We’ve engineered our quality system to ensure we provide the best possible service to our customers while remaining compliant with the regulations you’ll be held to schedule for its effective procedural documents. A background in testing excellence We’ll never release something that isn’t ready to be used by a customer and you can trust every new feature has been tested at every milestone of development. Regular customer audits We regularly support ongoing audits from our customers putting our quality system, processes and our team to the test throughout the year. If you need to schedule an audit, please reach out to your Montrium representative. Proactively safeguard your data We understand how important your data is to you. We put the industry's best technology resources to work to ensure it always stays safe. Modern security operations, data encryption and intelligent system monitoring provide you with secure but accessible vault with all of the security features your tech team needs to sleep at night. Geo-replicated data backups Trust that your data remains available to you at all times with backups being performed daily, weekly and monthly as well as regular restoration tests and formal disaster recovery testing. Regular penetration testing We undergo regular 3rd party penetration testing to ensure our security practices meet current industry best practices and standards for threat protection. Modern encryption Logically isolated databases and AES256 and TLS1.2 data encryption at rest and in transit keep your data safe from unwanted perps. Controlled & restricted access Maintain a VIP guestlist to your data with advanced access restrictions all the way down to the infrastructure and servers with MFA and modern access practices. Advanced threat monitoring An advanced threat monitoring system provides real-time security alerting as well as providing multiple levels of web application firewall (including IDS/IPS functionality) and centralized malware protection. Compliance baked in Montrium protects customer data through rigorous security measures and compliance practices. All personnel with access to sensitive data are thoroughly vetted, maintain strict confidentiality, and receive ongoing security training. Testing protocols include penetration testing, vulnerability scanning, and code analysis. Cloud environments leverage Microsoft Azure's security features with data isolation, encryption in transit and at rest, and continuous monitoring aligned with SOC 2 standards. FDA 21 CFR Part 11 Montrium systems meet FDA 21 CFR Part 11 requirements through secure user access, comprehensive audit trails, and electronic signatures that are uniquely assigned, securely linked to records, and protected against unauthorized use. EudraLex Volume 4 Annex 11 Montrium products align with Annex 11 principles for computerized systems in GMP-regulated environments. Solutions support data integrity standards, provide secure audit trails, and enforce strict access controls through a risk-based validation approach. SOC 2® Type I Montrium successfully completed the AICPA SOC 2 Type I audit, confirming our information security practices meet SOC 2 standards for security. Audit support Montrium facilitates vendor qualification audits through transparent access to documentation and compliance evidence. We also support customers during regulatory inspections by supplying compliance documentation and responding promptly to inquiries. ISO 9001:2015 QMS Alignment Montrium's Quality Manual and procedural documents satisfy ISO 9001:2015 requirements for quality documentation, policy, and objectives. GDPR Montrium has implemented appropriate technical and security processes to ensure GDPR compliance. Leading infrastructure architecture Montrium leverages the industry's most modern cloud infrastructure to provide scalable solutions to life sciences that are secure and compliant. Montrium uses Microsoft Azure as it’s primary cloud infrastructure provider to meet our customers growing needs, providing a tech stack and solution set that is second to none. Microsoft Azure and the Montrium platform proactively safeguards your data and streamlines compliance with the most comprehensive compliance coverage of any cloud service provider with over 90+ compliance offerings. You control data privacy Your data, powering your experiences, controlled by you. We’ll never hold your data hostage, nor will be ever use it for marketing or advertising purposes so you can feel confident about where your data is stored and secured. New Add-On: ICH E6(R3) is here. See how eTMF Connect keeps you ready. Learn more Get the latest news and product updates delivered straight to your inbox. Thank you! Your submission has been received! Oops! Something went wrong while submitting the form. Montrium eTMF eTMF ConnecteTMF Connect features NEW Risk & Oversight Montrium RIM RegDocs ConnectRegDocs Connect features Montrium QMS Quality ConnectQuality Connect features Modules Document controlTraining managementCAPA managementChange control Platform overview Platform overviewPricingMontrium FAQTrust centerBook a demo Acrobat Sign Validation Services Adobe Acrobat Sign validation servicesFree Adobe Acrobat Sign validation pack Company AboutContact usNewsroom Resources BlogThe State of AI in Clinical QualityeTMF Buyer's GuideDemo centerResource centerCustomers success storiesPodcastsWebinarsEvents Contact Montrium Headquarters 507 Place d’Armes, #1500 Montreal, QC H2Y 2W8, Canada +1.514.223.9153 Montrium Europe SRL Rue de la Pépinière, 14-1 1000 Brussels, Belgium +32.2.808.3008info@montrium.com Contact Montrium Headquarters 507 Place d’Armes, #1500 Montreal, QC H2Y 2W8, Canada +1.514.223.9153 Montrium Europe SRL Rue de la Pépinière, 14-1 1000 Brussels, Belgium +32.2.808.3008info@montrium.com Montrium Inc. All rights reserved, 2026 Consent PreferencesTerms and ConditionsPrivacy Policy EN FR Montrium eTMF eTMF ConnecteTMF Connect features Montrium QMS Quality ConnectQuality Connect features Modules Document controlTraining managementCAPA managementChange control Platform overview Platform overviewPricingMontrium FAQTrust centerBook a demo Montrium RIM RegDocs ConnectRegDocs Connect features Resources The State of AI in Clinical QualityDemo centerResource centerPodcastsWebinarsBlog Montrium by industry Non-profitMedical deviceCROPharma / Biotech Montrium by team Clinical operationsRegulatory affairsQuality and complianceIT & security Company AboutContact usNewsroomEvents Partners PartnersTechnology partnersCo-marketing partnersService partners Acrobat Sign Validation Services Adobe Acrobat validation servicesFree Adobe Acrobat validation pack Contact Montrium Headquarters 507 Place d’Armes, #1500 Montreal, QC H2Y 2W8, Canada +1.514.223.9153 Montrium Europe SRL Rue de la Pépinière, 14-1 1000 Brussels, Belgium +32.2.808.3008info@montrium.com Socials Montrium Inc. All rights reserved, 2026 Terms and ConditionsPrivacy Policy