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مركز الامتثال

Audit-Ready Cold Chain Monitoring for Pharma, Food & Logistics

Data integrity is non-negotiable. Seemoto transforms cold chain monitoring into an audit-ready compliance asset, engineered to meet the strictest global standards.

أهمية الامتثال

In regulated industries, data accuracy and traceability are critical. We deliver secure, auditable, and transparent data every step of the way.

5-Year Data Retention

Secure cloud archiving meets long-term pharma and food safety retention clauses.

Audit Trail

Fully traceable logs of every user action, alarm, and corrective measure.

Calibration

Factory-calibrated sensors with EN 13485 accuracy.

Zero Data Loss

Gateways buffer data during outages to ensure continuous records.

لمحة سريعة عن المعايير

Seemoto supports the most demanding regulatory frameworks across pharma, food, and logistics.

قياسيمحور التركيز الرئيسيSeemoto Capability
GDPسلامة سلسلة التوريد الصيدلانيةContinuous monitoring, deviation reports & route validation for storage and transport
GMPManufacturing Quality ControlValidated environmental data, real-time deviation management & quality system integration
EN12830Temperature Recording AccuracyClass 1 certified TS & THS sensors, IP68-rated, -196°C to +150°C range
نظام تحليل المخاطر ونقاط التحكم الحرجةFood Safety Hazard PreventionAutomated CCP monitoring, instant hazard alerts & digital history logs
هيئة الغذاء والدواء الأمريكية 21 CFR الجزء 11Electronic Records & SignaturesRole-based access, electronic signatures & unalterable time-stamped audit trails

Compliance Standards in Detail

Each standard addressed with purpose-built monitoring, reporting, and validation capabilities.

ممارسات التوزيع الجيدة

Ensure product integrity across the entire supply chain. Seemoto provides continuous, validated monitoring for storage and transport, fully aligning with EU GDP guidelines (2013/C 343/01) for temperature-sensitive pharmaceuticals.

ممارسات التصنيع الجيدة

Maintain strict environmental control in production areas and cleanrooms. Seemoto delivers the validated data integrity and real-time deviation management required for GMP-regulated manufacturing.

معيار EN12830

Rely on certified accuracy. All Seemoto TS and THS sensors are EN12830 Class 1 certified, ensuring precision for the entire cold chain from -196°C to +150°C.

سلامة الأغذية HACCP

Automate your food safety plan. Replace manual clipboard checks with wireless monitoring to control Critical Control Points (CCPs). Instant hazard alerts prevent spoilage.

هيئة الغذاء والدواء الأمريكية 21 CFR الجزء 11

Secure your digital records. Seemoto provides role-based access, electronic signatures, and unalterable, time-stamped audit trails for full FDA compliance.

Data integrity and security

Security

سلامة وأمن البيانات دون أي تنازلات

End-to-End Encryption

يتم تشفير البيانات من المستشعر إلى البوابة وطوال عملية النقل إلى السحابة، مما يمنع اعتراضها أو التلاعب بها.

Role-Based Access Control

تضمن أذونات المستخدم التفصيلية أن الموظفين المصرح لهم فقط هم من يمكنهم عرض البيانات أو تأكيد الإنذارات أو تعديل الإعدادات.

Immutable Audit Trails

Every system event including logins, alarm handling, and configuration changes is permanently logged and time-stamped.

Secure Cloud Retention

تلبية متطلبات الاحتفاظ طويل الأجل للبيانات وفقًا للوائح إدارة الغذاء والدواء الأمريكية (FDA) والاتحاد الأوروبي من خلال أرشفة البيانات تلقائيًا لمدة 5 سنوات.

موارد

موارد دعم الشركاء والتحقق من صحتهم

Compliance is a team effort. Seemoto empowers our partners and customers with ready-made validation toolkits and comprehensive training.

  • Access our Partner Portal for IQ/OQ templates, user manuals, and calibration certificates
  • Rely on our dedicated support team for technical and regulatory guidance during audits
زيارة بوابة المدربين
Partner support

الأسئلة الشائعة

Ready to Simplify Compliance?

Contact our team to learn how Seemoto can help you meet regulatory requirements with confidence.