Certifications & Compliance

Sol.i.Pharma certifications ensure quality, safety, and full regulatory compliance in the pharmaceutical and medical sector. Each system is developed according to international standards and validated to operate in controlled environments.

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Sol.i.Pharma certifications ensure quality, safety, and full regulatory compliance in the pharmaceutical and medical sector. Each system is developed according to international standards and validated to operate in controlled environments.

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ISO 9001:2015 certification for quality management systems
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CE compliance with European directives (Machinery 2006/42/EC, EMC 2014/30/EU)
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Certified cleanroom compatibility up to ISO Class 5
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Automatic verification and control of processes according to strict regulatory standards
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Certified quality and operational compliance

Our systems are designed to ensure operational safety, regulatory compliance, and consistent performance in highly regulated pharmaceutical and medical environments.

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Systems certified according to international ISO standards
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Reduction of operational risks through validated systems
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CE compliance with European regulations
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Continuous quality control throughout the entire lifecycle
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Certified compatibility for cleanroom environments up to ISO Class 5
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Verified operational reliability through certified testing
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Automation of chemotherapy preparation in a hospital pharmacy CPA

Certification and quality control process

Each system is developed and verified through a structured process that ensures regulatory compliance, consistent quality, and operational safety.

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01.

Regulatory requirements analysis

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We assess applicable regulations and technical requirements to ensure compliance from the design stage.
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02.

Validation and quality control

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Each system is tested according to ISO standards and certified protocols.
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03.

Certification and continuous monitoring

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Systems are certified and continuously monitored to maintain performance and compliance over time.
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Our certifications and regulatory compliance are supported by international standards and qualified technology partnerships, ensuring recognized reliability in the industry.

Compliance with European regulations

Our systems comply with key CE directives, ensuring safety, reliability, and compliant use in controlled environments.

ISO Certifications

ISO 9001 certified processes ensure consistent quality, operational control, and continuous improvement.

Cleanroom Validation

Certified compatibility for controlled environments according to ISO standards, with testing on particulate emissions and operational safety.

Traceability and safety

Systems designed to ensure full traceability of operations and reduce the risk of human error.

Certified partners

We collaborate with certified technology partners to ensure quality in distribution, installation, and support.

International standards

Each solution is developed in line with global regulations for the pharmaceutical and medical sectors.

Frequently asked questions about certification and compliance

1.

What certifications does Sol.i.Pharma have?

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Sol.i.Pharma is certified according to ISO 9001 standards for quality management. Additionally, its systems comply with applicable European CE directives and are tested for use in controlled environments.

2.

What does CE compliance mean for your systems?

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CE compliance indicates that the systems meet European regulations regarding safety, performance, and reliability. This includes directives such as the Machinery Directive and electromagnetic compatibility.

3.

Are your systems suitable for cleanroom environments?

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Yes, the systems are tested for controlled environments and are compatible up to specific ISO classes, ensuring safety and control of particulate emissions.

4.

How do you ensure the quality of your processes?

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Through ISO 9001 certified systems, we adopt structured processes for quality control, continuous improvement, and operational traceability.

5.

Are certifications updated over time?

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Yes, certifications are maintained and periodically renewed to ensure compliance with updated regulations and industry standards.

6.

Is it possible to download official certificates?

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Yes, certificates and declarations of conformity are available for download directly in the dedicated section of the page.

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