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Pharma Services

Commissioning, Qualification and Validation (CQV)

Pharma Services

Comprehensive Commissioning, Qualification, and Validation for Controlled Storage Environments

In the life sciences industry, maintaining the quality and integrity of products and materials is paramount. cGMP guidelines are the cornerstone of ensuring that these standards are met throughout the entire storage process. Whether it’s a small batch of plasmids stored in a chamber or drums of an API (Active Pharmaceutical Ingredient) in a freezer, the reliability of your storage units is crucial. Alcami ensures that your equipment and instruments are qualified for their purpose, operating consistently within your required parameters to deliver reliable results.

Life sciences companies follow cGMP guidelines to make sure the quality and integrity of their product or material is maintained at their intended condition throughout storage. Whether it’s a small batch of plasmids in a chamber or drums of an API (active pharmaceutical ingredient) in a freezer, you want to know the storage unit is qualified for its purpose. You also want to ensure it will operate within your required parameters to consistently and reliably deliver the desired outcome.

Alcami’s Validation department provides the documented evidence you need — to know the equipment and instrumentation are installed correctly, operating accurately, and performing reliably.

Comprehensive IQ/OQ/PQ Validation Solutions for Complete Assurance
Controlled Chamber and Storage Area Validation Refrigerators, freezers, stability chambers, and warehouses play a critical role in safeguarding your materials and products. Alcami’s validation services for controlled temperature units ensure that your products maintain their integrity and efficacy, giving you the confidence that they will perform as intended when administered to patients.
Autoclave and Sterilizer Validation The safety and efficacy of your products depend on the rigorous validation of autoclaves and sterilizers. Alcami employs industry-leading practices to meet the installation, operational, and performance qualifications of your sterilization equipment, ensuring your products remain safe and effective.
Steam-In-Place Validation for Sterility Assurance Preventing cross-contamination and ensuring sterility is vital in the life sciences industry. Alcami’s steam-in-place validation services confirm the effectiveness of steaming procedures, helping you deliver safe and effective products to patients.
GxP System Onboarding and Equipment Validation Alcami offers comprehensive support for onboarding all GxP system types, including manufacturing and lab equipment, as well as computer systems. Our services include GxP and 21 CFR Part 11 assessments, validation plans, risk assessments, and performance qualifications. We streamline your compliance processes, enhancing operational efficiency and ensuring thorough validation tailored to regulatory requirements.
Facility and Utility Qualification for Optimal Performance Alcami provides expert support for commissioning and qualifying your GxP areas, including HVAC, BAS, EMS, and utilities such as electrical, water, steam, process air, vacuum, CO2, and N2. Our services ensure optimal performance and regulatory compliance across your critical facility systems.

Comprehensive IQ/OQ/PQ Validation Solutions for Complete Assurance

Controlled Chamber and Storage Area Validation

Refrigerators, freezers, stability chambers, and warehouses play a critical role in safeguarding your materials and products. Alcami’s validation services for controlled temperature units ensure that your products maintain their integrity and efficacy, giving you the confidence that they will perform as intended when administered to patients.

Autoclave and Sterilizer Validation

The safety and efficacy of your products depend on the rigorous validation of autoclaves and sterilizers. Alcami employs industry-leading practices to meet the installation, operational, and performance qualifications of your sterilization equipment, ensuring your products remain safe and effective.

Steam-In-Place Validation for Sterility Assurance

Preventing cross-contamination and ensuring sterility is vital in the life sciences industry. Alcami’s steam-in-place validation services confirm the effectiveness of steaming procedures, helping you deliver safe and effective products to patients.

GxP System Onboarding and Equipment Validation

Alcami offers comprehensive support for onboarding all GxP system types, including manufacturing and lab equipment, as well as computer systems. Our services include GxP and 21 CFR Part 11 assessments, validation plans, risk assessments, and performance qualifications. We streamline your compliance processes, enhancing operational efficiency and ensuring thorough validation tailored to regulatory requirements.

Facility and Utility Qualification for Optimal Performance

Alcami provides expert support for commissioning and qualifying your GxP areas, including HVAC, BAS, EMS, and utilities such as electrical, water, steam, process air, vacuum, CO2, and N2. Our services ensure optimal performance and regulatory compliance across your critical facility systems.

Industries We Serve:
Pharmaceutical
Biotechnology
Life Sciences
Medical Device

Expertise in Commissioning, Qualification, and Validation (CQV)

Large-Scale Validation Projects with Precision

Alcami excels in executing large-scale validation projects with unmatched precision and efficiency. Our extensive experience, combined with industry-leading tools and processes, makes us a trusted partner for projects of any size. With a proven track record of tens of thousands of qualifications, Alcami is equipped to handle any project, delivering the highest level of quality on time and within budget.

Unmatched Equipment and Calibration Standards

Alcami’s commitment to quality is evident in our ownership and maintenance of top-tier equipment. Our ISO 17025:2017 accredited laboratory ensures rigorous calibration standards, and our in-house fabrication of thermocouples provides superior accuracy and reliability. These advantages translate into exceptional validation services that meet the highest industry standards.

Alcami can support your company with onboarding of all GxP system types:
Assessments (GxP and 21 CFR Part 11)
Specifications (User, Design, Functional, Configuration)
Validation Plans
Risk Assessments
Installation Qualifications
Operational Qualifications
Performance Qualifications
Traceability Matrices
Final/Summary Reports
SOPs

The Alcami Difference

Excellence in Temperature Mapping and Validation

Alcami’s validation team is composed of specialized engineers with extensive mentorship and project management experience. Our team’s expertise in large-scale temperature mapping projects is unparalleled. For instance, our “Gold Standard” project, which involved 168 chamber qualifications completed in just six weeks, showcases our ability to deliver results ahead of schedule with exceptional quality.

Integrity, Trust, and Transparency in Validation

At Alcami, integrity and transparency are the foundation of our CQV services. We believe that quality is not just a department; it’s ingrained in our history and future. By partnering with us, you gain a trustworthy ally committed to delivering intelligent validation and qualification solutions.

Industry-Leading Validation Processes

Alcami’s self-sufficient approach and industry-leading processes set us apart. Our highly trained engineers utilize best practices to complete validation projects efficiently and accurately. We strategically plan every validation project, ensuring compliance with cGMP standards and regulatory requirements. Our meticulous review process guarantees the reliability and accuracy of every validation report we produce.

Partner with Alcami for Reliable Validation Services

Alcami’s commitment to quality and reliability ensures that your critical validation projects are executed with precision, offering you peace of mind and confidence in the integrity of your products and processes.

Summary

Alcami Corporation offers comprehensive Commissioning, Qualification, and Validation (CQV) services to ensure the safety and compliance of critical life sciences products. With expertise in validating storage environments, sterilization equipment, and GxP systems, Alcami delivers reliable, efficient solutions that meet regulatory standards. Our commitment to quality and transparency makes them a trusted partner across the life sciences industry.

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