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Commissioning, Qualification and Validation (CQV)

Protect the integrity of your critical products with precise CQV Solutions

When a life sciences company manufactures a product or a material, it must follow cGMP guidelines to ensure the integrity and quality of the item. Whether you have a small batch of plasmids in a chamber or drums of an API (active pharmaceutical ingredient) in a freezer,  you want to ensure the storage unit is fit for purpose—qualification. You also want to ensure it will continue operating within the parameters proven to consistently and reliably deliver the desired outcome—validation. Qualifying and validating your storage chambers ensures your items and materials are maintained at their intended condition throughout storage.

Alcami's Validation department is the gold standard in CQV. We provide our customers with documented evidence that their equipment and instrumentation are installed correctly, operating accurately, and performing reliably per predetermined user requirements.

Comprehensive IQ/OQ/PQ Validation Solutions

Controlled Chamber and Storage Area Qualification

Refrigerators, freezers, stability chambers, and warehouses provide crucial protection to your materials, products and devices. Validating your controlled temperature units with Alcami gives you confidence in the integrity and efficacy of the products you administer to your patients.

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Autoclaves & Sterilizers

Maintain the safety and efficacy of your products by validating your autoclaves and sterilizers to the highest standards. Alcami utilizes industry-leading validation practices to execute installation, operational, and performance qualifications for your sterilization equipment.

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Steam-in-Place

Confirm the successful application of steaming procedures and ensure sterility with Alcami’s steam-in-place validation practices. We help you prevent cross-contamination and deliver safe and effective products to your patients.

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Manufacturing & Lab Equipment/Computer Systems

Alcami can support your company with onboarding of all GxP system types. Alcami can develop and execute the following deliverables: 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 and SOPs.

Facilities & Utilities

Alcami can support your facility commissioning and qualification needs for existing or new GxP areas, including the following and more: HVAC, BAS, EMS and Utilities (Electrical, Water, Steam, Process Air, Vacuum, CO2, N2).

Industries We Serve

  • pharmaceutical

    Pharmaceutical

  • biotechnology

    Biotechnology

  • lifesciences

    Life Sciences

  • medicaldevice

    Medical Device

Providing Intelligent Solutions in CQV

At Alcami, we specialize in executing large-scale validation projects efficiently. We also have the tools and expertise to execute a project of any size.  Alcami has executed tens of thousands of qualifications ranging from environmental chambers to laboratory and manufacturing equipment and enterprise systems under tight timelines meeting our customer's timetables and schedules.

The combination of our equipment, ISO processes, and expert, talented teams have made us self-sufficient and has us leading the industry. As a result, you can count on us to handle any project with the highest quality level. 

Alcami can support your company with onboarding of all GxP system types. We can develop and execute the following deliverables:

  • 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

Advantages of Working with Alcami Validation

  • We own all our equipment--a seemingly endless supply of validation equipment and access to hundreds of data acquisition systems and wireless dataloggers. Many of our competitors turn to us to rent equipment for their validation projects.
  • We fabricate, harness and label our own thermocouples. Our competition knows where to get the best products.
  • Our equipment is calibrated and maintained by our NVLAP Accredited, ISO 17025:2017 calibration lab, ensuring the highest standards and processes (NVLAP lab code 200904-0)
  • Alcami is ISO 9001:2015 certified to ensure our commitment to quality services.

The Alcami Difference

For decades, we have been proudly referred to as the experts in CQV. Our validation team consists of specialized engineers who have undergone extensive mentorship and apprenticeship. They are experienced in project management and provide subject matter expertise. Our team has executed projects throughout the country and the globe, contributing to their diverse experience.

We also perform the services for CQV that we provide our customers internally for our laboratory, manufacturing and warehouse operations. Our external practices are based on our internal procedures that have been reviewed heavily by the regulatory bodies and during customer audits.

The validation department excels in taking on large temperature mapping projects under tight deadlines using our equipment efficiently. We have countless examples, including our “Gold Standard” project, where we set the bar by executing 168 chamber qualifications in 6 weeks with four validation engineers. The defining highlight of this project was completing it well ahead of the customer’s schedule.

Our validation engineers report study results with accuracy and transparency while demonstrating our dedication to quality. From project start to completion, they are committed to showing that our equipment is accurate and that our services can be trusted. 

When you use our CQV services, you partner with a transparent and trustworthy company. Integrity is at the core of who we are. Quality is not just a department – it’s ingrained in our history and future. We will continue to honor these principles, and we remain steadfastly committed to intelligent solutions in validation and qualification.

Self-sufficiency is just one way that we set ourselves apart from others. We also have industry-leading processes and experts that go above and beyond. Our talented team of nimble, tactful, trained engineers use best practices steps to complete validation projects. These engineers know that auditors and regulatory agencies rely on the validation documentation to ensure cGMP compliance is met.

Before we arrive on-site to start a validation project, we strategically plan out your project. Before releasing completed validation reports to our customer, we follow documented guidelines that outline reviewing report information and completing the approval process.