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COMMISSIONING, QUALIFICATION
AND VALIDATION

Even the best-planned projects could fail if the quality of materials and equipment do not adhere to the design, especially when they are not able to deliver the performance that is required by local and regional regulations. Situations like this could result in significant losses financially, time and more drastically consumer confidence.

Coalesce Management Consulting Offers the Commissioning, Qualification and Validation solutions to the Technology, High Tech Manufacturing, Life Sciences and Energy sectors.

 

Software testing and Validation

We provide high-quality software testing and verification engineers who ensure that all software put in place adheres to predetermined specifications and are bug-free.

 

Equipment, Facilities and Utilities Validation

We provide high-quality qualification and validation services in:
Pharmaceutical
Biotech
Medical devices
Diagnostics
Consumer products
Cosmetics
R&D Labs
Veterinary industries

The scale varies from the qualification of a single instrument or piece of equipment to a complete turnkey project. We are regularly engaged in the validation of:
Start-up facilities
Facility expansion
Facility system upgrade
Annual requalification

 

Process Validation

Process Validation combines the actual validated facility, utilities, equipment, and trained personnel with the industrial manufacturing process, control procedures, and components to produce commercial batches.

Successful process validation confirms the process design and demonstrates that future commercial manufacturing process performs as expected.

Process Validation will typically have a higher level of sampling, additional testing, and greater scrutiny of process performance than would be typical of routine commercial production. The level of monitoring and testing should be enough to confirm uniform product quality throughout the batch.

 

Cleaning Validation

The objective of cleaning validation is to provide documented evidence that a specific cleaning process will consistently clean to predetermined limits, to prevent contamination that could adversely affect the safety, efficacy, purity and quality of the products. Therefore, the implementation and validation of cleaning procedures are essential.

 

Analytical Method Validation

There has been increased regulatory scrutiny on validation of analytical methods. CMC can assist you in the validation of analytical methods to meet ICH standards. We can also support you in the validation of test methods required for your stability studies and cleaning validation studies.

Our experts will help you to identify the relevant validation requirements. We have the technical resources that will fit your needs at CMC.

Our goal is to ensure that your projects achieved their desired outcome.



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