Commissioning Qualification & Validation

Optimizing Systems for Maximum Efficiency and Compliance
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Our CQV services ensure that your facilities, utilities, systems, equipment and processes are designed, installed and operated as intended in compliance with all applicable regulations and industry standards. We use recognized methodologies and proven standards from GAMP 5 to 21CFR11, EU Annex 11 and ISPE guidelines.
Commissioning

We ensure that systems are equipment are installed, configured, and function as intended.

We partner with you for your new facilities, lines, or expansion projects from the beginning to the end. We interface with engineers, design and construction companies and ensure optimized flows for your production train, compliant rooms classifications and adequate segregations. We review designs and drawings and ensure your future operational capability is efficient and will meet all applicable regulations.

We help you implement an all-encompassing qualification and validation programs. From establishing Validation Master Plans to writing protocols and executions. Our seasoned consultants can assist you in doing your FAT, SAT, IOPQ and design an ongoing periodic qualification schedule commensurate with your facilities and processes risks, as well as expected regulatory requirements.
No matter how simple or complex your processes are, how new or long established, we help you validate all of your manufacturing, packaging, and analytical processes and demonstrate you state of control.
Our expert cleaning validation consultants assist you in building a comprehensive Cleaving Validation Master Plan, determine your worst-case products, calculate PDE and MACO, implement and execute detailed cleaning validations. From manual cleanings to fully automated CIP and SIP systems, we develop and validate cleaning cycles, sterilization cycles, help you identify the best cleaning solutions for your needs and validate all supporting methods.

In today’s regulated industries, computer systems play a crucial role in ensuring quality of products and integrity of data. Our CSV expertise will help you ensure that your computerized systems are compliant with regulatory requirements and industry standards.


Let offer software and hardware computerized systems validations, we help you implement a fully compliant computerized systems validation master plan with all necessary risk identification and mitigation tools, software regulatory assessment forms, including the generation and execution of validation protocols. We help you implement access control strategies and procedures, and maintain full control over your hosted and cloud-based GMP-related applications.

Ensure compliance and operational excellence with Lesirg’s comprehensive CQV services. Our expert consultants guide you through every step, from commissioning to validation, delivering tailored solutions for your facility’s needs. Trust us to streamline your processes and maintain the highest industry standards, so you can focus on driving innovation with confidence.

Learn How Lesirg Can Address All of Your CQV and Computer Systems Validation Needs

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