Validation

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If you operate in a regulated industry, such as pharmaceuticals or food and beverage production, we ensure that every aspect of your system is fully compliant with all regulations. We minimize your risk through every stage of our work and use a proven validation process to meet all validation requirements.

Computer System Validation (CSV) is mandatory for industries required to meet FDA regulatory compliance for manufacturing. Comprehensive CSV requires detailed and complete documentation of the manufacturing automation system; from the field devices, networks, controllers, graphic displays through to the data archiving and reporting platforms. Information integrity and security are absolutes in an automation system meeting FDA compliance. Additionally topics such as SOP’s, technical training, periodic reviews, document retention and Change Control procedures must be addressed.

Malisko delivers highly successful and cost effective CSV. We follow GAMP5. Our writers, subject matter experts and testers all have extensive automation system experience. Malisko knows how to seamlessly combine system documents with validation documents so both are complimentary. Malisko can provide comprehensive CSV documentation and execution, or collaborate with a Client’s Compliance Group to provide support as needed. Either way, Malisko’s CSV deliverables meet FDA regulatory compliance and pass audits.

Malisko has experience with designing, implementing, deploying and validating electronic records and signatures – Title 21 CFR Part 11 – for manufacturing automation.

Malisko provides services for both CSV and automation system integration; including and not limited to:

    • Validation Master Plans
    • Test Plans
    • User Requirement Specifications (URS)
    • Functional Requirement Specifications (FRS)
    • Drawing Data Sheet (DDS)
    • Comprehensive Design Specification (DS)
    • Descriptions of Operation including Normal, Challenge, Recovery, and Alarm Operations
    • Standard Operating Procedures (SOPs)
    • Traceability Matrix
    • Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
    • Deviation Reports during Qualification Execution
    • Test Reports
    • Validation Summary Reports

Malisko Engineering helps Clients in the FDA regulated industries with CSV that is complete, detailed and meets the stringent demand of auditors.

Computer System Validation (CSV) is a must in FDA regulated industries. We design and implement your system to deliver consistent, efficient production that also meets CSV for FDA. And we prove it too. If you operate in a regulated industry, we take care of the paperwork related to CSV and reduce your Regulatory risk. We can provide a Validation Master Plan (VMP) and use it to guide our work. We document requirement specs, design specs, functional specs, test plans, installation and operational protocols, trace matrices, and summary reports. We execute the protocols as well. We assist with keeping your records up-to-date via change control and help keep your system in compliance. Minimizing risk is ingrained in our company because we are committed to delivering you ROI.

During this phase we can provide you with:

Click the links above to learn more about each one.

If you operate in a regulated industry, such as pharmaceuticals or food and beverage production, we ensure that every aspect of your system is fully compliant with all regulations. We minimize your risk through every stage of our work and use a proven validation process to meet all validation requirements.

Computer System Validation (CSV) is mandatory for industries required to meet FDA regulatory compliance for manufacturing. Comprehensive CSV requires detailed and complete documentation of the manufacturing automation system; from the field devices, networks, controllers, graphic displays through to the data archiving and reporting platforms. Information integrity and security are absolutes in an automation system meeting FDA compliance. Additionally topics such as SOP’s, technical training, periodic reviews, document retention and Change Control procedures must be addressed.

Malisko delivers highly successful and cost effective CSV. We follow GAMP5. Our writers, subject matter experts and testers all have extensive automation system experience. Malisko knows how to seamlessly combine system documents with validation documents so both are complimentary. Malisko can provide comprehensive CSV documentation and execution, or collaborate with a Client’s Compliance Group to provide support as needed. Either way, Malisko’s CSV deliverables meet FDA regulatory compliance and pass audits.

Malisko has experience with designing, implementing, deploying and validating electronic records and signatures – Title 21 CFR Part 11 – for manufacturing automation.

Malisko provides services for both CSV and automation system integration; including and not limited to:

    • Validation Master Plans
    • Test Plans
    • User Requirement Specifications (URS)
    • Functional Requirement Specifications (FRS)
    • Drawing Data Sheet (DDS)
    • Comprehensive Design Specification (DS)
    • Descriptions of Operation including Normal, Challenge, Recovery, and Alarm Operations
    • Standard Operating Procedures (SOPs)
    • Traceability Matrix
    • Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
    • Deviation Reports during Qualification Execution
    • Test Reports
    • Validation Summary Reports

Malisko Engineering helps Clients in the FDA regulated industries with CSV that is complete, detailed and meets the stringent demand of auditors.

Computer System Validation (CSV) is a must in FDA regulated industries. We design and implement your system to deliver consistent, efficient production that also meets CSV for FDA. And we prove it too. If you operate in a regulated industry, we take care of the paperwork related to CSV and reduce your Regulatory risk. We can provide a Validation Master Plan (VMP) and use it to guide our work. We document requirement specs, design specs, functional specs, test plans, installation and operational protocols, trace matrices, and summary reports. We execute the protocols as well. We assist with keeping your records up-to-date via change control and help keep your system in compliance. Minimizing risk is ingrained in our company because we are committed to delivering you ROI.

During this phase we can provide you with:

Click the links above to learn more about each one.

Case Study: Pharmaceutical Company Begins Manufacturing New Generic Therapeutic Drug with The Help Of Advanced Process Automation System

A pharmaceutical manufacturer needed to finalize production of a new generic therapeutic drug. As part of their initiative, they wanted to include a state-of-the-art, robust, expandable, and supportable automation system to control, data archive and report on their world-class process.

Case Study: Infant Formula Manufacturer Enhances Its Ability to Capture and Retain Secure Historical Data

A historian collecting manufacturing data on highly critical infant formula is extremely vital for the safe and healthy future of our most prized possessions: babies.

Case Study: Emergency Callout Service (ECS) at Christmas Time Quickly Resolves Problems in Plant’s Critical Operations

A client contacted Malisko to assist with getting a critical system back up and running; a system that Malisko had nothing to do with.

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