CAPABILITIES

VALIDATION

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
  • URS’s, FRS’s, DDS’s; or a comprehensive DS (Design Specification)
  • Descriptions of Operation including Normal, Challenge, Recovery, and Alarm Operations
  • SOP’s
  • Traceability Matrix
  • IQ, OQ, 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.

VALIDATION

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
  • URS’s, FRS’s, DDS’s; or a comprehensive DS (Design Specification)
  • Descriptions of Operation including Normal, Challenge, Recovery, and Alarm Operations
  • SOP’s
  • Traceability Matrix
  • IQ, OQ, 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.

LEARN MORE ABOUT OUR APPROACH TO VALIDATION

500 N BROADWAY SUITE 1600 ST LOUIS, MO 63102

(314) 621-2921

500 N BROADWAY
SUITE 1600
ST LOUIS, MO 63102

(314) 621-2921