Member Since 1982



​Gene Zamba Consulting Services 

​​ 

  • Home
  • About
  • FDA, CE and Regulatory
  • Engineering and Prototyping
  • Electrical Engineering
  • Computer Systems Validation
  • Products
  • ISO 13485-2016 Audits and QMS
  • Contact
  • Home
  • About
  • FDA, CE and Regulatory
  • Engineering and Prototyping
  • Electrical Engineering
  • Computer Systems Validation
  • Products
  • ISO 13485-2016 Audits and QMS
  • Contact

Computer System Validation (CSV) is mandatory for industries required to meet FDA regulatory compliance.


We deliver highly successful and cost-effective CSV. 


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


We also, provide 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


  • Home
  • About
  • FDA, CE and Regulatory
  • Engineering and Prototyping
  • Electrical Engineering
  • Computer Systems Validation
  • Products
  • ISO 13485-2016 Audits and QMS
  • Contact


/
Lightbox image