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