PLC Validation

PLC Validation

The purpose of the validation process is to provide a high degree of assurance that a specific process (or in this case computer system) will consistently produce a product (control information or data) which meets predetermined specifications and quality attributes.

The objective of computer system validation is to produce documented evidence, which provides a high degree of assurance that all parts of the facility will consistently work correctly when brought into use. Computer systems validation includes validation of both new and existing computer system.

Why PLC Validation is needed ?

• Reduce risk and legal liability.
• Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice.
• Validation is applied to many aspects of the healthcare and other regulated industries and businesses.
• FDA regulations mandate the need to perform Computer System Validation and these regulations have the impact of law.