Only Validation Documentation Can Protect Your Data!

The purpose of computer system validation (CSV) is to guarantee confidence in the data captured, processed, reported or stored on computerised systems. A validated system ensures accurate results and reduces any risks to data integrity.

The extent of validation activities should be defined based on a risk assessment, considering the dependency of the accuracy and traceability of data on the computerised system. Due to the great variety of computerised systems available, it is not possible to state in a single document, all the specific validation elements that are applicable. A validation matrix should be developed from the risks and mitigations identified from the risk assessment for each system evaluated.

The approach to CSV can be described within your site wide Validation Master Plan (VMP) and it should list the documents below, that should be available, depending on the type of system being validated.

✔Inventory list, Name, version and unique identification of the computerised system

✔Original files (CD-ROM…) or storage location to install the computerised system, and computerised system to manage the computer environment

✔Date at which the computerised system was put into operation

✔Responsible person in charge of the computerised system

✔Manufacturer’s name, licence number and serial number or other unique identification, where applicable

✔Conditions under which the computerised system runs, where applicable (hardware, operating system, …)

✔Manufacturer’s validation certificate, if available

✔Manufacturer’s instructions, if available, or reference to their location

✔Documentation on validation of configurations/modifications performed by the user that can impact the results

✔Name of the person who developed and validated the computerised system, and the date of validation

✔Source code (if available)

✔Operating instruction (SOP)

✔Documentation on computerised system periodic review and results of audits

✔Documentation on computerised system validation

✔Follow-up of failures encountered, maintenance of the process, changes, updated versions and , where appropriate, configuration management

✔Training records (depending on the complexity of the system)

✔Records of the regular testing of backup data (restore test).

If you would like to explore how we can support CSV implementation for your business, please book a free call with us through the below link.