Computer System Validation

Audree Infotech is a home to highly-trained and experienced computerized systems validation consultants.

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Why Computer System Validation?

It is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality. The same principles should apply in computer system validation to a computer system or an information technology system. Computer system validation checks the effectiveness and the efficiency of product and meeting the requirement for which it designed.

Processes Needed for Computer System Validation

CSV is dependent on the complexity of the project and can be largely broken down into the following modules.

Master Plan

It checks whether the specifications are in line with user requirements and teams are also established which will run the entire process. The set of activities need to be carry during validation will established and this is the process of preparing the blueprint for the entire CSV. This process is the pivot of a validation program since it covers the complete setup.

Project Plan

It defines the standard operating procedures for each process in a validation assessment program and is a subset of the master validation plan. Mainly, it defines a deadline within which the CSV must complete. A detailed documentation and training on the standard operating procedures (SOPs) carried out in this process.

Installation Qualification (IQ)

IQ delves deeper into the installation process, creates checks, and balances for any new component that may have been require or any new software or hardware that might have installed.

Operational Qualification (OQ)

OQ checks the accuracy of the operational functions and the security process such as physical security, software security, firewalls etc.

Performance/Process Qualification (PQ)

PQ tests specific applications and proactively engages in maintenance and conducts performance tests.

Computer System Validation expert have validated computer programs including pharmaceutical and biologics manufacturers and clinical research organizations.

Software Validation

Computer systems validation services for SAP, LIMS, Salesforce, and data management system.

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