Computer System Validation
In common usage, validation is the process of checking if something satisfies a certain criterion. Examples would include checking if a statement is true (validity), if an appliance works as intended, if a computer system is secure, or if computer data are compliant with a standard. Validation implies that one is able to document that a solution or process is correct or is suited for its intended use.
Omnia Quae is able to support you with the planning, management and implementation of your validation project. With a huge amount of hands-on knowledge and experience, Omnia Quae is able to help your business complete its validation requirements, whether you simply require assistance with provision of validation documentation, execution of validation deliverables or management of your entire validation project. Examples of some of the services we are able to offer are:
Support of life cycle activities
Vendor assessment, audit and monitoring
Assessment of vendor supplied validation packages
Provision of computer systems validation policies and procedures
Risk assessment
Software validation and SDLC documentation
Validation testing – IQ/OQ/PQ definition and execution
Maintenance of system validation
21 CFR Part 11 analyses
Computer system validation needs to be addressed throughout the whole system development life cycle from initiation through to development, testing, training, deployment and decommissioning.
Omnia Quae personnel are able to assist you because they have detailed knowledge of the Healthcare sector, and in-depth understanding of the regulatory requirements.
We assist our clients by:
Providing validation documentation required by regulatory authorities
Ensuring
validation projects are implemented on time and within budget
Reducing risk by
ensuring there is documented evidence that
the computerized system is suitable for purpose and operates properly
If you would like to find out more about Omnia Quae Validation Services then please email info@omniaquae.com