All industries employ computer systems and software that impact the quality of products and services that they supply. Commercial imperatives dictate that organisations should verify the capability and risks of the systems they use. In some industries, standards and regulations insist that this verification must be done formally and in a way that is auditable.
From large-scale process control through to simple embedded code in a regulated device, pharmaceutical and medical device manufacturers are required to validate GxP-critical systems. Other industries have similar imperatives.
With over 20 years' experience in the design, build, implementation and validation of software for major multinational organisations; Qualsys is ideally positioned to provide Validation Support Services to customers to ensure that the software that we supply is truly meeting their needs.
Qualsys uses GAMP® guidelines and industry best practices when providing Validation Support Services.
Validated computer systems must be actively managed and maintained. Periodic reviews of configurations, operating issues, change control processes and comparisons with the evolving best practices are all essential to ensure continual compliance.
Qualsys provides an proactive integrated service to ensure that your computer system validation process adds value and reduces business and regulatory risk.
The Validation Process
We assist our customers with their validation process through the provision of consultancy, information and assistance.
We ensure that validation process progresses smoothly and quickly by providing template documentation drawn from previous experience and by lessening the impact of the most time and resource-consuming tasks by providing advice and assistance. The service can include the following components:
· System Specification– Definition of system functional requirements to meet user operational needs and regulatory requirements.
· Validation Planning– Defining the process by which validation will be achieved, including inputs and related information required, activities to be undertaken, resources required and evidence to be produced.
· Risk Management– Comprehensive consideration of potential factors which could impact on success and identification of the controls in place to mitigate their impacts.
· Supplier Selection– Co-operation with supplier evaluation and audit, including provision of evidence of certified software development.
· Installation Qualification – We perform and document a standard series of test to verify that the system is correctly installed and performing as expected.
· System Configuration– We provide implementation consultancy and training to assist you to implement EQMS in a way that meets the specified requirements.
· Operational / Performance Qualification - Assistance in acceptance test planning and testing to validate that the configured system meets the functional needs of the organisation.
· System Change Control - We advise on, agree and implement suitable change control procedures to ensure that system updates do not adversely impact on system performance.
· Problem Resolution Process and Tracking– We log and monitor all your support calls as part of our Support and Maintenance service. Reports from this are available to you on a periodic basis as evidence of problem resolution performance.