Tested to perfection
Streamline and simplify your validation process when deploying IDBS software into GxP and 21 CFR Part 11 regulated environments.
Our Validation Services are delivered by experienced consultants who collaborate with your teams to coordinate testing of your IDBS deployment.
Years of experience, unparalleled knowledge
In addition, these consultants help prepare documentation that supports your internal validation process and compliance of configured software.
They also offer in-depth knowledge of the laboratory environment combined with many years’ experience working with information technology. You also benefit from their knowledge of the latest developments in regulatory compliance and associated services.
- Knowledge of the laboratory including equipment, techniques, processes and methods
- Understanding of information technology including software and applications, integrations, networking, operating systems and information security
- Many years’ experience of regulatory compliance and associated services including GxP, 21 CFR Part 11 and SAFE needs
Validation Services offered by IDBS can provide transformational benefits to our customers’ internal computer system validation process. By offering supplier Installation Qualification (IQ) and Operational Qualification (OQ) documentation and associated services, IDBS reduces the internal cost and significantly accelerates the time to validate.
IDBS Validation Services form an integral part of the customer validation master plan and provide the level of detail and quality to ensure this can be done with minimal changes. IDBS Validation Services and documentation are updated each time we carry out a project as a part of a continuous improvement process. This means we have a repeatable and low risk approach to validation and consultants who have the experience to execute this work efficiently.
For each IDBS software release the IQ & OQ documentation is updated and executed by IDBS to generate an internal IDBS pre-qualification report. We also generate a risk analysis for each software version to assist customers to assess the impact of upgrading on their business. This means that we can always provide our customers with the most up to date IQ & OQ documentation, and so reduce delays and customer costs by carrying out much of the work that would typically need to be performed by the customer prior to upgrade.
Validation Services add confidence to a customer that IDBS software can be deployed into regulated environments such as GxP and 21 CFR Part 11, with the minimum of effort and risk to the project.