VISTX provides transformation, cloud compliance as well as infrastructure qualification and strategy services tailored specifically for life sciences organizations. Our team of seasoned professionals take a holistic approach – operations, technical and compliance – to help drive organizational change and deliver unsurpassed results.
The life sciences industry has become increasingly dependent on computer systems to run its business. With the increasing reliance on the Cloud models collectively known as XaaS)
iMaintaining control over our infrastructure and applications is essential. In fact, regulatory agencies are, in some cases, requiring that Infrastructure be qualified.
IT Infrastructure should be brought into initial conformance with the regulated company’s established standards. This can be achieved through a planned qualification (specification and verification) process, building upon recognized industry good IT practices. Once in conformance, this state should be maintained by documented standard processes/procedures and quality assurance activities
Qualification is meant to provide evidence that the infrastructure:
Bottom line: You need to Qualify your infrastructure regardless of where the services are located. That said, it is important that we utilize a process that is efficient while meeting the objectives of qualification.
Our proven approach was designed to ensure that the process is efficient and cost-effective while maintaining compliance with regulations, guidance and industry best practices throughout the lifecycle.
During the Discovery Phase, we review current procedures, discuss future objective and review requirements for Infrastructure Qualification.
Our Strategy Phase outlines the activities to Qualify the Infrastructure and ensure that the environment remains under control.
Our Governance Phase outlines the requirements for compliance. SOP’s, Work Instructions, Forms, etc.
Our Discovery activities determine the best path to drive maximum results. As part of the process, we partner with you to help determine your objectives, culture and capabilities Key activities include:
Taking the input from the Discovery Phase, VISTX partners closely with you to develop a Plan and Roadmap for deploying your new Infrastructure Qualification Model
How will we qualify our infrastructure? What controls need to be in place? What are the governing SOPs? Are there any tools that can help automate the process?
VISTX helps complete the assessment, asking the right questions and make sure
Key activities include:
The Plan should be based on your culture, risks, capabilities and resources along with industry best practices.
This phase prepares the organization for your Infrastructure Qualification program. It should include:
VISTX has extensive experience helping our clients implement new processes and update existing processes to maximize value and minimize risk.
This model must includes assurance that all processes and procedures are in place, to control tp maintain control throughout.
This first step in the Qualification Process is to create your Qualification Plan. The Qualification Plan should include:
The next step is to do a Risk Assessment.
Note: In some circumstances, you might include this as part of your Infrastructure Qualification procedure.
The specification and design is what we use as the baseline for “built as intended.”
Our typical approach is to create a request form that can serve as the specification.
The Design is usually documented by an Architecture Diagram.
Using any available automation, build the infrastructure as soecufued un the. Request Form.
Automated tools allow you to rely on the Vendor Assessment and previous testing to reduce the overall effort of the testing process as well as minimize the risk.
Execute your Qualification Form or Protocol and gather the evidence.
Submit the package for Quality approval.