Computer Systems Validation
At Performance Validation, we commit to provide efficient, cost-effective, timely, and high quality computer system validation which not only meets regulatory requirements, but can also add value to your business. Our CSV professionals will deliver your project with integrity and excellence demonstrated through a focus on practical implementation of compliance and rendering of model solutions - while never losing sight of your goals, scope, and priorities. Our goal is to provide you with the peace of mind with respect to the management and accomplishment of project work in which we have been entrusted to complete.
Performance Validation stays current with the latest industry standards and best practices such as Good Automated Manufacturing Practices (GAMP), TIR-36, AAMI, and FDA Guide to software validation. We have successfully developed and deployed the full suite of CSV documentation for systems ranging in complexity from spreadsheet validation to integrated platform solutions. With years of experience in mechanical, automated, and instrumentation aspects of a system, Performance Validation is poised to deliver a right-sized and integrated solution to assist you in meeting your CSV needs.
Regulatory compliance is at the forefront of Performance Validation professional’s minds in planning a computer system validation project. Knowing how to efficiently and effectively meet regulatory requirements and industry standards is one of our specialties. Performance Validation can comply with and adapt to your processes and procedures and/or implement CSV methodologies to make the project a success.
Performance Validation can manage and support your entire CSV project and/or any component of your software lifecycle.
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Performance Validation offers the following services related to Computer System Validation:
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Performance Validation has experience with the following types of Computer Systems:
Validation Project Planning
Performance Validation professionals plan CSV projects, using a Risk Based Approach, to find the most efficient, cost-effective, high-quality, method for your system to meet your business needs while achieving regulatory compliance.
This is achieved by the system's risks, software category (based on system design complexity), supplier assessments and/or audits, and other objective factors drive documented justification for focused testing and streamlined documentation requirements - controlling your project costs and minimizing timelines while not sacrificing quality and regulatory requirements.
Typical Validation Project Planning Activities / Deliverables include
(including, Expense, Project Status and Milestone management and tracking reports)
System Design and Specification
Eliciting, writing, and managing system specifications are among our many areas of expertise.
Typical System Design and Specification Activities / Deliverables Include
User Requirement Specification
• Functional Requirement Specification
Testing plays a central role in a validation project. Whether you and your stakeholders require assurance that your system is installed correctly, functions properly, and/or performs based on your intended use, Performance Validation has the right-sized approach.
Typical Software Testing Activities / Deliverables Include
Summary Reports provide internal/external auditors and stakeholders with valuable information on the validation process and status of the system.
Typical Validation Project Reporting Activities / Deliverables Include
Performance Validation can assist the client in the management and validation of new projects; we can also provide a similar service for changes, modifications, and upgrades to IT Infrastructure and/or application changes.
Typical Change Management Activities/ Deliverables Include
In addition to the normal Validation activities of Planning, Specification, Testing and Reporting – PV can assist in developing and execution of the change control including archival of the obsolete software and data archive or migration to the new application.
Performance Validation professionals have years of experience providing guidance and training on computer system validation. We can offer customized instruction on best practices and industry standards and can help you develop and implement a compliant computer system validation program.
Performance Validation has a number of ASQ Certified Quality Auditors available to assist you. Our auditors have audited a number of software vendors in support of CSV projects.
Typical Auditing Activities/ Deliverables Include
Business Information Systems
Process Automation Systems
Applications/ IT Infrastructure
Laboratory Information Systems
Laboratory Instrument CSV