Computer Systems Validation Strategy
In a highly regulated industry, a Computer System Validation strategy is an essential part of your business.
Overview: Creating a Computer System Validation Strategy
Are you working in a highly regulated environment that requires your company to demonstrate that your infrastructure, computer systems and software do exactly what they are designed to do, in a consistent and accurate manner? Computer System Validation (CSV) helps you to ensure the consistency, quality and accuracy of your infrastructure, computer systems and software.
Why your business needs a Computer System Validation Strategy
Being able to stand over the performance of your systems and software can be challenging unless you have put in place a clear strategy to support your CSV activity and meet your regulatory compliance obligations. Having a CSV strategy simply means knowing what you want to achieve and putting a plan in place to get you there.
Find the right fit technology
The Orise Regulatory & Quality Framework provides your organisation with the guidance and tools it needs to build and execute a plan of action to achieve your computer system validation objectives. Our expertise will help you to develop a strategy that addresses regulations such as FDA 21 CFR Part 11, EMA Annex 11 and GAMP (GxP for applications).
The Orise Regulatory & Quality Framework will:
Define CSV Goals & Objectives
Work with Orise to establish clarity around your CSV goals and their purpose. We will help you identify the enablers required to achieve your objectives, so that your organization can realize the benefits of your strategy as early as possible.
Assess Situation, Identify Opportunities
It is important to know where you are starting from so you can take the next step. Orise will assess your existing CSV practices so that a baseline can be established. We will evaluate your GxP systems, identify potential risks and exposures and suggest opportunities for remediation.
Design CSV Roadmap
Orise will design a road map of activities with defined milestones and objectives that will support your CSV goals. We develop a practical plan of action that breaks down duties and tasks so that all members of the team know what they must plan for and do.
Transform Organization’s CSV Experience
Orise will support you in the execution and verification of your CSV strategy. We have a number of touch points for transformational engagement, including guidance and advice, process development, best practises implementation, test and verification, digital tool implementation and audit preparation.
Sustain CSV Activity
Orise will support you in maintaining your level of compliance, assisting you with periodic reviews, deviation management, change control and audit preparation, and making sure you have a CSV strategy that has the capacity to evolve as your organization grows.