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Computer System Validation Services

Outsource Computer System Validation Services

Effectively reduce your compliance issues and product recall risk by outsourcing computer system validation services to O2I. Prices start at $15/hour

Want to smoothen out your computer system validation (CSV) process and keep your systems legally compliant? Want to make sure your products are fit for consumers?

Outsource CSV services to Outsource2india and make sure your GxP systems operate at peak quality and efficiency. As a leading computer system validation service provider, we employ a rigorous, risk-based process to ensure the accuracy, reliability, and consistent performance of your GxP computerized systems. Our dedicated experts develop and implement various system validation strategies and processes to ensure your software and systems are regulatory-compliant and meet the quality requirements set by regulatory bodies, while minimizing the risk and legal costs.

Our Computer System Validation Services

As an experienced computer system validation service providing company, we offer end-to-end services suite to help you deal with all aspects of system validation and execution.

Our services include -

  1. Analysis and System Remediation

    Analysis and System Remediation

    We carefully analyze your systems and make sure they meet the latest US FDA guidelines for 100% regulatory compliance. While doing so, we also highlight and remediate issues that might lead to compliance issues.

  2. Process Consulting

    Process Consulting

    We offer end-to-end CSV consultation services to optimize and harmonize your CSV processes. We make sure your systems are regulatory compliant and adhere to all the standard operating procedures (SOPs). Our experts also develop templates, checklists, and training modules to train your staff, ensure your GxP systems operate with peak quality and efficiency, and to reduce your CSV timelines.

  3. Risk-Based Validation and Planning

    Risk-Based Validation and Planning

    Our experts perform comprehensive risk assessment to identify risks associated with the use of a GxP computerized system. They also work with you to create a successful validation plan that helps you to identify key elements within your system that pose high regulatory risk to your organization.

  4. Validation Test Execution

    Validation Test Execution

    We also provide a comprehensive range of well-developed and perfectly executed validation test scripts. Our validation scripts can help your testing team test the applications and computerized systems used for clinical data management, electronic data capture, electronic document management, electronic common technical documents, pharmacovigilance and more.

Our CSV Process

The major tasks performed during our validation process include -

 

01. Evaluating Your Validation Master Plan

We carefully check your existing validation plan to ensure its complete and follows industry's best regulations and practices. Our experts can also help you establish a validation strategy and highlight and remediate constraints, if any

 

02. Defining an Appropriate Validation Technique

Depending on your project and systems, we define a validation technique - inspection, simulation, analysis, review, or testing, etc., that can help you expertly validate your system as per industry regulations

 

03. Performing Validation Actions

Our experts carry out the defined validation procedures at the right time, in the right environment, using the right tools and techniques and analyze the obtained results

 

04. Ascertaining the Limits and Mitigating Challenges

Our experts define clear limits for your results and make sure your validation results are well within the limits

Other Services You Can Benefit From

Why Outsource Computer System Validation Services to Outsource2india?

Outsourcing CSV services can help you enjoy the following benefits -

  • Comprehensive Knowledge

    We have extensive knowledge of life sciences software and systems.

  • Integrated, Agile Solutions

    We offer agile solutions that are geared for continuous process improvement.

  • Customized Services

    All our solutions and services can be adapted and tailored to your specific organization's needs and help you reap the maximum benefits.

  • Fast Turnaround Time

    Our global delivery centers help us quickly and efficiently deliver all our projects, well within the promised time frame.

  • Complete Data Security

    Our data protection norms are strict and stringent.

Customer Success Stories

O2I Provided Intuitive and Robust Data Security Services to an Industrial Automation Firm

O2I Provided Intuitive and Robust Data Security Services to an Industrial Automation Firm

We employed advanced digital forensics technology and techniques to eliminate any chances of data theft for an international provider of industrial automation solutions. Our services enhanced the data security of the IT infrastructure.

Read more
O2I Provided Secure and Reliable IT Helpdesk Services to an England-based Insurance Firm

O2I Provided Secure and Reliable IT Helpdesk Services to an England-based Insurance Firm

A UK-based insurance provider required bespoke and secure IT helpdesk services to minimize downtimes, increase efficiency, and cut costs. We provided solutions that enhanced the client's efficiency and productivity.

Read more

Testimonials

They have been able to learn our procedures quicker than I ever thought possible.

General Partner, Manufacturing company in the US More Testimonials »

Outsource CSV Services to Outsource2india

Maximize the potential of your business by outsourcing CSV services to us. We can help you validate your computer programs, making sure they meet the applicable regulatory compliance and customer requirements.

Contact us to know more.

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