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Our teams undertake validation for all computerized systems working on product quality, patient safety, and maintaining data integrity. At Flatworld, we have designed a methodology for CSV services that meet the regulatory requirements of the project as well as streamline the business operations in a way that ensures efficient implementation at speed. From planning to testing and configuration management, our CSV experts cover all aspects of validation.

Hence, the end goal of our team is to offer end-to-end validation solutions that are compliant and reduce the validation burden on your internal teams.

Computer System Validation Services We Offer

Our system validation capabilities include the following -

Regulatory Impact Assessment

Flatworld's validation experts assess your systems based on your GxP requirements and criticality, software category, and audit system scope complexity to understand the compliance of the software with these regulations. Based on this, they develop enterprise validation master plans and run supplier or vendor audits along with regulatory gap analysis and remediation.

System Specifications

Our professionals conduct an in-depth study to understand the requirements of the computerized systems for various users. Outlining user requirement specifications, functional and design specifications act as the foundation to analyze the intended use of the system that aids in further testing for validation.

Testing

At Flatworld, our expert testers develop testing protocols based on the project needs and deploy a modular testing approach to verify system installation, functionality, and assurance of its intended use as per system specifications and requirements. We run onsite as well as remote tests for the infrastructure, operational and performance qualification testing.

CSV Consultation

We have highly-experienced consultants in our team to provide you with tailored solutions to develop and implement a computer system, validation program that is compliant and reduces the project lifecycle for your internal team, saving a lot of effort and money for your organization.

Compliance Auditing

Our team of specialists also undertake the setup of continuous compliance and risk oversight to ensure that the system is compliant with ongoing changes. On the other side, our auditing solutions help bring about necessary remediation in the unvalidated legacy systems.

Our Operating Process

Our team works cohesively and follows a streamlined process to deliver superior quality projects within the defined timelines.

Requirements Gathering

We assess the needs for computer validation and develop the project scope and KPIs

Planning

We understand the specification requirements for the system's functionality, performance, and design

Building

Our CSV experts develop the required qualification and testing protocols

Configuring

The CSV process and configuration plan are implemented

Testing

Athorough testing for operation qualification including administration training, user training, etc., is done

Reviewing

Our team continuously reviews and manages specification or system changes

Reasons to Hire FWS as Your Computer System Validation Service Provider

As a trusted validation services provider for global companies, Flatworld has 20 years of industry experience in offering radical solutions for all your CSV needs. Outsource CSV services to us and get access to the following benefits -

Domain Expertise

Flatworld has engineered state-of-the-art validation frameworks and techniques for a wide range of GxP systems to help our clients stay compliant with all the regulatory changes.

Quick Turnarounds

We value your time and ensure faster TAT for delivering high-quality solutions that are in perfect sync with your validation needs.

Cost Savings

Outsourcing CSV services to us will help you save significant costs that you would have otherwise incurred if the process was carried out with an in-house team.

Experienced Team

Our team is highly competent and has a wealth of experience in the qualification and validation of computerized systems based on risk management (as per GAMP 5®), process validation, and quality management systems.

Dedicated Support

We appoint a dedicated project manager and a team for efficient and timely management of your project. A dedicated project manager also serves as the SPOC ensuring that there is enough room for effective communication to understand your business needs and fulfill them.

Other Services You Can Benefit From

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Client Success Stories

FWS Developed a Video Editing App with Advanced Functionalities

We developed a lightweight and agile mobile video editing app by implementing all requested functionalities. The client was pleased with the development quality and considered our services value for money.

FWS Developed an Augmented Reality App to Help Customers Choose the Best Looking Air Conditioner

A London-based seller of consumer products contacted us to develop an augmented reality app and the project was completed as per the SLA. It helped boost sales and revenue for the client.

Client Testimonials

I have really enjoyed working with Devaiah and Kaushik. They are great team players and can really deliver outstanding results. I would be proud to have either one of them on my team in the US.

President of Operations, Digital Marketing Company in Florida

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Outsource Computer System Validation Services To Flatworld Solutions

Flatworld has rich experience in computer system validation and has undertaken CSV projects for custom, off-the-shelf (OTS), and highly configurable ERP computer system applications. We help our customers throughout the validation life cycle by leveraging a multi-disciplinary approach to validate computer systems and mitigate any regulatory or compliance gaps in the systems. You can reach our CSV expert to understand our solutions better. Contact us here .

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Flatworld Solutions

116 Village Blvd, Suite 200, Princeton, NJ 08540

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Aeon Towers, J.P. Laurel Avenue, Bajada, Davao 8000

KSS Building, Buhangin Road Cor Olive Street, Davao City 8000

Important Information: We are an offshore firm. All design calculations/permit drawings and submissions are required to comply with your country/region submission norms. Ensure that you have a Professional Engineer to advise and guide on these norms.

Important Note: For all CNC Services: You are required to provide accurate details of the shop floor, tool setup, machine availability and control systems. We base our calculations and drawings based on this input. We deal exclusively with(names of tools).

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