Many GMP, GCP, and GLP environments use spreadsheets for data management but in most cases, FDA requires validation to ensure consistency, accuracy, and reliability of records.
Flatworld is a reputed spreadsheet validation service providing company and has delivered 4500+ validation projects in compliance with 21 CFR 11 and Annex 11. We have a huge team of validation experts, testers, and other specialists to develop the comprehensive validation strategies that you require. We undertake an in-depth examination of your spreadsheet calculations, VBA script, and test macros to ensure that your spreadsheet is compliant, safe, and efficient.
We offer full-stack spreadsheet validation and optimization solutions that can be customized as per your project needs.
Proper categorization allows a quick overview and reduced effort in finding the required documents. Our team takes into account the GxP criticality and complexity factors along with GAMP guidelines to develop a categorization system for the validation of computer-aided systems. We assign spreadsheets under different categories such as risk-based or application-based and accordingly, we deploy the right validation approach for each category.
Utilizing proven functions and macros, we implement the required security functions in MS Excel spreadsheets. The security functions include audit trail, verification functions for input cells to detect errors or fraud, and protection of non=-editable content.
Our team uses proven tools and standardized validation protocols for validation, testing, and reporting. Tools such as SOP and validation protocol are continuously optimized for easier application and improved reliability.
Regular verification of existing spreadsheets becomes vital for risk-based approach validation. Under this, our experts verify the spreadsheets after any change in software or hardware of the computer systems are done. The existing spreadsheets are compared with the standard ones and each verification is systematically recorded and compiled in the validation file for future reference.
As a service provider, we also provide training and consultancy solutions for in-house implementation and adaptation of validation. For employee training, we extend all the know-how of the tools, our expert knowledge, and comprehensive coaching for a better understanding of the validation protocol.
We have defined a modular workflow for validation that involves the following stages -
We brainstorm with the clients to understand their spread validation needs
We obtain all the required information and spreadsheets to create a general layout and data validation rules
We validate the calculations and formulas of the spreadsheets either using commercial software or other standard validation methods
Access rights, protected data, password protection, and other security functions are validated
The entire process undergoes multiple checks for quality assurance
Once approved, the reports and spreadsheets are submitted to the client using secured networks
Hiring us for validation may be the best decision you make. Here is why -
We obtain a high level of efficiency and high-quality output using a streamlined approach and commitment towards faster turnarounds.
We leverage proven macros and advanced tools for validation to ensure proper compliance and functionality.
Traceability, comprehensive inspection, and adherence to security protocols and functions make us a reliable outsourcing partner for validation.
At Flatworld, we boast of a vast and highly qualified team of testers and validation experts dedicated to understanding client needs and delivering custom solutions.
Our services come at flexible prices to fit your unique needs and budgets.
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.
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.
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 More Testimonials »
We offer powerful spreadsheet development, analysis, documentation, and remediation services to solve a wide range of validation issues such as problematic logic, fraudulent practices, security risks, duplication of efforts and data, etc. Outsourcing spreadsheet validation services comes with the assurance of validation accuracy and quality. Contact our validation expert to get started.
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