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Shreevrunda Tech Integrity established in 2024 with objective to provide knowledge based end to end IT compliance solution. Shreevrunda Tech Integrity employ a risk-based approach to the computer system validation (CSV) process ensuring the right amount of testing and documentation is undertaken. This approach to CSV saves our clients considerable time and money when implementing electronic systems. Our industry demands continuous product innovation, cost control, and compliance to various regulatory and statutory requirements. Validation of computer systems is not a once off event. Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and modifying.
Quality has a progmatic interpretation as the non-inferiority or superiority of smetheing: It`s also defined as being suitable for its intended purpose while satisfying customer expectations.
Our team of validation experts will work closely with your QA and IT teams, as well as software vendors to ensure that a coherent validation strategy is implemented in line with quality requirements, available resources and associated risks with the system.
Our expert team ensures seamless hosting performance, security, and exceptional customer support
Our Team has an array of expertise to expand your capacity and capabilities, and draws from their vast knowledge base to custom tailor solutions unique to your project needs.
Our CSV services can enable you meet global regulatory requirements and help you reduce your compliance risk. We understand the cost of validation and its impacts on the healthcare cost. We provide utmost commonsense in our validation approach and employ strategies that effectively leverage processes within the clients, thereby reducing the cost. We provide utmost importance to Quality in the deliverables and deliver within the specified timeline.
Offered for any GxP sensitive computer system implementation, development, upgrade, and rollout project, services include: IQ, OQ, PQ with all other validation deliverables as per GAMP 5 standards. The services also include GxP Control Mitigation and 21 CFR Part 11 Analysis.
21 CFR Part 11 Analysis and Remediation is conducted as part of CSV end to end validation services or separately if 21 CFR Part 11 compliance is not implemented. 21 CFR Part 11 is also referred to as Electronic Records and Signatures and is mandatory for FDA regulated industry to comply.
Validation Testing Services is an independent service where shreevrunda provides functional resources with the relevant functional and CSV expertise to execute validation testing of GxP System and ensure objective evidence in form of proper documented evidence adhering to Good Testing and Documentation Best Practices. Validation Testing Services can be offered as part of CSV end to end services or a separate service and can also be executed 100% offshore.
Quality Assurance (QA) Review service is an independent service offering for review of all Validation deliverables. QA Review service can also be offered during Validation Testing with independence of Review maintained if shreevrunda is also performing Validation Testing Services.
CSV Audit is conducted periodically preferably annually to check the compliance health of Validated and Non-Validated GxP System. shreevrunda will conduct the CSV Audit and generate a CSV Audit report along with mitigating steps and procedures. shreevrunda can also help customers to close on compliance gaps.
Shreevrunda also provides training on computer system validation that provide an overview of the validation process and best practices.
Shreevrunda offers comprehensive web development services, creating dynamic and responsive websites tailored to your business needs. Our team ensures robust, user-friendly, and SEO-optimized web solutions to enhance your online presence.
We provide end-to-end software development services, building custom software solutions that address your specific business challenges. Our expertise spans various industries, ensuring scalable and secure software that meets your requirements.
CSV Audit is conducted periodically preferably annually to check the compliance health of Validated and Non-Validated GxP System. shreevrunda will conduct the CSV Audit and generate a CSV Audit report along with mitigating steps and procedures. shreevrunda can also help customers to close on compliance gaps.
Shreevrunda offers manpower staffing services to help you find skilled professionals for your project needs. We provide qualified and experienced personnel to ensure your projects are completed efficiently and effectively.
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Explore More4, Dhanvantari Marg, Freeganj, Madhav Nagar, Ujjain (M.P.)
shreevrunda@outlook.com
+91 9869117201
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