Our Computer System Validation Services Include

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.

1.  End to End Computer System Validation Services:

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.

2.  21CFR Part 11 Analysis and System Remediation:

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.

3.  Validation Testing Services:

Validation Testing Services is an independent service where Swasti Solution 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.

4.  Quality Assurance Review:

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 Swasti Solution is also performing Validation Testing Services.

5.  Conduct and Support CSV Audits:

CSV Audit is conducted periodically preferably annually to check the compliance health of Validated and Non-Validated GxP System. Swasti Solution will conduct the CSV Audit and generate a CSV Audit report along with mitigating steps and procedures. Swasti Solution can also help customers to close on compliance gaps.

6. Computer System Validation Training:

Swasti Solution also provides training on computer system validation that provide an overview of the validation process and best practices.

Other Services

7. Web Development:

Swasti Solutions 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.

8. App Development:

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.

9. Software Development:

CSV Audit is conducted periodically preferably annually to check the compliance health of Validated and Non-Validated GxP System. Swasti Solutions will conduct the CSV Audit and generate a CSV Audit report along with mitigating steps and procedures. Swasti Solutions can also help customers to close on compliance gaps.

10. Manpower Staffing:

Swasti Solutions 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.