Our Computer System Validation Services Include

 

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 eValQC 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 eValQC 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. eValQC will conduct the CSV Audit and generate a CSV Audit report along with mitigating steps and procedures. eValQC can also help customers to close on compliance gaps.

6) Computer System Validation Training:

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

7)   Support in Software product development, procurement, selection and Implementation

8)   Support in establishment of Organizational Computer System Quality Management System for GxP IT System

Benefits of Our Computer System Validation Services.

  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.