AdventSys IVAL: Paperless Validation Solution
GoVal: Paperless Validation Solution
GoVal Validation software solution enables the customer to implement paperless validations and fulfill Part 11 compliance from regulatory agencies.
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Why Computer System Validation ?
Good Practice (GxP) standards (such as GMP, GLP and GCP regulations and guidelines) are set by governing agencies such as FDA and EMA for the industries that are regulated. The Life Sciences industry that includes Pharmaceutical, Biotech, Medical Devices and Clinical organizations have requirements set to ensure products manufactured are safe and meet strict quality standards throughout the entire process of production. The companies that come under regulatory purview must have the trained staff to ensure defined quality norms and procedures are followed to ensure GxP compliance. The Life Sciences industry need for comprehensive validation system arises from GAMP guidelines and recommended methodologies for validation of GxP computerized systems.
GoVal Validation Software
GoVal is a comprehensive validation software solution to help the Life Sciences industry organizations to implement automated, paperless validation systems that are governed by GxP compliance. Handling paper based documents is a cumbersome and messy affair, which requires more manual effort and it's often inefficient and costly. GoVal addresses the typical issues associated with document storage and retrieval in controlled and secured environment.
GoVal software offers a way to handle various types of processes associated with the validation processes including:
Master Validation Plan
The details of GxP systems to be validated, identification of validation strategy, and testing requirements can be established in the Master Validation plan.
Project Setup
Validation Master Plan
User Requirements and Functional Specifications
User Requirements (URS) and Functional Specifications (FS) can be defined and mapped in the software in an easy way.
Requirement Specification
Functional Specification
GxP Assessments
GoVal GxP assessment feature helps to determine the correct GAMP category of the system to be validated. It also suggests the list of processes (and documents) to be included as part of the validation process.
GxP Assessment
Risk Assessments
GoVal facilitates the organizations to implement a Risk based approach to validate GxP computerized systems. The testing strategy can be based on risk severity and probability of occurrence of the functional requirements and processes.
Risk Assessment
Workflow Automation
Validation process documents flow through review and approval through workflow automation. The documents are approved with electronic signatures.
Workflow Automation
Vendor Assessments
GoVal Vendor Assessment feature would help the organization to automate the assessment process by the means of electronic questionnaires (external URL) to prospective vendors and receiving the feedback from them.
Vendor Assessment
Test Protocols
Implementation of test protocols Instalation Qualification, Operational Qualification and Performance Qualification can be done with the GoVal software. The testing can be done to cover the risk priority of GxP impacted processes of a system.
Operational Qualification
Requirement Traceability Matrix
Auto generation of Traceability matrix with all test cases , associated risks and requirements after the execution. GoVal also provides discrepancy form details associated with each failed test case associated with each URS.
Traceablity Matrix
Compliance Reports
GoVal generates Validation Summary Report (VSR), System Release Certificate, Part 11 compliance certificate and other reports with a click of a button. The reports are auto generated from validation project / process data. These reports are useful to the organization in fulfilling regulatory compliance requirements.
Part 11 Compliance Report
System Release Certificate
Key features
Life science, more importantly, pharmaceutical companies develop and deliver products to market quickly and safely by using comprehensive paperless validation software solutions that provide data integrity, consistency, control and transparency across the organization.
Process Standardardization: GoVal, Paperless validation software will enforce defined validation processes and related tasks. This would help the companies avoid reinventing the wheel and ensure optimization and efficiency in the validation process.
Always On: GoVal, the paperless validation software ensures the user accessibility anytime, anywhere across multiple devices (Web, Phone and Tab). This facilitates teamwork and ensures the progress of activities, thereby reducing the cycle time for validation.
Paperless Solution: GoVal completely takes away the pitfalls in the usage of a paper-based validation process where more effort & cost involved in doing the activities related to printing, distribution, and storage. The software-based solution leads to an improvement in efficiency and saving costs.
Monitor & Control: GoVal enables the visibility of validation tasks and provides management up-to-date information to monitor and control to improve the processes.
To explore more on GoVal validation software, please visit www.govalidation.com
Want to see a live demo
If you would like to discuss how it can do transformation of your existing process, please contact us