AdventSys IVAL: Paperless Validation Solution

Paperless Validation Solution

AdventSys Computer System Validation (CSV) enables the customer to implement paperless validations which are complaint to CFR21 Part 11

AdventSys Ival-Paperless validation IT solutions

Why Computer System Validation ?

The validation is an important assessment and necessity in Life Science especially the pharmaceutical industry to ensure compliance with cGMP guidelines and to help the organizations maintain consistent quality. The same principles are applied in Computer System Validation (CSV) a.k.a paperless validation to a computer system or an Information Technology (IT) system. It’s essential & important to maintain quality standards in the pharma and Life Science industries since non-compliance can have severe consequences. Computer System Validation helps the effective implementation of the validation program and meeting the goal for which it was designed.

GoValidation - Computer System Paperless Validation (CSV) for Pharma and biotech companies!

Computer System Validation (CSV)/Paperless Validation is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines for a certain industry.

It is important and critical in industries like biotechnology, clinical research and pharmaceutical that are regulated by FDA.Since the products, and services from these industries are impacting public health and safety. GoValidation is a user-friendly CSV software for pharma and biotech companies to implement robust CSV process in their organization.

Handling documents is a cumbersome and messy, which require more manual effort and its often inefficient. GoValidaiton addresses the typical issues associated with document storage and retrieval in a controlled way.

GoValidation offers a way to handle various types of validation documents such as User Requirement Specification (URS), Design Specifications, Standard Operating Procedures (SOP), Calibration Reports, Test Reports. The documents are controlled and stored Document Management System (DMS) and controlled through work flow approval processes i.e., how the change is originated, reviewed and approved. GoValidation also offers requirement traceability and audit trial features which are very much helpful in successful execution of validation process.

adventsys-paperless-validation
adventsys-paperless-validation

Key features

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.

goval paperless validation Standardization

Process Standardardization: GoValidation, 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: GoValidation, 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: GoValidation 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: GoValidation enables the visibility of validation tasks and provides management up-to-date information to monitor and control to improve the processes.

paperless validation

Types Documents

GoValidation can handle different types of artifacts with configurable workflow:

    Project setup

    Project Setup

    Project setup

    Validation Master Plan

    Project setup

    Requirement Specification

    Project setup

    Installation Qualification

    Project setup

    Operational Qualification

    Project setup

    Performance Qualification

    Project setup

    Project Plan

    Project setup

    Risk Assessment

    Project setup

    Traceability Matrix

    Project setup

    Validation Summary Report

    Project setup

    Vendor Validation Document

paperless validation

Visit product showcase website GoValidation at:

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