Ensuring your computer systems are cutting edge is a critical factor in beating your competition. This can be achieved only with a modern and fast computers system validation (CSV) framework.
Our e-Validation Platform (eVP) designed to comply with the requirements set by ISPE GAMP 5 second edition based on Atlassian Confluence and Jira is a milestone of validating computerized applications to ensure they meet the requirements of GXP.
Our e-Validation framework is a critical step in ensuring that electronic applications, processes, equipment, cleaning and monitoring are reliable, accurate, and complete. It helps to prevent data integrity issues and ensures that the computerized systems, processes, risk assessments and project management are fit for their intended purpose by a holistic and comprehensive approach.
There are several key steps involved in validation according to ISPE GAMP 5 second edition with Atlassian Confluence and Jira:
- Planning and Scoping: The first step is to plan and scope the validation project. This involves identifying the scope of the project, defining the objectives, and establishing a project and validation plan.
- Process, Data and Risk Assessments: Several levels of assessments should be conducted to identify potential risks to data integrity and to develop mitigation strategies.
- Design Review: The design of the computerized system should be reviewed to ensure that it meets the requirements of GXP processes and requirements.
- Development and Code Review: The code of the computerized system should be properly developed and reviewed to ensure that it is written according to best practice standards. This does also contain development test phases like unit, integration, and system testing before the release of a system version or patch.
- Installation and Configuration: The computerized system should be installed and configured according to the approved specifications.
- User Acceptance Testing (UAT): The computerized system should be thoroughly tested by users to ensure that it meets their needs and expectations.
- Formal Documentation: Formal documentation should be generated to document the validation process during project and operational phase.
- Ongoing Monitoring: The computerized system should be continuously evaluated and monitored to ensure that it remains compliant with GXP.
Atlassian Confluence can be used to support the e-Validation process in several ways. It can be used to:
- Store and manage e-Validation documentation: Confluence can be used to store and manage all of the validation documentation, including risk assessments, design reviews, code reviews, UAT reports, and formal documentation.
- Track e-Validation activities: Confluence can be used to track the progress of the e-Validation project and to record key milestones.
- Communicate with stakeholders: Confluence can be used to communicate with stakeholders about the e-Validation project and to get their feedback.
- Building a bridge between contract giver and contract acceptor (e.g.: development and configuration by supplier with Jira).
- Implement ISPE GAMP®5 SE and Enabling Innovation requirements (e.g.: tools instead of documents, acceptance instead of approvals).
- Use AI testing tools with Confluence for automated system and user acceptance testing.
- Automated creation of Fit-Gap Analyses and Traceability Matrix.
- Extend your Validation Master Plan with process, cleaning, equipment, utility, facility, and method validation and qualification.
- Enables a total framework for project, process, risk, validation and supplier management and collaboration (e.g.: electronic Logbook Management, bridge to SOLMAN and eDMS/eQMS).
- Fully inventory management (extension: CMDB), ITIL tools including patch and release history.
- Compliance with EU GMP EudraLex Volume 4 Annex 11 and Annex 15 and US-FDA 21 CFR Part 11, GCP (EMA, FDA), GLP (OECD), GDP
Our CCS paperless validation approach is designed for reducing validation and qualification efforts.
Using our eVP with Atlassian Confluence in the entire validation and qualification process can help to improve efficiency and compliance. It can also help to reduce the risk of data integrity issues.
A slow computer systems validation (CSV) is a roadblock on your path to success: It delays the deployment of improvements, the assessment of their impact, and ultimately, their value to your business. A quick feedback loop continuously drives better ideas and fuels your business with powerful breakthroughs.
What makes your solution unique? We do not offer a dedicated digital or electronic validation system; we offer a highly extendable platform approach close to software developers and system configuration and a high degree of regulatory compliance. With our certified global Atlassian Solution Partner we can provide a fitting solution to any client and meet highest expectations.
What to do next? Contact us today at talk@comes-services.com
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