Regulatory IT Compliance || Data Integrity || Computer System Validation || Enterprises System || Computer Software Assurance || Agile Methodology GAMP 5, 21 CFR Part 11, EU Annex 11.

I am an expert in computer system validation and I am offering a comprehensive service to ensure compliance with regulatory standards such as FDA, 21 CFR, WHO, PICS, ICH, and GAMP5 guidelines. My service includes a detailed workflow that covers the following steps:

Step 1: Initial assessment
Identify potential vulnerabilities and non-compliance with regulatory standards
Identify areas for improvement

Step 2: Risk management
Implement risk management measures to mitigate identified risks
Develop risk management plan

Step 3: Validation plan development
Develop a comprehensive validation plan
Define scope, objectives, procedures, testing strategies, documentation requirements, and acceptance criteria

Step 4: Testing and validation
Execute necessary tests, including functional, performance and security testing
Confirm compliance with guidelines

Step 5: Documentation and reporting
Provide detailed documentation, such as validation protocols, test plans, test reports, and summary reports
Demonstrate compliance

Step 6: Ongoing maintenance and monitoring
Ensure ongoing compliance by providing ongoing maintenance and monitoring services
Regularly review and update validation plan.
I will work closely with your team throughout the entire process, providing regular updates and addressing any concerns or questions that may arise. With my expertise and attention to detail, you can trust that your computer systems will be secure, reliable, and fully compliant with the regulatory standards, and that you have all the necessary documentation to demonstrate this compliance.

I am an expert in web development and I am offering a comprehensive service to ensure compliance with that covers the following steps:
Designing and developing the layout, visual appearance, and functionality of websites.
Writing code in various programming languages such as HTML, CSS, JavaScript, and others.
Collaborating with designers, project managers, and other developers to create and implement new features.
Troubleshoot and debug any issues that arise.
Optimizing websites for speed, scalability, and search engine optimization (SEO).
Testing websites and web applications on different devices and browsers.
Keeping up-to-date with new web development technologies and trends.
Collaborating with the team to improve the company's development processes and workflows.