Niamex.com is able to meet all your Computer Validation Service’s needs. Our services include:
- Identifying the most appropriate validation and test strategy to match you application and business needs.
- Carrying out GxP classifications and Risk Assessments.
- Developing and preparing policy, plan and procedure documents to meet the appropriate strategy.
- Developing and preparing commissioning and qualification documentation.
- Performing Vendor/Supplier audits.
- Verification of Vendor Testing.
- Supporting Vendor lifecycle where deficient.
- Developing and executing of test protocols.
- Performing QA activities to oversee supplier software development.
- Conducting Gap Analysis studies of existing Computer Systems against current industry expectations.
- Remediation of the identified gaps.
- Performing pre-regulatory audit reviews
- Performing 21 CFR Part 11 assessments on computer system
- Performing Data Integrity Assessments against the latest guidelines
In addition, Niamex provides a range of training material and document templates that can be tailored for client needs. Both our training material and document templates are written with GAMP guidelines, EU, and FDA regulations in mind.
If you are interested in this range of material or need something more specific then please email us at admin at Niamex.com.
One of our resident industry experts would love to help you.
Don’t forget, at Niamex, our aim is to provide good value, practical advice and to seek a long-term relationship with our clients. If you feel we can be of service to you, please contact us