Validation Services

Our Validation Services

 

Do you need help with your equipment qualifications?

Do you need help with auditing?

Do you need experienced QA, QC and Validation engineers?

Velopi can provide customers with the technical and management expertise needed to deliver projects. Either on-site with the customer or off-site; we provide an experienced, flexible & cost effective solution to either short term or long term needs. We provide a wide range of services to the Pharmaceutical & Medical Device industry globally.

Computer Validation

Do you require Computer Validation services. Utilising a risk-based approach to computer validation has been widely adopted within the Pharmaceutical and Medical Device industries. Testing computer systems for problems and providing evidence to prove this is essential. Our Computer Validation service is wide-ranging and targets only GxP critical areas. We assure that systems are thoroughly tested in a risk-based environment and gathered evidence is documented ensuring your computer systems are compliant with industry standards.

Regulatory Auditing Services

Do you require an audit of your systems for regulatory compliance. We offer a wide range of regulatory compliance auditing services to the following sectors; Medical Devices, Computer Software, Pharmaceutical and Information Technology. We tailor our auditing services to match your compliance requirements and can implement an audit to the appropriate standards and determine if your systems achieve compliance and if not, what is required to achieve regulatory compliance.

Process Validation

Process validation is a requirement in the medical device manufacturing industry. Process Validation is necessary when you do not verify everything the process produces. We can identify the range of process inputs in manufactuering that assure the process produces only conforming product.

Equipment Validation

Demonstrating that a procedure, process, and activity will consistently lead to the expected results often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements to thoroughly document the equipment validation process. We offer Equipment Validation services to the Pharmaceutical and Medical Device industries.

Professional Outsourcing

Velopi's outsourcing consultants can provide seconded staff to cater for your organisations needs and requirements at all levels from graduate to senior management. Our outsourcing solutions can assist you in handling excess workloads and to control costs, improve service performance and offer increased levels of flexibility in workforce management.


Part11 Computer Validation

Have you got an FDA audit of your computer systems validation coming up? Do you need to know if 21 CFR Part 11 or 21 CFR Part 820 applies to you? Do you need software validation help or expertise? Are you concerned about electronic signatures?

We can help you! Contact us to discuss your software validation needs. Answer your questions and put these concerns away for once and for all.

Do not rush into validation. It costs time and money.

Read more about our Risk based approach to Computer Validation 

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