Qualification & Validation
In highly regulated industries such as pharmaceutical, biotechnology and life sciences, having Qualification and Validation (Q&V) carried out to the requisite standard is a mandatory requirement.
The documented evidence provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics. Yet achieving this can be challenging.
Regulatory requirements are constantly changing, and the need for maximising efficiency has never been greater. Yet despite the critical nature of Q&V, many companies lack the in-house expertise and resource to undertake this sufficiently and so turn to Q&V specialists.
At Scitech, we have a large team of qualification and validation consultants available to provide guidance on all aspects of Q&V. Our team holds extensive experience, knowledge and technical expertise developed over many years servicing the pharmaceutical, radio pharmaceutical, biotechnology, diagnostics and life science industries. We can provide support for the full validation life cycle whether that be the traditional V model, or a more risk-based approach.
We will support and guide you throughout your project and will ensure that all work is focused where it is needed and where it adds value.
In accessing our specialist Q&V services, you will benefit from:Read more
- Full Q&V support. Our consultancy covers all aspects of the validation lifecycle as they relate to facilities, utilities, equipment, CSV, plus cleaning and process -qualification.
- Time critical delivery. We have experience of scoping, managing and successfully delivering C&Q projects where the construction and commissioning of the facility and utilities largely drive the project timelines.
- Specialist expertise. We have vast, high calibre experience within our team which means we can place the right experts on your project, tailored specifically for your needs.
- Resource plugging. If you have a specific gap in resource or knowledge within your team, we can provide embedded client resources.