Over the next few months we're planning on making some major changes to our website and the services we offer, plus we're currently working towards ISO 9001 certification.
To make sure we provide the best service possible we'd like to know more about who visits this site, so would appreciate it if you could tell us what information you were after when you landed on this site, and something about your own background. This information will be used to tailor what information appears on this website, and how it will be structured.
Our current thoughts are structuring the site aimed at supporting Pharmaceutical and Medical Device company end users when they have to implement and maintain computer systems validation (CSV) for compliance on new and existing projects; the other would be supporting Suppliers to the Life-sciences sector (for example ERP suppliers, automation integrators, plant equipment suppliers, and laboratory equipment suppliers) about how they can leverage their existing documentation and procedural systems to provide what their customers need to implement and maintain a compliant computer or control system.
There are a couple of quick polls below to collect this information if you've a few seconds to spare, and if you would like feel free to sign up for our periodic newsletter where we'll keep you informed as our website develops. If you are looking for services or products not listed below, or have a different background to the job descriptions below, we'd appreciate any feedback you can provide us via the 'Stay Informed' window below.
Based in the North West of the UK, CSVuk provide Computer Systems Validation (CSV) Services to the primary and secondary pharmaceutical industries in the UK and Europe, which are regulated by the Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA).
We have a proven history of providing high quality, cost effective validation solutions to meet our customer needs in the biotechnology, active pharmaceutical ingredient (API) and medical device industries; with a range of experience through project management, engineering design, risk assessment, and validation (prospective and retrospective).
We frequently undertake assignments to complete prospective and retrospective computer systems validation of manufacturing and laboratory equipment, perform GMP audits of existing computer systems, risk assess new and existing computer systems, and review/enhance CSV policy in line with current regulations and regulatory guidance. We also give added value by managing technical fixes, provide technical detail for inclusion in Operation and Maintenance (O&M) manuals and Standard Operating Procedures (SOPs), and offer technical support to production departments whilst operators are being trained.
Our associations with similar CSV Consultancies and Engineering Services companies in the UK and Europe enables us to provide single consultants and teams of consultants on short-term and long-term assignments at competitive market rates.
If there's anything you would like to see covered on this website please send us your comments via the 'Stay Informed' window at the top of the page.