Validation Outsourcing

In today's competitive world, many companies are choosing to outsource their validation projects / tasks. Validation Outsourcing allows easy scaling of the validation resources to meet changing business demands, such as a new capital projects or staff shortages.

Most companies have already trimmed their "fat" out of the organisation and are operating with lean departments. When a staff member leaves unexpectedly, critical work is often left undone.

Whilst it is critical to maintain the balance between retaining knowledge of your specific processes and idiosyncrasies of your technologies, it is important to cross pollinate between your company and others, to ensure best in class practice and the cost effective validation.

In many smaller companies, validation is often assigned to personnel who do not have the time, knowledge or experience to handle them. As a result, staff have to start with blank page (computer screen) and generate validation protocols and templates from scratch! This is not cost effective.

Most staff know that they have to generate a -

It would be great for your staff to have access to validation protocol templates for generic equipment, i.e. autoclaves, balances, HPLC, tablet presses, packaging lines? Can staff really make an objective risk assessment, if their experience has only ever been sterile manufacturing and can they adapt to Solid Oral Dosage requirements? Risk judgement is about understanding the full range of products and applying the appropriate GMP Risk assessment.

By having off the shelf protocols and the involvement of an independent risk assessor, validation costs can be dramatically reduced and whilst maintaining GMP compliance. 

Validation Outsourcing is not limited to smaller companies. Multi-national's with large, established Validation departments often need to overcome staffing shortages, have their staff trained or obtain independent advice.

Whatever your situation, we can ensure regulatory compliance, enhance your business process and quality systems, and most importantly, allows you to concentrate on your core business.

Our Validation Outsourcing services include:

Why choose PharmOut for your validation outsourcing?

Contact us for more information about our validation outsourcing services.

Validation, GMP, Consultants quality management systems GMP, GLP training validation jobs TGA, Medsafe, FDA
 
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