Independent QA Support & Services

Large and small organisations have recognised the need for a strong, competent and independent Quality Assurance function. It is not only because regulations such as ICH GCP call for an independent QA function, but more and more organisations have realised that sustainable quality, “right first time” and Quality by Design (QbD) approaches are essential elements for an efficient and effective business model.

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Operational Excellence as defined in 6-Sigma results in sustainable cost savings because avoidable process redundancies and product rework are avoided: while the cost of goods or services decreases, quality increases. Smaller organisations in particular, face a dilemma when planning to introduce a QbD or operational excellence approach: a strong QA function is needed but hiring a full-time QA person may not be financially justifiable. Finding skilled and experienced QA experts to take on a part-time role is almost always a “mission impossible,” or, if successful, saddles the organisation with high costs since such experts are rare and sought after by large and smaller enterprises. Hiring a more junior QA person will on the other hand not bring the required expertise nor bestow the QA function with the necessary authority. If in spite of all these odds when a suitable candidate is hired, retention becomes the next challenge.

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How can Widler & Schiemann assist you with your Quality Support priorities and needs?
Widler & Schiemann have a demonstrated track record of successful implementation of QA plans and strategies as well as CAPA programs and QA infrastructure and organisations. In the past they successfully coached experienced and junior colleagues in defining and leading straightforward and complex QA projects and activities. As a result of this support, teams and project responsibles proactively sought their advice and asked for the services of the CQA function.

Widler & Schiemann will work with your management to identify what the short-, mid- and long-term sourcing strategy for the QA function should optimally be, what is an optimal set-up for your QA function, and whether an in-sourced, an outsourced vs. mixed solution is more efficient and effective. If reliance on less experienced or part-time QA staff is determined to be the most effective approach, Widler & Schiemann can coach and train your staff at regular intervals, work with them to develop coherent and state-of-the-art QA plans and strategies and actively accompany them throughout the implementation and completion.

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