The constant evolution of society and the regulatory system in the pharmaceutical field bring many requirements for industries, which need to go over their procedures and documentation on a regular basis. However, this process can bring many benefits to a firm, by objectifying its quality culture.
Through the frequent changes GMP go under and the evolution of societies - including major preoccupations regarding climate change and the need to maintain customers' trust - quality management systems are also subsequently subject to many changes, sometimes over short-term periods. As regulatory guides establish some basic requirements for different kinds of quality management systems, looking and acknowledging what can be added may have strong benefits to meet regulatory and customers' requirements first, but also to objectify the quality culture of a firm. Being the genuine mirror of its values in terms of image and quality, the quality management system is set by the senior management and meant to be applied by everyone, allowing a global support of the quality culture whose strengths and eventual lacks are highlighted in a systemic way through the assessment of the system.
Calling up an external company to realize an assessment of a quality management system can have many benefits for any company. It is above all an unbiased point of view on the current system, given by someone who does not acknowledge it and who can point out its lacks and needs. It is also an opportunity to bring someone else's expertise and experience to the system and to implement long-term solutions.
Wealthy by the experience and expertise of its experts, Ellion brought up an innovative solution soon-to-be-released to help industries pointing out the needs and advantages of their quality management systems. Alongside the senior management and while listening to their concerns either on specific or multiple departments, experts can suggest global improvements to some points requiring specific attention, to upgrade the whole system according to the firm’s needs and resources.
Meant to accompany the firm and to be built with its managers, this solution consists in four steps:
Identification of the company (sector, size, requirements, etc.) and discussion with its representants to point out some areas in need for improvement;
Analysis of the situation by an expert, who will assess the system globally and check if some lacks are showing or if optimizations can be operated;
Presentation of the results and establishment of a cartography of the quality management system, its potentials and strengths;
Proposition of a solution regarding the system and including tools for a long-term improvement of the firm’s quality culture, by suggesting how to enhance the advantages of the system and minimize its fragilities.
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