Knowledge-sharing increases the client value
It was with this belief I and my close colleagues started the “Validation Management Initiative”, to share knowledge and foster collaboration. Consultants with validation responsibility all have different experiences. Some have worked with large-scale production lines, unique in the world. Others with auxiliary equipment, designed to serve an oft-forgotten but just as a critical part of the process. A subject one consultant might have just stepped into, another has worked with for years. By arranging and participating in digital workshops and presentations, we share information freely within Knightec. An extra effect is that it brings colleagues closer together so that there is always somebody to turn to when the need arises.
For example, a new draft of the Eudralex Annex 1(*) was published this year, detailing new qualification routines for clean rooms and relevant media systems. With an experienced consultant sharing his/her knowledge via a digital platform, Knightec consultants across Sweden are better equipped to handle the oncoming challenges our clients will experience. Combining the stronger knowledge base with the consultants’ ability to perform, time and cost is reduced as well as the feeling of frustration that can hamper progress.
We want the clients to know that they are not limited to the expertise and experience of the individual consultant alone, but also the accumulated knowledge of Knightec. And we want the assigned consultant to feel that they are not alone, that they have the backing of colleagues who have overcome the same challenges. We do this together.
Validation is more than just “work”
Documents are tangible evidence of quality assurance, but what truly matters is the value added to the product, the process and ultimately, the user. With validation, I can make a difference to my clients, to my colleagues and to the users affected by my work. Which is why I see validation as more than just “work”.
Author
Hung Nguyen works as a senior consultant within validation and has many years of experience of validation and qualification in the Pharmaceutical Industry. Hung is a member of the Validation Management Initiative, working to deepen Knightec’s competence within Validation Management.
References
(*)European Commission. (2020). Second targeted stakeholders’ consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4. Available at: https://ec.europa.eu/health/medicinal_products/consultations/2020_sterile_medicinal_products_en (Accessed: 2020-09-25).