ArticleQuality Excellence
Streamline your operations with a team of validation experts
In today's complex and fast-paced business environment, quality assurance has become a crucial factor. The demands for quality assurance, validation, testing, and documentation are increasing, and for many companies, it is challenging to keep up with new requirements while maintaining the right expertise. Semcon offers a solution to both problems – taking responsibility for the entire validation and testing delivery.
As industries become more complex and technological advances accelerate, the need for thorough validation processes becomes essential. Companies must be able to ensure that requirements are met, trace back if something goes wrong, and prove that they will always achieve the same results. For companies operating in highly regulated industries such as life science, validation is a critical process that ensures quality and compliance with regulatory requirements.
"Semcon's strength is that we are flexible and cost-effective. Our teams are made up of validation professionals, and when they get involved early in the project and take responsibility for both strategy and delivery, it has a positive impact on the entire project," says Jessica Heed-Lövgren, Key Account Manager at Semcon.
The right validation expertise when needed
Validation is not just about creating important and necessary documentation; it leads to quality being built into the entire process. However, this is easier said than done for most companies. The biggest challenge is having the right competencies internally, something that is often not even possible.
"The fact that these processes require different competencies at different times, makes it difficult for companies to be efficient. Often a specific resource is needed for a short period, but if that person is tied up with other tasks – which is common – the validation process comes to a halt," says Josefine Göthe, Area Manager at Semcon.
This is a strength in Semcon's offering, we take responsibility for bringing the project to completion from start to finish. This means that the team itself is responsible for keeping the process moving forward, including bringing in the right expertise exactly when it is needed.
One of our biggest strengths is our flexibility – we ensure to meet all needs that might arise along the way.
"We have a large number of consultants specialised in validation and we also have access to experts in various fields. One of our biggest strengths is our flexibility – we ensure to meet all needs that might arise along the way. We see ourselves as a partner to our customers when working together on projects, and it is absolutely crucial for us to always ensure that the work does not slow down or stop," says Josefine Göthe.
The importance of being involved from the start
Semcon has developed a structured process for team deliveries that includes three key elements:
Early involvement in the project
Setting requirements for suppliers
Continuous adjustment of the team composition according to project needs
At the same time, every project is unique, and therefore an adapted plan and a high level of flexibility are needed to make the process as efficient as possible.
"We always look for the best solution for each individual project and don’t believe in forcing a project into a predetermined plan. It might seem easy to decide on an approach right away without much thought, but it always backfires later on," says Jessica Heed-Lövgren.
More industries focus on validation
The value of early and high-quality validation expertise has spread and is becoming increasingly common in various industries. The reason is that it streamlines processes by getting it right from the start. Since the significant value created by a validation expert is not based on a specific industry but rather on ensuring that requirements are met, validation can contribute greatly in virtually any industry.
"Today, we work a lot with major pharmaceutical companies and companies that manufacture medical devices. But we see a trend where more industries are recognising the value that professional validators create. This includes nuclear power, food, energy producers, process industries, and manufacturing industries," says Josefine Göthe.
Skilled leaders are crucial
When Semcon takes on a validation project, a senior leader is always involved from the start. This ties into the importance of finding the best solution for each project, which is a specialist skill. Once the strategy is set, the amount of team members can be scaled up or down depending on which phase the process is in. At the same time, there is always a leader responsible for the entire delivery, ensuring the right resources are in place at the right time and checking in with the customer's steering group.
Validation is demanding, which is also what makes it so enjoyable.
"Beyond strong business acumen, we place great emphasis on our leaders' 'human skills.' Validation is demanding, which is also what makes it so enjoyable. But it is crucial that the leader can create and maintain a strong team spirit and ensure that everyone feels good and functions optimally throughout the process," says Jessica Heed-Lövgren.
Semcon’s team leaders are trained internally and are hand-picked from our consultants with the highest competence in validation. During the selection process, great emphasis is placed on the individuals’ ability to lead and see people, as this is crucial for both quality and efficiency.
"We have a great team spirit in our teams, thanks to our leaders. It is not uncommon for customers to point this out and say that it is fun to work with us," says Josefine Göthe.
With the right validation team, your company gets:
More efficient projects
Cost-effective validation
Correct requirements and documentation at every stage
Access to experts at short notice
The ability to leave responsibility for validation to Semcon’s experts
