Together we are stronger. Whether you're a lone consultant out on assignment, on the same assignment as other Plantvision colleagues or working remotely - you always have the whole of Plantvision with you. This is something that Kristina Eneling, senior consultant in Quality Management, values.
"Plantvision is with me as a sounding board if I run into challenges - there is always another colleague who has worked on a similar problem who can come up with good solutions. I also get help with relief or prioritisation if I need it. In some cases, more technical expertise may be needed in the project, and then I can always ask someone 'back home at PV'," says Kristina.
She works as a senior consultant focusing on computerised systems validation management (CSV). As a Validation Manager, her role is to help clients gain control, and maintain the right quality, of their quality-critical systems. Throughout its lifecycle.
"I am involved in new system implementations, change work needed during the management phase and also in decommissioning projects, i.e. how to 'retire' systems and the data they contain when they are no longer needed. I am responsible for producing all validation documentation required to ensure the system is compliant and works for its intended use. I also coordinate various cross-functional resources in the different validation activities," she explains.
In her role as a consultant, Kristina has an important role to play with customers. She is there to make sure they meet the high regulatory requirements that exist in the pharmaceutical industry. Ensuring that they handle quality-critical data correctly.
"I define what is quality critical and what is important for the process where this particular system will be used. I also summarise what the risks are if the system or process does not work as intended. Risk and problem solving is something I am passionate about!" says Kristina.
"By asking supportive questions to the client, I help them get to the core - what is important and how do we ensure that it works properly? Many times, with an outside perspective, I can see other pitfalls than the internal team, and I can then suggest good solutions to the challenges identified," she continues.
Her role is often challenging, but above all fun. Sometimes the client and the business do not have enough time and resources to complete their part of the projects. Sometimes there is also a lack of knowledge. Since they are the ones who have to use the system and work according to the process afterwards, it is a challenge. However, Kristina knows how to approach it in the best possible way.
"Communication has to work. Clear start-up, expectation dialogues and role allocation are key. Everyone must be on board with what is to be done, why, when and by whom - and understand that everyone is working together towards the same goal. Once you have a common picture, frequent follow-ups with a project manager present are worth their weight in gold. Having a clear client and decision-maker with you is also a success factor, otherwise it's easy for the project to go round in circles. For me as a validation manager, it is very important to have a good dialogue with the QA for computerised systems, the project manager and the system owner where necessary," she says.