How should you, as a company, think?
In Life Science; MedTech, IVD, Pharma and Biotech, there are clear requirements, rules and laws to adhere to in order to maintain the right quality and this naturally places even greater demands on the correctness of the information and data circulating.
Först gäller det att göra en ordentlig riskbedömning. Vilka utmaningar står företaget inför? Vilken typ av information finns att tillgå? Vilka krav ställs för just din verksamhet? I den initiala riskbedömningen är det viktigt att definiera vilka områden och data som är kvalitetskritiska och inte. Ibland pratar man inom Life Science om GxP-kritiska data, detta hänvisar till de regelverk och riktlinjer som reglerar företag inom Life Science med verksamhet inom exempelvis forskning och utveckling, tillverkning och distribution av läkemedel och medicintekniska produkter.
So, for a company that is going to implement an ERP system, it is often about starting by taking a step back and trying to understand the overall picture. In the initial planning, it is very important with risk assessment and the requirement setting that then follows. It is always a good idea to try to find a supplier who has knowledge of ERP systems and an understanding of the industry that your company is in. To be able to carry out all the next steps, it is good to have a good understanding of validation and qualification of computerized systems. Sounds complex? Sometimes it can be, but we're here to help - every step of the way.
Implementing ERP systems, especially in a regulated Life Science environment, which is governed by, for example, GMP, medical device directives or other GxP regulations, is a bit special because there may be modules and data that affect the quality of the products, i.e. quality-critical, while other parts, such as accounting or HR, are more business-critical.
Tips from our experts
To give us a validation manager's perspective, we had the opportunity to talk to Paulina Jasharaj, Specialist Consultant in Computerized Systems Validation.
What is the most important thing to keep in mind when faced with implementing ERP systems?
- Remember that ERP systems are often large and complex systems, which will most likely be used by several different departments within the company and it is important to involve the business in the project. It is also important to work cross-functionally and define which parts you intend to be quality critical and thus which modules and data need to be covered by the validation to find a reasonable level.
What are the most common flaws and do you have any stall tips related to them?
- ERP systems are often highly configurable, in other words, you can customize as much or as little as you want. A common trap is to try to customize the system so that it reflects your previous process as much as possible. If you do this, however, you risk complicating both validation and subsequent lifecycle management and administration. One tip is to try to follow the standard layout of the system as far as possible and only configure what is critical to your business. The fewer changes in code and special configurations, the easier it will be to validate/qualify and then manage the system!
Is it important for you, as a validation manager, to get in early in a job of this type and why?
- Absolutely! As a validation manager, you should already be involved in the first life cycle phase of the system: Concept. In this phase you have not yet chosen your system, but you define the business requirements for the system and make an initial risk assessment. If you do not have a validation resource involved in this step, the risk is that you buy a system that is difficult to quality assure or that ultimately does not live up to current regulations and requirements.
From validation manager to project manager. We also took the opportunity to ask Magnus Färnbäck, Consultant PVCU Celsius, about his role as project manager in ERP projects.
When you, or your colleagues, are asked to do an ERP implementation in a GxP environment, how do you organize the project, where do you start?
- As with any project, planning in the early stages of the project should never be underestimated. The cliché is true, the time you spend at the beginning of the project thinking about requirements and business needs is earned back later, and will be recovered at the end of the project. It is also important to create an understanding throughout the company of what resources will be required and that it takes time to implement an ERP system. It is important to work on a really good set of requirements and think about the actual needs you have, which you have again later.
What are the most common challenges during a project of this kind?
- One of the major challenges is to ensure that the requirements are correct and that both the suppliers of the system and the end users are involved. ERP systems are complex and require both adaptation to the business and training of end users, which takes a lot of time. It is important that users are involved early in the process and that all parts of the company are involved. It is also important to spend time finding a supplier who has previously worked in GxP regulated businesses and who has an understanding of data integrity requirements, GAMP and testing and validation and who can provide support throughout the project.
How can we at Plantvision our customers?
– Plantvision offer support throughout the entire project. We have knowledgeable and experienced staff, including project managers, validation managers, and QA support, who can provide assistance from start-up to commissioning. We also have a wealth of shared knowledge and expertise gathered among our consultants throughout Plantvision in itself can be a valuable support to the team working on various assignments and projects.
Why should you seek assistance from us at Plantvision?
- Because we don't just come into a project with a specific consultant, we can offer teams of 2-3 people and you can also access Plantvision's collective knowledge base, with as much experience as you want.
Want to know more about how we can help you and your business? Do not hesitate to contact one of our experts. What we can provide today will transform your company's efficiency and processes tomorrow. And beyond.