Validation: why you should outsource to an external party
Validation of your processes, equipment and software: you won’t be able to get around it when you work in the life sciences, healthcare or cosmetics industry. A lot of companies tend to let their own in-house validation team take care of validation activities, including all documentation. However, validation by an independent party is crucial to guarantee a thorough process. You will find four important reasons below:
When it’s not done right, it may just as well never have been done at all. The consequences of poorly validated equipment, software or processes, can cost you a lot of money: you may end up having to solve a lot of problems for a long time. When outsourced, the job is done by people who are not only very qualified and experienced themselves, but who have all the expertise of their colleagues and the documentation of their company at their disposal. That’s why QbD pays so much attention to continuous internal and external knowledge-sharing.
Thanks to its expertise and experience, an external validation partner is able to adjust general validation standards to your specific company and needs. With a risk-based approach, a validation consultant will create tailor-made validation activities to find the balance between being compliant and focusing on what really matters.
An external validation party offers a whole team of validation experts and consultants – each with their own specialism. A consultancy partner is able to offer the right validation consultant for the right subject, such as validation of software (including mobile apps), automation, (lab-)equipment or processes.
Validation work is often project-based. If you outsource your validation activities to a professional, you have the right expertise at your disposal at the right moment. The average validation job requires 30 percent ‘senior’ work: mostly strategy and analysis, done by a very experienced expert. The other 70 percent is work that a less experienced – but well-trained and followed-up – junior/medior can handle perfectly, and maybe even better. So the consultancy you’ll get (and pay for) will be customised accordingly.
“Not all tasks need to be carried out by internal experienced specialists. QbD is aware of this fact, and offers us a customised formula. We get a well-trained junior, assisted by an experienced senior for one or two days a week, and have access to all the available expertise at QbD. It’s the perfect working method.”
– Leen van de Water, Responsible for Quality at Pannoc.