We are delighted to announce our brand new white paper – ‘A Rules Based Approach to Labelling and Artwork Management’. The paper discusses how organisations can eliminate many of the repetitive manual processes that consume unnecessary time and may lead to non-compliance through human error and fatigue.
Commonly overlooked as more of a cost overhead rather than a core business activity, labelling and artwork errors can have serious consequences. Managing the decision-making process as a set of business rules allows for more responsive updates and revisions. It also ensures greater levels of consistency and helps shorten time to market.
The paper highlights the benefits of adopting a rules engine to underpin the labelling and artwork process and in particular the reduction of errors and increased levels of productivity, for heavily regulated industries such as pharmaceutical, chemical, cosmetic and medical device manufacturers.
Are you interested in learning more about how Kallik’s solution can simplify your labelling and artwork management process?
Implementing the upcoming European Unique Device Identifier will require considerable investment and strategic planning for many organisations. Currently, much of the medical device industry is quite rightly focused on understanding the impact of the legislative framework and being in a state of readiness to populate the EU equivalent of the GUDID, this being EUDAMED (European Database on Medical Devices) by May 2020.
At Kallik, we also see the EU MDR as an opportunity for organisations to review the effectiveness of their current labelling and artwork processes and how digitalising supply chains can strengthen compliance and simplify evolution toward e-Labelling.
In our latest publication produced in conjunction with IQPC, we discuss how labelling digitalisation enables more robust regulatory submissions and increases transparency of enterprise-wide review and approval processes. We also look at how this can simplify integration of extended supply chains and shorten time to market during periods of mergers and acquisitions.
Join us at UDIs & Traceability May 15 -17 2018 Amsterdam to meet the Kallik team and to hear from more on this topic from our CEO, Neil Gleghorn.
Feel free to also visit and subscribe to our blog pages where you can keep up to date with the latest innovations in labelling and artwork management and discover how we can help you stay compliant.
How joined up is your labelling?
You may have heard or read that here at Kallik we believe the only effective means of managing the plethora of labelling changes driven by regulatory changes, product updates and entry into new markets is to work from structured content. It’s no surprise others agree with us on this point. Serialisation, UDI and IDMP each require a more granular approach to managing labelling content. It’s not going to be easy to adapt to change if you stay rooted in a document centric world. The only workable solution will be to embark on your document to data journey and we’re here to help you plan your itinerary.
Before we do that, we felt it would be valuable to share our vision and help you to visualise a world where everyone involved in the labelling and artwork process – from Regulatory Affairs to final print production – is fully connected and empowered to execute their roles. Working with one of our key partners, DXC Technology (formerly known as CSC), we’ve created a brand new white paper that both talks to the issues and presents the case for change.
We also know that success is more than choosing the right technology. It’s about creating an environment that encourages greater collaboration and ownership right across the supply chain by making life easier for the user. We’re hoping that this white paper goes someway to showing you what can be achieved once you take the first step in joining up the dots across you’re labelling estate.