My previous article discussed the organisation and governance required to the support the labelling and artwork process. In this article I will look at different aspects of technology and how they can be deployed to enhance the effectiveness of the labelling and artwork capability.
Technology is a necessary and useful part of any packaging, labelling and artwork capability, indeed it is practically impossible to operate an artwork capability today without some elements of technology.
Technology helps address many issues which can lead to improvements in compliance, performance and cost. Some of these issues include:
Eliminating human error, particularly prevalent in transcribing information and in proof reading
Ensuring everyone has the right, up to date information available to them when they need it
Ensuring process adherence
Aiding coordination of the different people involved
Helping individuals manage their own activities better
Reducing lead times
Before I go on to discuss any specific IT capabilities, let me just pause to cover some of the potential downsides of technology. Before selecting and implementing any technology, the full implications and costs should be weighed against the benefits. Some of these costs include:
Initial and ongoing cost of tools and software
Systems maintenance and support capabilities
User education, training and support capabilities
Impact of the technology on other business processes
For the purpose of discussion here, I will break down the packaging labelling and artwork related technology into a number of sub-groups. I will briefly describe each of them and you will find a more detailed discussion on each of them in our book, Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities.
You should be aware that the solutions available from different vendors often provide functionality which crosses two or more of these areas and I expect this trend will continue over time.
The tools necessary to create such things as documents, artworks, drawings, 3D visualisations and the associated components such as barcodes, Braille etc. Generally, this technology is available off the shelf and the principle issues in implementing them are deciding and controlling which of the many configuration options are used.
The tools necessary to securely store documents, ensure versions are managed effectively and that audit trails are maintained.
The tools necessary to efficiently and effectively manage the creation, storage and use of translations. Companies use everything from simple documents through to complex and sophisticated translation management solutions in this area.
The tools necessary to ensure that what the user is looking at is a true representation of the underlying document. This includes such things as pdf creation, printing, electronic image presentation and colour management.
Collaborative Review & Approval
The tools necessary to allow individuals and groups to review individual documents, create and manage comments and ultimately securely approve documents. This area would include such things as electronic signature management.
Tools that help users to proof read documents and their associated elements such as barcodes and Braille. Whilst very useful in reducing errors in artwork, it should be remembered that these tools are only aids to skilled proof readers and need to be used with caution.
Change Control & Authorisation
The tools necessary to manage the definition and authorisation of changes in a compliant environment. The change control aspects of labelling and artwork changes will often be managed as part of a larger corporate change control system.
Bill of Material Management
Whilst often not considered part of the labelling and artwork suite of tools, bill of material management systems are key to the success of labelling and artwork management at either end of the process. Initially, they are key in ensuring an accurate and comprehensive impact assessment is carried out. At the end of the process, they are key to ensuring that the changed packaging components are implemented in a controlled way into production.
Planning and Work Management
Tools such as workflow technology that allow activities to be planned and routed to the right individuals at the right moment. More sophisticated versions of these tools will have the ability to manage large numbers of individuals, locations, work teams and separate organisations.
The tools necessary to gather and report performance information across the end-to-end capability. Some organisations will use corporate business intelligence tools for this.
Forecasting and Budgeting
The tools used to help forecast workload, plan resource capacity and financial budgets.
Don’t forget that many of these technology elements will need to be validated as the implication of their failure could impact artwork quality and therefore patient safety.
I will close with a word of caution when specifying, selecting and implementing technology which I have learned the hard way from experience. Many of the technology elements I have described have subtle interactions and dependencies with each other. Unless these dependencies are fully understood, it is very easy to make a change in one area that has an unforeseen and detrimental impact in another.