Traceability is the greatest continuing challenge for managing global pharmaceutical labelling. Many companies are still dealing with fragmented and outdated systems, as well as manual trackers, which makes tracing, updating, and reusing labelling content very difficult.
Managing the Chain of Relationships
In order to move beyond this, the ability to easily manage the relationships between core data sheets, labels, translations, supporting documents, and even parts of documents etc. is essential. If we imagine a chain of relationships between these documents, we are able to manage changes instantly and globally between our labels (including their local translations). This then helps us react quickly to variations and local approvals or positive opinions. In this scenario, the system needs to support simple and automatic relationship management between our entire chain.
The complexity of this matter is driven by a few different factors: firstly, a variety of documents are involved in labelling and require differing automated business processes; along with core data sheets there are also individual labels for different dosage forms, strengths and varieties. To make matters worse, these are then often modified at a local level, following a different process and using a different system. Unless you have the ability to relate these documents or parts of documents back upstream, your organisation cannot react efficiently to positive opinions or approvals. This requires an organised and systematic approach to ensure each document is dealt with correctly.
What’s What Where?
One particularly difficult process is reconciling multiple versions of a label. If you use a labelling system today, there’s a good chance that you’re using branch versioning for this. However, branch versioning can become incredibly non-user-friendly; how do I know whether I should look to version 1.2.13 or version 1.1.19 of a label and what does this really mean? Largely this is a hangover from pure content management systems that are not designed to manage the specifics of parallel activities such as labelling.
Instead, we should focus on what’s important to know – mainly:
- Has this document, or part of this document, received a positive opinion or approval?
- Were there specific changes made to this version in order to achieve that?
A modern labelling solution can use automated relationships, strong component-based authoring, and contextual metadata linked to your global and local submissions, allowing you to easily answer these questions and move forward with an updated master label.
Dealing with Change
Regulations in the pharmaceutical industry also vary, meaning that labels have to be updated and changed, starting the process all over again. For some businesses it can take years to have everything properly sorted.
Maintaining multiple systems and trackers, especially across different markets, can be very risky. If you are unable to track variations and new requirements back to a global level, you are unable to avoid repeatedly falling foul of regulators in multiple markets. Not only is your reputation at stake, but also the safety of your patients and customers. Having separate, manually driven processes increases the scope for error, as opposed to one, automated system which centralises and prioritises these changes.
Despite the risks, many companies continue to manage labelling with decentralised tools and processes. Automation can have huge benefits for things like re-use of complaint wording, symbols, and other criteria that require rigorous verification. A systematic centralised approach can also easily manage and create labels with approved templates and logos, ensuring consistent global quality.
CARA for Labelling
CARA has many different features which help make labelling more straightforward for its users. Here are some of the things you can manage using the CARA platform:
- Author components and Core Data Sheets
- Generate labels from both Word and PDFs
- Generate and trace translations via automated relationships and workflows
- Create and manage artwork and product packaging
- Publish submit, track health authority status
- Portal for affiliates and print shops
- Trigger and manage change requests (Safety, Reg Affairs etc)
- Update components based on ‘where used’ tracking
All of these features work together to make the process easier and less prone to costly and unnecessary mistakes. More and more Life Science companies are beginning to leverage automation and structured, component-based authoring not only in labelling, but across all functional areas. Finding the right information management solution early can help companies stay ahead of the curve.
If you are interested in finding out more you can register for our upcoming webinar “Labelling with CARA” below.