Labeling Regulations/Exceptions during Covid!
Several global regulatory and health agencies issued guidance with regards to the conduct of clinical trials during the COVID-19 pandemic. This swift action taken by the regulatory agencies was in direct response to global concerns around assuring the safety of clinical trial participants, maintaining compliance with GCP and minimizing risks to trial integrity during this unprecedented time.
ZERO Guidance or Regulations given by any agency for Labeling exceptions. That means whether your regional teams are disrupted because of Covid, teams cannot follow-up labeling changes on time or people doing WFH, or other changes, your labeling obligations remain SAME, if not increased more
Label compliance may not be high priority for your compliance teams or health authorities or some of you as there are other priorities. When dust settles, some of your Labeling gaps might pose major challenges and companies will have to incur extra costs to bring any label non-compliance to order. From studies in the past, for a business, the consequences are costly, with the average label change sitting at $350,000.
In addition, the risk of non-compliance is significant. From the potential regulatory fines and loss of brand reputation, temporary forced shutdown of a full production line and cost of re-mediating, not having a validated system and process in place could have a potentially catastrophic impact on business.
Labeling Digitization to Rescue
Digitization & Automation offers traceability that not only mitigates potential risks but also drastically improving labeling efficiency.
For existing labels, with the help of inbuilt translation engine, reverse translations can be done on existing regional/country labels and compared to either CCDS, USPI or SmPC. This will help identify existing gaps / violations faster without having to execute “special” compliance projects saving cost an reducing pain for the teams (as labeling teams don’t enjoy doing these tasks anyways)
For future labels, technology will help in achieving a comprehensive view of labeling operations and touch points in relation to the rest of the organization minimizing your attempts to resolve any issues in isolation. With Label Content digitization, changes and life cycle can be managed holistically, rather than managing with out-dated process of managing labels/documents following painful processes of maintaining versions, copies, track modes etc.
With the ever changing landscape of labeling technology, there are now solutions on offer fit for every type of organization at all budget ranges giving modular options. Yet, for many who get satisfied with an EDMS, the implementation of these newer tools/technologies is still accompanied with apprehension (for some lack of time and for others control issues). These automated solutions can end the recurring insanity of labeling challenges. Digitization & Automation will help future proofing operations within the overall labeling supply chain.