How is your company managing risks related to packaging artwork development?
Let’s start with a case study. A mid-sized pharmaceutical company, engaged in packaging artwork management and artwork studio services, did not deploy artwork proofreading system at the artwork studio level, though it had an electronic proofreading system in review and approval stage for the Regulatory Affairs (RA) team. Due to this structure, the approval process to finalize an artwork was long and tedious. Any error introduced by the artwork studio was picked at the review and approval stage, further adding time to the artwork approval process and increasing the number of versions.
The solution: Deploying Quality Control Analysts during the proofreading
As part of the artwork management services and process improvement initiatives, a detailed study was done on the process. To improve timelines and people competencies, electronic artwork proofreading systems were deployed at the artwork studio, along with recruitment of Quality Control Analysts (QCA). Every artwork created inside the artwork studio was proofread by the QC team with the help of the electronic tool and any error was quickly addressed by the artwork operators before it reached the RA team for review and approval. This additional process step helped in improving quality and reduced timelines to market. In the process, auditing requirements were also kept in the purview. Version control was taken care of with each loop from QC person to artwork operator.
Role of Quality Control Analysts
Quality Control Analysts are also known as artwork proofreaders in some pharmaceutical and life sciences companies. They play a pivotal role in ensuring that packaging artworks are created as per the labeling documents available and approved as per related health authority requirements. Not only text, they make sure all the technical components such as dimensions, barcodes, braille, and colors are perfect in terms of artworks and printing.
There are several off the shelf tools/artwork inspection tools available in the market for the purpose of electronic proofreading of packaging artworks. Some of these include: Global Vision, TVT by Schlafender Hase, Informa IT, and EyeC Inspection.
Wipro’s approach to proofreading and quality control
Integrated with a 360-degree perspective on artwork lifecycle management, right from core labeling text to packaging artwork design to printed packaging material, Wipro offers its clients an effective proofreading/QC system that checks for quality defects across the pipeline.
The proofreading/QC checks within the artwork quality management include:
Wipro’s proofreading/QC approaches:
Once the artwork operator completes the creation of the artwork, the next process step is to do proofreading/QC of artwork created. This should be end-to-end proofreading of packaging artwork and labeling documents with the help of industry standard electronic proofreading tools for technical and text checks which may involve manual proofreading in some cases for elaborate quality check of artwork created. Activities that are required to be performed at proofreading stage may include:
Other activities include:
Quality assurance with artwork management is critical and its proper usage in each workflow step is vital for the success of the process. Not only does it save cost but also improves the process and functioning of the related supply chain. This allows faster production and time to market.
Pranab’s experience spans over 21 years across Labeling Artwork Lifecycle Management in the pharmaceutical and life sciences industries regulatory domain. He has worked for major life sciences consulting firms and has catered to customers such as Novartis, GSK, and Apotex as a regulatory SME. He has also successfully transitioned pharmaceutical regulatory processes and projects, implemented related technology and established quality management including audit preparedness and SOP writing.