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Software automates the labeling process, ensures compliance with regulations, prevents errors, and cuts costs.
The globalization of pharmaceutical products, a constant flow of regulations from 150 regulatory bodies worldwide, and increased demand for quality and compliance are prompting pharmaceutical companies to consider deploying a label management system (LMS). Such systems can integrate with enterprise resource planning systems and automate the label management process, replacing manual procedures.
Compliance is a major driving force in the adoption of an LMS, along with eliminating errors, shrinking time to market, and cutting costs. “There has been increasing regulatory focus on labeling, in recognition of the important role labels play in patient-centricity and the need for accurate labeling to ensure patient safety,” reports Simon Jones, vice-president Global Product at Prisym ID.
Orchestrating labeling processes “optimizes time and resources, mitigates risks, and sets course for [a] competitive edge,” adds Julian Backhouse, associate director of Regulatory Technology at IQVIA. “Fragmented information, disparate processes, and lack of collaboration are no longer acceptable or viable,” adds Cham Williams, associate director of Business Systems at IQVIA.
Digitalization gains importance in the COVID era when many staff members are working remotely. “Being able to approve and review labeling digitally makes ensuring compliance a much more simple and fluid process,” said Wendy Payne, senior product manager, Loftware (1).
When selecting an LMS, suppliers agree life sciences experience is essential so there is an understanding of regulatory compliance demands, such as GxP and FDA requirements. “The supplier should understand forthcoming changes in … regulations, such as the EU’s [European Union’s] Clinical Trial Regulations and Falsified Medicine Directive, emerging market trends including e-labels, electronic instructions for use, [and] the new GS1 Clinical Trials barcode standard,” says Jones.
He continues, “The best systems have life science best practices integrated into the software, such as the ability to mandate label watermarks and supervisory sign-off. These should be highly configurable, but also provided with defaults set representing how pharma and medical device customers typically use them.” Other important features include the ability to confirm label designs are compliant with regulations, compatibility with character-level vision inspection systems to ensure print accuracy, and functionality for electronic records and electronic signatures.
An LMS should be able to provide alerts to label changes in real-time and automate execution. IQVIA’s Williams reports, “Technological advances such as artificial intelligence, machine learning, and natural language processing are paving the way for automation-enabled label management solutions. Regulatory intelligence arms life science professionals with real-time notifications indicating where, when, and how labels need to be changed. Core change control capabilities help teams optimize execution workflows including authoring, content management, and activity planning and tracking capabilities. Additionally, organization-wide consistency is a must-have. An ideal label management solution will enable real-time data integration and data-sharing with, for, and from the various … stakeholders who contribute to the label management process.”
Jones adds, “GAMP V [good automated manufacturing practice from the International Society for Pharmaceutical Engineering] emphasizes that suppliers should assist in validating the system. Suppliers without expertise in pharma-regulated labeling are unlikely to be able to provide the … objective evidence-based test results, or IQs/OQs [installation and operational qualifications], increasing the effort required to validate a system and the associated compliance risk.” Costs are likely to be greater too. “The cost of validating general enterprise labeling software to make it fit for use in an FDA-regulated environment can easily equal the price of the software itself,” he explains.
As a result, prevalidated, Cloud-based platforms and browser-based apps are becoming the preferred option for many organizations. “Implementing a Cloud-based system typically requires less personnel time and hardware,” reports Mari Waldron, product and enterprise marketing director at NiceLabel. “There is no need for servers, for example, nor the need to update software, as this is all done for you,” she adds.
As one example, Boehringer Ingelheim implemented a Cloud-based LMS from NiceLabel at production sites in Ingelheim, Germany, and Sant Cugat, Spain, and the company continues to roll out the LMS to other production sites as well as locations devoted to warehousing and quality management (2). NiceLabel reports that Boehringer Ingelheim now uses label templates in the label design tool rather than multiple legacy systems. Document management functionality replaced manual quality control procedures and provides security, approval workflows, and label change and print history. Integration between the LMS and ERP centralizes updating of label information, provides a single source of label data, and reduces labeling errors. NiceLabel serves as the printing tool and the company’s enterprise resource planning system serves as the printing trigger (3).
The biggest pitfalls in the implementation of an LMS include under-estimating the amount of time, attention, and planning needed to implement change management; lacking a clear objective; taking a siloed or department-centric approach; and failing to recognize the role people play. “People are a crucial success factor,” says Williams of IQVIA.
Successful implementation requires continuous change management, content management, and scalable technology that includes internal and external stakeholders. Williams says, “To effectively accomplish this, companies must lead with top-down support and champion system implementation while also securing stakeholder buy-in, managing expectations, … and paving the way for alignment on future-state updates. All the while, there must be checkpoints for knowledge transfer and purpose-built development and upgrades.”
Stakeholders include clinical, quality, regulatory affairs, safety, manufacturing, legal, marketing, and artwork department personnel, as well as local entities, information technology architects, and system owners. “This [wide range of stakeholders] is a major factor in why the orchestration of label management holds so much promise—it enables the streamlining of information between many disparate parties,” explains Williams.
When planning the rollout of an LMS, Waldron recommends hiring professional services support. She concludes, “The specialists can advise on best practices, help to scope the project thoroughly, and get the new system deployed fast. Trying to do it on your own … leads to lengthy projects and … [failure] to follow best practice.”