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Pharmaceutical Manufacturing and Packing Sourcer

Business Gain Without The Pain

Label lifecycle management (LLM) is a mission-critical system for global medical device manufacturers, though its place at the top table of corporate success factors has largely been achieved by stealth. In some organisations, LLM remains off the radar for the strategic executive, despite the significant operational gains it can help businesses to achieve.

As the pressure to increase efficiency and productivity intensifies, medical device manufacturers are understandably examining operations right across the supply chain to streamline processes, reduce costs and mitigate risk. Yet, with a sizeable percentage of medical device recalls caused by packaging defects, companies’ dogged persistence with dated, costly and inefficient labelling systems are both surprising and self-defeating. The question is: why is this the case? And, more importantly, how can old methodologies be transformed to drive progress, productivity and profitability?

Resistance to Progress

A primary reason for the widespread reluctance to change is that, in many organisations, no-one has clear ownership of, or accountability for, the labelling strategy. Although LLM is indeed mission-critical – if labels cannot be printed accurately, a product cannot ship and the inherent costs are huge – it is often an ‘orphaned’ critical business function. This approach is endemic across much of the sector.

A second and, perhaps, more significant factor in companies persevering with traditional labelling methodologies is the perceived headache of validating a new system. This is a legitimate and understandable concern that is rooted in companies’ historically painful and expensive validation experiences. However, as technology and best practice evolves, organisations cannot afford for past perceptions to create unnecessary barriers to progress – and prevent them benefiting from the operational gains that a more modern system can provide.

By adopting a pragmatic, risk-based approach to validation, medical device companies can transition from the burdensome and costly processes that plagued previous implementations to the deployment of a more nimble LLM infrastructure that can stimulate business growth. Moreover, by leveraging supplier expertise and maximising supplier innovation, organisations can develop a validation lifecycle that delivers operational gains quickly, efficiently and cost-effectively.

Why Validate?

Despite occasional conjecture that, as an integrated component of a wider printing system, a typical medical device labelling system does not need to be validated, regulatory framework emphatically states the contrary. The need for validation is enshrined in all major regulation in the US and EU – most notably by the FDA, whose adoption of Good Manufacturing Practice (GMP) regulations has subsequently been used as the basis for other regional and national legislation.

Software validation is a fundamental requirement of the FDA’s 1996 Quality System Regulation, 21 CFR Part 820. The regulation stipulates that “when computers or automated data processing systems are used as part of production or the quality system”, medical device manufacturers should “validate computer software for its intended use according to an established protocol”. The scope of the regulation extends beyond software components of medical devices themselves and into all aspects of production, manufacturing and supply chain processes. 21 CFR Part 820.70(i) defines this as: “Any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling or to automate any other aspect of the quality system.”

Intended Use

The regulator’s insistence that software should be validated “for its intended use” is critical. The phrase puts paid to any suggestions that a labelling system, for example, is a component part of a wider printing system and therefore exempt from validation requirements.

Moreover, intended use is itself a key part of the FDA’s definition of software validation. It classifies validation as: “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”. The requirement to produce objective evidence is fundamental to the regulation, and places the onus on manufacturers to ensure that processes and procedures are robustly documented throughout the label lifecycle.

Off-the-Shelf Software

When necessary validation information is not available from the vendor, the device manufacturer will need to perform sufficient system level ‘black box’ testing to establish that the software meets its “user needs and intended uses”. But for many applications, black box testing alone is not enough. Depending upon the risk of the device produced; the role of the off-the-shelf (OTS) software in the process; the ability to audit the vendor; and the sufficiency of vendor-supplied information, the use of OTS software or equipment may or may not be appropriate – especially if there are suitable alternatives available. The device manufacturer should also consider the implications for continued maintenance and support of the OTS software, should the vendor decide to terminate its support.

Electronic Records

In addition, criteria to regulate the use of electronic records – in particular, for electronic signatures and digitally archived handwritten signatures – have evolved considerably. FDA guidance 21 CFR Part 11.10(a) stipulates that computer systems which create, modify and maintain electronic records, as well as manage electronic signatures, are also subject to validation requirements. These programs must be validated “to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered records”. The regulation is designed to provide additional security, data integrity and validation requirements for automated record-keeping systems. Once again, EU regulations – laid out in EU GMP Volume 4, Annex 11 – mirror the FDA guidelines and place great emphasis on the importance of maintaining comprehensive audit trails across all electronic systems.

Electronic records and signatures play a prominent role in the labelling process and are at the heart of any efficient system in the modern marketplace. Processes and procedures ensuring validity and traceability across the global supply chain are therefore a prerequisite of any effective LLM solution.

Removing Old Labels

A leading-edge LLM system is often a relatively moderate investment that can yield significant added value. Historically, however, the cost of procuring a new system has been dwarfed by huge validation costs as companies become absorbed in unnecessarily bloated testing cycles that slow down implementation and increase overheads. Estimates suggest that validation can account for up to 25% of total project costs and extend implementation time by as much as 300% (1). It is perhaps no surprise that validation pain has led to a widespread culture of inertia, leaving businesses stranded on old technology while the market moves forward.

However, such labels have become outdated, and it is time for them to be peeled away and replaced with a new attitude. The Good Automated Manufacturing Practice 5 (GAMP 5) guidance, published by ISPE in 2008, outlined a framework for a Risk-based approach to compliant GxP computerised systems, which provides an antidote to traditional validation inefficiencies and a blueprint for medical device companies to harness the opportunity of contemporary innovation.

Leveraging Suppliers

GAMP 5 sets out five key concepts to help medical device companies reduce the escalating costs of validation: improving compliance while bringing greater efficiency to the process. These key concepts are:
  • Product and process understanding
  • Lifecycle approach within a quality management system
  • Scalable lifecycle activities
  • Science-based quality risk management
  • Leveraging supplier involvement 
The guide advises that regulated companies should “maximize supplier involvement throughout the system life cycle in order to leverage knowledge, experience and documentation, subject to satisfactory supplier investment”. It points out that suppliers could be well-placed to help with gathering requirements, risk assessments and creating functional specifications, as well as system configuration, testing, support and maintenance. Moreover, it outlines that through better planning and proactive engagement, companies can maximise supplier and test documentation to avoid wasted effort and unnecessary duplication.

The medical device industry is, of course, heavily regulated with the need to protect patient safety: the ultimate driver for regulatory compliance. As such, the industry’s historical commitment to thorough, robust and comprehensive validation cycles is both laudable and understandable.

However, GAMP 5 believes that many costly testing cycles are duplicated and “do little or nothing to protect the patient”. It therefore argues that through increased focus on patient risk and by leveraging suppliers’ expertise, validation and verification, it can – and should – be considered an integrated set of activities capable of replacing installation qualification (IQ) and operational qualification (OQ) protocol. In turn, regulated IQ and OQ activities may then be “omitted or limited to an assessment of the supplier’s activities and documentation” and, if necessary, companies can perform “mitigation activities” to close the gaps. This eliminates unnecessary and unproductive replication.

The guide concludes: “Finally, the overall performance and fitness for intended purpose can be ensured through performance qualification (PQ) or verification, which focus on critical-to-quality attributes. This will demonstrate that the equipment or system is performing satisfactorily for its intended purpose, the process with which it is involved is controlled, and the risks to the patient have been effectively managed” – thus meeting the regulatory requirement for validation.

Early Engagement

Trusted collaborative supplier partnerships may not only curb wastage, expedite processes and maximise operational efficiencies, but they can also make a significant contribution to driving organisational growth. This is particularly the case with labelling suppliers, with LLM touching every part of the supply chain process and reaching all corners of a global enterprise.

To optimise the opportunity – and leverage the capability and expertise within providers of turnkey labelling solutions – medical device companies should seek early and proactive engagement with potential labelling suppliers. Early engagement can help these suppliers identify and understand a firm’s wider business challenges and uncover potential areas where an LLM system may be able to deliver unexpected gains. In turn, it can help organisations to develop collaborative solutions that not only deliver against mandatory compliance requirements, but which also align with known business goals and strategies. Crucially, proactive, cross-functional engagement enables the considered and pragmatic planning that is necessary to develop an efficient, streamlined and cost-effective validation roadmap that delivers returns quickly and effectively.

Beyond the inherent risks to patient safety, the cost of sub-optimal labelling operations can be significant. On average, a single change costs as much as $500,000 for a large company. With few organisations giving ownership and accountability for labelling to key individuals within their business, many companies still overlook its strategic importance and underestimate its impact across the supply chain. This often culminates in a request for proposals that fails to optimise the full scope of LLM, focusing instead on addressing specific point-based problems rather than driving long-term business value.

The most successful companies have recognised the value of early engagement and frank disclosure with labelling solution providers, developing the strongest levels of partnership throughout the entire validation cycle. Moreover, while their overarching goal is to ensure that software is sufficiently tested to mitigate risk and protect against labelling errors, the most progressive companies have adopted a more pragmatic approach to validation. By discarding labour-intensive models built around countless duplicate and expensive testing cycles – and working collaboratively with trusted suppliers with specialist expertise in validated LLM systems – they have been able to deliver a more streamlined model that leverages efforts from prior cycles to minimise work downstream.

This collaborative, integrated and pragmatic approach is helping companies cut months off the traditional deployment and implementation of an enterprise-level system. In the process, the approach reduces costs, accelerates return on investment, and allows internal champions to benefit from deserved recognition of driving innovative change.

From Pain to Gain

With the advent of new disruptive technologies, the support of global regulations and guidelines, and the expertise of experienced, specialist labelling suppliers, the long-standing notion of ‘validation pain’ need no longer present a barrier to the introduction of LLM innovation. The most progressive medical device companies are recognising that with the right supplier and sustained collaborative engagement across their organisations, it is possible to deliver the appropriate balance of testing coverage, validation, control and process in a streamlined, efficient and cost-effective manner.

Validation pain is an old label that has come unstuck. With strong, trusted suppliers, partnerships and shared expertise, medical device companies can realise the true business value of LLM – and make the rewarding journey from validation pain to real business gain.

  1. ISPE, Risk-based validation – The benefits of the GAMP approach, 2012

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Dave Taylor joined PRISYM ID as Product Manager in 2006, and is now Vice President of Global Products. He manages the company’s product lifecycles and services on top of identifying, and researching, new applications and markets. His experience includes the deployment of identification and traceability solutions within multiple industries, including food, chemical, pharmaceutical, aerospace and automotive, as well as general manufacturing and logistics. Previously, Dave worked for Star Technology as Sales Operations Director, where he was responsible for all technical pre-sales and product support. He has also worked for Navisite, a US Managed Services company, as Operations Director, and AAH Meditel, a primary care software provider.
Dave Taylor
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