COO, Global Software Division, Perigord Data
Risk in the Life Sciences industry is inevitable.
It’s not a matter of if your company is going to manage it, it’s a matter of how, and more importantly, how well. This is especially important for small and emerging organisations where any competitive edge could be the difference between hitting quarterly or annual targets or suffering severe financial consequences.
In terms of potential risk, the packaging and labelling process is one of the most vulnerable elements of a product’s life cycle. The risks, ranging from incorrect or incomplete product information to translation errors or incorrect specifications and versions being used, all share the human element as the consistent point of failure.
Any of these issues can lead to a regulatory breach, a delay in getting a product to market, a recall, or even a critical consequence for the patient. And while the packaging process is designed to identify, eliminate, and correct any potential issues, it is itself subject to the law of unintended consequences, meaning the process itself could cause new defects to be created.
Despite this, there are methods of managing and mitigating the risk. Methods that can turn a vulnerability into a company-defining strength. These strategies look at five key areas of the packaging process where risk can be managed or mitigated to maximise efficiency and potentially give companies a much-needed edge: the process, compliance, speed, quality, and the human element.
The less transparency there is in a process and the poorer the communication of information – be it a change requirement or some sort of supporting information – the more likely an artwork will have to go through multiple change cycles.
The basic arithmetic of risk assessment – risk = probability x potential loss – is the prime directive here. More cycles mean more touches; and more touches means an ever-rising risk of new and unintended defects being introduced.
This is particularly prevalent in manual or paper-based systems, or processes managed through ad hoc Franken-systems of interconnected excel sheets, an overload of emails, and unconnected apps. Systematic errors are tough to track, and data that could reveal valuable insights about the company and its individual products is often squandered.
“With the advent of Pharma 4.0 and the evolution of the digitisation of the supply chain, it is vital that companies first create optimised process flows before automating them,“ said Suzanne Ivory, COO, Global Software Division, at Perigord.
“Having a firm grasp of your artwork processes is vital for any organisation. Particularly one looking to scale up. Employing an artwork management system (AMS) is an excellent way to turn this situation around.”
“Mapping your packaging process for an online platform like GLAMS Q, allows organisations to establish a definitive model of their workflows. In doing so pain points, bottlenecks or unnecessary tasks can be removed, and your digital servicer becomes a real value creator for your business.”
As well as the overall process management, an AMS allows restrictions to be put on the data entered into it, significantly reducing the risk of incorrect or incomplete data, documents or specifications being used to complete an artwork. Users can also track artworks on a task-by-task basis, and take a deep dive into any of the data the system records to start building future strategies.
Meanwhile, implementing a suite of built-in proofing tools means every user that needs them can perform as many checks as they need to ensure artwork is right-first-time and the need for repeated review cycles is eliminated. Fewer cycles means fewer touches. Fewer touches means a more efficient system and less risk all round.
Labelling compliance is probably the biggest concern for Life Science companies of any size. However, for small and medium-sized enterprises, the margin for error is razor thin with no time in schedules or budgets for delays, recalls or financial penalties.
Whether it’s keeping up with updates to local or regional regulations, or adapting to the requirements of a new market, managing complex regulatory requirements with the business needs of efficiency and cost-effectiveness can be a headache.
“New and changing regulations in Life Science industries show no sign of slowing down,” explained Ms Ivory.
“Serialisations, IDMP and PV Management all increase the complexity of the packaging supply chain requiring a flexible approach to automation. Any system a company chooses to implement must be able to quickly adapt in a validated way.”
By using an AMS and managing your data and input requirements centrally, the stress and difficulty of implementing new regulations can be significantly reduced. GLAMS Q allows users to map countries and regions to regulatory requirements, ensuring all the process stakeholders are aligned in terms of their responsibilities.
The pressure to get your product to market as quickly as possible to maximise revenues is ever-present. Even before an artwork change has been assigned, implemented and approved, the clock is ticking. Every day that passes without the product on the shelves means losses for the company. So, like a sprinter sticking their head out as they approach the finish line, Life Science companies should be looking for any sliver of advantage to beat their competitors.
When managed correctly, a print at risk process can provide that advantage.
Combining a properly defined and implemented process with a realistic attitude to risk, printing at risk allows an artwork, SKU or entire campaign to continue to progress through its workflow despite any external dependencies.
So, instead of waiting on health authority approval before starting an artwork process, printing at risk allows the artwork to be initiated, created, checked and sent to print meaning that by the time the approval does come through the carton, leaflet or label is ready to go, not ready to start.
But working under huge pressure and tight deadlines is when mistakes are more likely to happen and printing at risk requires the level of transparency, integrated communication, process security and component traceability that can only be provided by an AMS.
GLAMS Q can help its users stay ahead of competitors and hit the shelves as soon as an artwork is approved, not in the days, weeks or months after approval. By allowing users to be assigned rights, privileges, and powers so that specific actions in the system – like changing a component status from “At Risk” to “Not At Risk” – can only be taken by specific users under pre-defined circumstances, GLAMS Q allows processes based on calculated risks to be carried out in a controlled fashion.
This means the overall risk of the process is mitigated and a clear and objective, data-decision can be made on any given scenario.
Sometimes errors do not necessitate a recall, but they are still quality defects. Even though you don’t have to start a recall, there can be potential quality control issues throughout the artwork process, and each of them have to be taken seriously.
While the cause of a defect may lie elsewhere along the supply chain, the buck stops with the company with its name on the box. The problem of maintaining an efficient and dynamic supply stream is needed to manage multiple versions or revisions of the same artwork element simultaneously.
It is the responsibility of the emerging and small pharma business to know where their packaging assets are and what is happening with them at all times. Having full visibility of all artwork asset insulates companies from the risk of an obsolete or archived version of an artwork accidentally being printed, and allows greater opportunities for leveraging previously approved artwork to shave valuable days and weeks off a move into a new territory or the launch of a new product.
“Optimised processes start with control. And for packaging, that control starts with the artwork,” explained Perigord’s Global Software Division COO.
“How, where, and who has access to the artwork at any time. What sort of access do they have? Having credible, consistent answers to these questions is of paramount importance to mitigating risk. Too often, however, this lack of control is at the heart of packing recalls.”
By applying a unique ID to every entity within the system and an automatic version number to its artworks, GLAMS Q makes sure there is no confusion about which revision of an artwork is approved or not, and which one is the latest version.
Similarly, by separating the in progress artworks from the approved and automatically archiving superseded versions, the risk of the wrong artwork being used in the system is reduced and users gain the ability to quickly and easily meet any audit requirements they may encounter.
Finally, by allowing users to link centrally managed assets like keylines, pictograms or barcodes, the risk and effort of making sure the right supporting document is available is severely reduced.
With human error at the heart of many of these issues in the Life Sciences packaging process, it is clear that the most effective way to improve your company’s market position is making a move to an artwork management system that can help automate parts of the process and implement controls on users to mitigate the risks of incorrect specs, incomplete data or non-compliant artwork going to print or, even worse, hitting the shelves.
This is all the more important for emerging and small pharma businesses which place a premium on agility, efficiency and economy, squeezing the most value out of every available asset.
Reducing risk where possible, mitigating it where practical and leveraging it when called for can be the key to giving an organisation a vital competitive advantage and driving it forward to future success.
GLAMS Q, the latest AMS release from Perigord, offers an essential platform, perfect for a small Life Sciences company looking to move from a paper-based system to a digital service or an emerging organisation looking to leverage both its data and its risk to move to the next level.
Join us on Thursday, December 6th, 2018 for a live 45-minute webinar on how to optimize your labeling and artwork process with ease. Sam Cole, an experienced life science professional, will outline the challenges faced by emerging and small pharma companies, and how to overcome them by using an artwork management system. The number of seats is limited.