Take labelling for example. A merger can result in decentralised labelling processes with inherited home-grown systems and a new array of third-party suppliers, contract manufacturers, repackagers and relabellers.
It can also lead to expansion into new geographic markets — each with their own country specific labelling requirements.
As growing pharmaceutical manufacturers work to address these challenges, the importance of label accuracy can’t be understated.
A decentralised approach to labelling makes achieving label accuracy and consistency a complex task that can be a major threat to profitability, drag down efficiency, reduce agility and impact speed-to-market.
It can take weeks or months to bring new labels from design to approval and through to print. And when it comes to labelling outside the organisation, each supplier may have its own IT infrastructure and printers, further complicating the process.
Dispatching a label compliance mandate to 10 different suppliers is likely to result in 10 different labels being received. This is not a trivial matter. Regulatory requirements for accuracy are increasingly stringent, with severe penalties for any company that fails to meet them.
Penalties aside, it is estimated that half of all product recalls are caused by labelling or packaging artwork errors, with the average cost of distributing a recall notice standing at $8 million.
McKinsey, the global management consultancy, calculates that pharmaceutical product recalls occur as often as 20 times per week in the US alone.
The key to overcome these significant challenges lies in consistent, standardised labelling in the cloud. Cloud technology makes it possible for organisations to store their label information centrally, control the entire label management process and extend that standardised label process across the organisation and to suppliers through a secure, web-based interface.
As all parties are accessing the same information from the cloud as opposed to their own systems, the supplier’s printer brand or business systems won’t jeopardise the entire process. It is also more secure and much easier in terms of access.
IT personnel don’t have to devote time to checking credentials and granting access to the company’s internal labelling infrastructure.
Accessing information from the cloud also adds a layer of protection to internal systems, data and IP. This makes it much easier to onboard new suppliers who can quickly take advantage of the cloud’s anytime/anywhere access wherever they are on the planet.
Yet, before moving to the cloud for their labelling, pharmaceutical companies should begin by upgrading and overhauling their label processes. Many companies use separate templates for complex labels — either creating them on software not built for purpose or using IT staff to hard code label designs and changes.
To save time and increase consistency, label design should be simplified with a system that empowers business users or IT to design and change labels quickly, thereby reducing the dependency on IT and coding.
Label storage needs to be centralised so users can access the entire library from a single interface, locating and comparing labels across all operational locations. Searches based on label names or content will deliver fast results.
Modern label management systems will further increase efficiency by selecting the correct label according to predefined business rules. With such a system in place, third-parties using web access know they are looking at the most current labels and no longer have to jump through hoops before they can start printing.
Quality assurance workflows, which take up so much time, also need to be digitised with role-based levels of access, approval workflows and print history for audit trails.
To reduce label errors and mislabelling, a label management system that fully integrates with PLM, ERP, MES and WMS should be in place. Label layout needs to be decoupled from the production line, avoiding downtime for verification.
Shifting labelling to the cloud helps companies to overcome these challenges. In fact, many biotechnology companies have deployed cloud labelling to start extending activities to contract manufacturers.
Whereas the inability to see a contractor’s labelling software would have previously been a block, a cloud-based approach renders these difficulties almost irrelevant. A standard label template can be shared with all third-parties, wherever they are, whereas digitised quality control provides reassurance of accuracy and consistency.
The case for moving to a cloud-based approach is clearly irrefutable, offering major gains in accuracy, consistency, compliance and efficiency. It is also an approach that is in step with the future.
Data is proliferating exponentially in every sphere of business and the success of many companies will depend on how well they consolidate, analyse and share it — internally and externally.
Harnessing the power of the cloud will certainly help to future-proof label management and compliance for pharmaceutical companies.
