Martin Linch examines what pharmaceutical companies should be looking for in an ERP system
According to some, the global pharmaceutical industry is facing some of its biggest challenges to date. The combination of worldwide price pressures and unstable economies in countries such as Brazil, China and Russia, has led to a slow-down in the sector (with these three accounting for 50% of global pharmaceutical revenues). Add to this the fact that many governments have tightened their healthcare budgets considerably post-global economic crisis, and you can see why these are challenging times indeed for many pharmaceutical companies operating in this fast changing digital era.
The long product development cycles that are par for the course can make it tough for pharma industries to keep pace with a rapidly changing business environment. This is especially true when the anticipated push towards the development of personalised medicines is coinciding with potential reductions in R&D spend in response to pricing pressure. In these testing times, for pharma businesses to maintain that all important competitive edge, it’s vital that they have the ability to focus on product development and capitalise on opportunities, while remaining agile enough to respond effectively to market dynamics.
To achieve this, technology is key, with the right system affording the necessary levels of business insight, facilitating best operational practice and providing the foresight necessary to stay competitive and in control. Such are the nuances and distinct needs of the pharma industry, what’s needed is a solution which addresses pharma-specific issues, rather than an off-the-shelf, one-size-fits-all system. Plus, to increase the solution’s effectiveness further still, the right partner can help choose the right solution to meet the particular needs of your business.
A good starting point is to identify what you should be looking for in a system. So, what are the must-have features for a pharma industry solution? The ten tech commandments for pharma businesses if they are to thrive in what is potentially the most regulated industry in the world?
- Regulatory compliance, both national and international, is a must. The solution must provide a comprehensive and complete audit trail, supporting Food and Drug Administration validation and Sarbanes-Oxley compliance, fulfilling MHRA requirements and demonstrating full transparency in production and distribution of pharma products. In-built forms and pre-defined workflows can help simplify the web of compliance processes too.
- Traceability is vital, as all pharma businesses know all too well. The right system provides the easy-to-use capability to track multiple levels of each lot of raw materials (backwards and forwards in the supply chain), enabling both quick and efficient recalls.
- Inventory optimisation is another must-have. FIFO or LIFO processes are inadequate so you need to ensure your chosen solution operates in line with the principle of FEFO, to not only ensure safe and effective products, but to also eliminate waste and reduce inventory costs.
- Formula management should be built-in, allowing for the scalability of formulas and providing the granular level of detail required to adjust them, with any changes automatically communicated to inventory, production and planning. A full audit trail of revisions should be possible, documenting batch recipes, the technical composition of various ingredients and the manufacturing process.
- Batch data control can map all associated traceability transactions in order to better understand and better react to a recall. This is key to reducing stock write-offs, with the right system providing greater control and regulation of shelf life and expiry dates, increasing efficiency and mitigating against product recalls.
- Complaint management, with regard to product quality, must be fully integrated into your ERP system. To save any errors or miscommunications, complaints shouldn’t be stored away for customer service to deal with. They can have an impact on financials, quality processes and future product development/strategy and should be fully integrated to optimise operational performance.
- Scheduling for pharma businesses can be a minefield. The right system can manage the scheduling of the inevitable multi-faceted business processes, optimising efficiency without disrupting or delaying production, keeping customers happy and ensuring safe production.
- Labelling accuracy means everything in the world of pharmaceuticals. Not only will the right system calculate vital ingredient data, but it ensures that all reports and documents relating to the data and subsequent certifications are stored in one location, readily accessible by all.
- Certificate of analysis capability should come as standard with the right pharma solution. This provides the flexibility to handle a wide range of official documents such as MSDSs and COAs quickly and easily, with the capability to print, on demand, general or customer-specific certificates to provide those all-important product assurances.
- Quality control requirements are inevitably stringent for the pharma industry. The best solutions can handle all necessary quality requirements, including FDA, GxP and ISO, to name but three. The ability to validate all quality control results with an e-signature is a must, as well as the capability to store the results in an easy-to-search repository.
Find out more about how the right solution can help your pharmaceutical business grow.