At Columbus, we’re driven by our passion to make businesses succeed in the digital age. And so, we place a very high premium on constantly upgrading our knowledge and skills. This blog is an updation of a previous one, and has been written in keeping with the ‘continuous learning culture’ we have at Columbus.
Life sciences – The industry that never sleeps
Life sciences companies – such as yourself – are aware of the benefits a cloud-based ERP solution delivers in achieving (sometimes overachieving) business goals despite evolving regulations and complex business process changes.
However, there is always the scope to re-evaluate what we know and instead, learn about the fresh developments in a dynamic industry like life sciences. After all, companies in this space are continuously ‘evolving’ even as they go through the product lifecycle – from the pre-clinical, to the approval, to the go-to-market phase. To quote a leading US-based SAP Gold Partner, "A life sciences business doesn’t just grow; it changes as the business unfolds."
Each phase has its unique requirements, tasks and challenges that need to be addressed. An ERP solution capable of managing the variables and the complexities of each phase is the one that can realize long-term growth. The question is – How do you ensure you have selected such an ERP solution
How to select the right life sciences-specific ERP solution?
Having a checklist ready, and abiding by it, works like a charm while making correct decisions. Selecting the right life sciences-specific ERP solution will be easy for you if the solution (you are considering) meets these six criteria:
- Scalability – If the ERP solution allows you start small but can scale up in terms of (its) utilization and operational complexity, then you have a winner. The right solution allows you to scale easily without replacing your existing system in order to accommodate your growth.
- Serial and Lot (Number) Traceability – Product recalls are a nightmare for any life sciences company. However, if they do happen, the ERP solution must be able to quickly and accurately trace and track each such product/ product component’s location (whether it is in stock, in the finished form, or at the customer’s site). In other words, the correct ERP solution should be able to assign a serial number and a lot number to products as well as product components to carry out the trace-and-track function smoothly. Such an ERP solution should also be able to gauge product quality to facilitate improvements to them.
- Regulations compliant – The correct ERP solution must be able to help you meet FDA (including Corrective and Preventive Actions [CAPA]), Good Manufacturing Practice (GMP) and other local compliance requirements around product quality, manufacturing security, manufacturing plant maintenance, audit trails, and overall Good Informatics Practices.
It must also help you prove – quickly and cost effectively – to the FDA that the necessary controls are in place (at your end) to handle and track operations the way the FDA needs them to be. A pre-packaged ERP solution (instead of a custom installation) can get implemented faster, introduce best practices across processes, lower risks, and reduce third-party validation cost for FDA compliance.
- Electronic Signatures – The right ERP solution will have built-in electronic signature capabilities and the ability to customize them because every employee on the plant floor must have a unique and readable electronic signature (to meet the FDA requirement of 21 Code of Federal Regulations part 11). These signatures can either be controlled biometrically or through two forms of validation (a password and a user code) and must be specific, identifiable and capable of verifiable signoffs to ensure the highest levels of safety and security.
- Real-time visibility across functions and access to information – Like I’ve mentioned earlier in the blog, life sciences companies continuously evolve; even as they go through the product lifecycle. Given the rapid pace of this change, detecting issues and adjusting operations suitably is critical and ongoing and needs real-time visibility into supplier and operational data. The right ERP solution will give a full picture of your business’ current status, with analytics and reporting prompting you to make the necessary adjustments.
- Quality and Cost Management – A life sciences industry-specific ERP solution must be far more sophisticated than other ERPs because companies in this space need in-depth quality assurance (and management). The correct solution must, therefore, have a built-in full-feature quality management functionality.
The creation, manufacturing, launch and distribution of a new drug/ device requires significant funding. The right ERP solution must give you real-time visibility into material costs and other variable spends, besides monitoring vendor pricing. It must also flag cost exceptions and suggest tools that can help you structure alternative sourcing prospects.
- Customization and Commercialization support – A life sciences-specific ERP solution must be flexible to handle changing business processes and regulations among several other variable business elements. Especially since changes can occur at any time and are not restricted to only when the implementation starts.
Equally important is the ERP solution being able to quickly ramp up manufacturing, production, the supply chain, sales and fulfilment before the product goes to market (on a commercial scale). The right solution can even recommend commercialization-related best practices such as manufacturing/ integration with a manufacturer, 3PL integration, product planning and quality management.
The above is a sample list of the key features a life sciences ERP solution should ideally have; characteristics that are top-of-the-list for life sciences companies. At Columbus, we specialize in providing digital transformation advisory and services to life sciences companies at every stage of the product lifecycle. We perform business assessments and evaluate specific areas like commercialization planning, financial reporting and regulatory compliance too. To learn more, write to us at us-marketing@columbusglobal.com.