The pharmaceutical industry contains complex processes that could prove challenging to manage. A company in that field may find it significantly easier to do that with the help of an ERP designed specifically for pharmaceutical and life sciences companies. Inevitably, such ERP solutions should cover the majority of the processes, but it’s important to look out for some specifics. Let’s see what those are.
The solution is in compliance with mandatory regulatory requirements
Keeping a paper trail of documents for your procedures and processes could be risky. It’s important that the solution you choose provides you with easy access to the latest revision of any document you might need during your production process. This will help you perform plant maintenance correctly and let you prevent issues according to CAPA or GMP regulations. Furthermore, the solution you choose should follow FDA requirements or any local guidelines depending on your company’s scope. The best way for your company to easily achieve regulatory compliance is through automation of the validation process.
A higher level of safety and security with e-signatures
Approval and validation in pharmaceutical plants aren’t just a regulatory requirement, but an important way to ensure that every part of the supply chain is running smoothly and carefully. Beside being readable and unique, the electronic signature of each employee who may need one needs to be controlled biometrically or with two forms of validation: a password and a user code. Make sure you confirm that the ERP you’re looking for has built-in electronic signature capabilities, as well as an ability to customize them.
A partner who understands the intricacies of the industry
Though this applies to every industry, it is especially the case in pharmaceutical and life sciences: a partner that understands the complexities of the business is one who can create and support an ERP for this specific industry. So make sure you look for someone who has a solid background in pharma and life sciences ERP solutions.
The solution has a rigorous quality management mechanism
Pharmaceutical and life sciences ERPs are no regular ERPs. And most of their capabilities are a lot more sophisticated than other industry-specific ERPs may offer. As the needs of companies in the field require this, quality management and quality assurance in this type of ERP are very in-depth. Be sure to look for a solution that has a built-in full feature quality management functionality.
The ERP is subject to customization
Though a lot of the capabilities of a pharmaceutical and life sciences ERP should be already built in, it’s important that the solution is flexible. Regulations change, business process change, and so should your ERP. Look for a company that offers customization that would suit the exact needs of your company and can make changes at any time, not just in the beginning of the implementation.
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