Validation of enterprise data systems should be planned for and executed correctly. Consultants with specific industry and system expertise can help. Any QMS, LMS, or MES functions that deal with consumer product data in FDA-regulated industries are required to be validated in accordance with current GxP guidance.
MES software is becoming more complex, with connectivity, flexibility, and functionality that increasingly subject them to regulatory scrutiny. Validating the MES and interfacing it with the LIMS, ELN, or ERP gives organizations competitive advantages in terms of quality, compliance, new market opportunities, and reporting. Complementing your LIMS or ELN with an interfaced and validated MES solution will allow you to see the maximum benefit from each system.
Validating your QMS or LMS will provide the necessary level of compliance expected by regulatory agencies. Your quality organization plays an important role in ensuring the integrity of your product. A robust training ecosystem supports your regulatory compliance at each step of the production process.
Engaging with CSols for these types of validations will ensure that only the necessary functions are tested to verify that the system is fit for its intended purpose.
Another important step in regulatory compliance can be achieved with validation testing of your instruments. This is a necessary but time-consuming process. Contracting with CSols to oversee this work for your organization can free up your staff and let them focus on their science.