Botanical manufacturer enhances product documentation processes
Bio-Botanica has deployed a new system to manage its batch product manufacturing documentation and process flow. With the solution, M-Files QMS, Bio-Botanica can establish a single repository to handle product documentation more effectively and securely.
Bio-Botanica manufactures products for the cosmetic, personal care, pharmaceutical and nutraceutical industries. As a result, it manages considerable regulatory information, R&D documentation and specification data associated with each product.
Jason O’Neill, director of sales at Bio-Botanica, says, "We're audited by the FDA and other third-party entities, and with M-Files QMS, we can prove we're managing documentation and workflow processes according to defined standards. Our quality team is responsible for managing the full host of product documentation, all of which must be continuously controlled. With M-Files QMS, not only are we able to automate those procedures, but we also have the ability to manage precise versions and information control with metadata, ensuring that our team is utilizing accurate and up-to-date product information."
M-Files reports that the process is handled behind Bio-Botanica’s firewall to ensure only the most current information is available. The company set up permission controls and used the workflow capabilities in M-Files QMS to automate compliance-related processes to ensure only authorized individuals can access, edit and approve documents and other information. Bio-Botanica is also using M-Files QMS to develop a smoother, more transparent audit process.
M-Files QMS integrates seamlessly with Bio-Botanica’s existing enterprise resource planning (ERP) solution. O’Neill says, “We are able to easily configure M-Files QMS to model the exact batch production approach we were already utilizing within our ERP system. We can automatically and seamlessly import documentation, data and objects from our ERP system into M-Files QMS to create a significantly streamlined process.”
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