Bio-Botanica Leverages M-Files QMS for Product Documentation Management, Information Management, Workflow Processes and Audit Administration

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Botanical Product Manufacturer Integrates Metadata-powered Quality Management Solution with ERP System for Improved Data Control.

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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.

M-Files Inc., the developer of M-Files cloud, on-premise and hybrid enterprise content management (ECM) solutions that manage information by what it is versus where it is stored, today announced that Bio-Botanica, a manufacturer of botanical products for the cosmetic, personal care, pharmaceutical and nutraceutical industries, has implemented M-Files QMS to manage its batch product manufacturing documentation and process flow.

Bio-Botanica manages a significant amount of regulatory information, R&D documentation and specification data associated with each product the company manufactures. Bio-Botanica was managing much its product information and associated processes via a system that relied primarily on paper and email, and realized that a transition to a faster, more efficient and scalable system was necessary to enable the company to keep up with the growing demands of its business.

M-Files QMS enables Bio-Botanica to establish a single repository to more effectively manage product documentation securely. This process is handled behind its firewall to ensure only the most current and up-to-date information is available. In addition, the company has established permission controls and utilized the workflow capabilities in M-Files QMS to automate critical compliance-related processes to ensure only authorized individuals can access, edit and approve specific documents and other information. Bio-Botanica is also leveraging M-Files QMS to institute a smoother and more transparent audit process.

"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," said Jason O’Neill Director of Sales at Bio-Botanica. "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 these 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."

"As a company that generates a substantial volume of critical and frequently changing compliance-related documentation, Bio-Botanica understands the value and importance of efficiency and consistency when managing, securing and sharing information," said Greg Milliken, president of M-Files Inc. "M-Files QMS enables Bio-Botanica to enhance the quality of its documentation and processes by providing a standardized means of flexibly organizing mission-critical information by product in a single repository. This ensures that only the most current versions of documents are utilized by designated individuals. In addition, M-Files QMS enables Bio-Botanica to administer consistent workflow processes and furnish a complete audit trail, which is vital for change control requirements and compliance with regulation 21 CFR Part 111."

Integration with ERP Ensures More Efficient Processes

Bio-Botanica deployed M-Files QMS to improve document control for their product batch testing processes in a manner that integrates seamlessly with their existing ERP system (Infor -Visual ERP). Product and raw material information from their ERP database is automatically imported into M-Files.

"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," added O'Neill.

About Bio-Botanica

Bio-Botanica® is a family-owned and operated company, specializing in botanicals for over 40 years. The company is a leading manufacturer of 500+ quality botanical extracts for the cosmetic, personal care, pharmaceutical and nutraceutical industries. A well-recognized industry innovator known for pioneering numerous advancements in the botanical field, Bio-Botanica® prides itself on long-term customer relationships since 1972. For more information, visit

About M-Files QMS

M-Files QMS is a practical and easy-to-use solution that helps manufacturing organizations and related businesses fulfill the documentation and data requirements associated with quality standards such as ISO 9001, CE marking or labeling, compliance with FDA 21 CFR Part 11 and EU GMP Annex 11, and audits associated with all of these activities. M-Files QMS is ideally suited for businesses in regulated industries such as pharmaceutical and life sciences, petrochemicals and other process-related manufacturing sectors, food production, transportation (including aviation, automotive, etc.), mining and others. For more information, visit

About M-Files Inc.

M-Files enterprise content management (ECM) solutions transform how businesses manage, secure and share information with a unique metadata-powered approach that organizes and processes content based on what it is, rather than where it resides. Thousands of businesses in over 100 countries use M-Files on-premise, in the cloud or in hybrid environments to improve productivity and quality, and to ensure compliance with industry regulations and standards, including companies such as SAS, Elekta and EADS. For more information, visit

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Matthew Meigs
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