Document management and control are critical components of a manufacturer’s quality management systems (QMS). ISO compliance, FDA regulations, good manufacturing practices (GMP), standard operating procedures (SOP), corrective and preventative actions (CAPA) and other industry regulations and standards have specific requirements related to documentation. This includes creating and maintaining documents describing key processes and procedures, managing and tracking versions, controlling employee and partner access to documentation, establishing and following appropriate change control procedures, and so on.
M-Files provides manufacturers with a comprehensive and easy-to-use solution for implementing and improving quality management systems by managing and controlling documents and related processes with a single, centralized repository. When documents are managed and readily accessible and workflows are automated and streamlined across the organization in a common and consistent fashion, consistency is enforced, efficiency — and most importantly — quality is improved.
M-Files can organize, manage and track manufacturing-related documents, records and processes to ensure product quality and regulatory compliance, including:
• Validation documentation
• Manuals and instructions
• Project documentation
• Investigation evidence, such as photographs
• Contractor paper batch records and supporting documentation
• Reports and follow-ups from external auditors
• Regulatory submissions and correspondence
• CAPA objective evidence
• Certificates of analysis (COAs)
By efficiently managing and controlling documents and business processes across multiple departments, as well as providing the necessary level of automated communication to affected stakeholders, M-Files enables manufacturers to meet quality standards and ensure successful and efficient compliance audits.