M-Files Easy Quality Management and Compliance Solutions Showcased at AME Dallas 2011

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M-Files Document Management for Manufacturing Simplifies and Automates ISO Compliance and the Tracking of Essential GxP, GMP and QMS Documentation and Processes

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Document and process management is a critical component of a manufacturer’s quality operations.

M-Files Inc., the developer of M-Files easy document management software and the cloud-based document management service M-Files Cloud Vault, will showcase its solutions during AME Dallas 2011 on October 24-28, 2011 at the Sheraton in Dallas, Texas. M-Files and M-Files Cloud Vault will be featured in booth 709.

The Association for Manufacturing Excellence (AME) is the premier organization for the exchange of knowledge in enterprise excellence. Members come together during AME Dallas 2011 to explore lean thinking and other enterprise improvement methods, exchange best practices, and network in order to advance their careers and improve the competitiveness and overall value of their organizations.

During AME Dallas 2011, M-Files will feature its solutions for managing, tracking and recording documents and processes to ensure product quality and regulatory compliance for manufacturers. M-Files QMS and compliance features include FDA compliant support for electronic and digital signatures, flexible permission management for strict access control, time-stamped log and audit trail of all activities, automated “mandatory” workflows and processes, and automatic version history. A key advantage of M-Files is that it makes this type of traditionally complex and expensive solution easy to use and accessible to any manufacturer or business implementing quality and compliance initiatives.

“Document and process management is a critical component of a manufacturer’s quality operations. Good manufacturing practice, FDA regulations, ISO requirements and other global regulations and standards require that companies manage versions, control employee access, facilitate training initiatives and implement appropriate change control procedures for essential documents and related processes,” said Greg Milliken, president of M-Files Inc. “Unfortunately, traditional QMS and Compliance solutions that attempt to address these requirements are complicated and expensive. In comparison to these ‘battleships,’ M-Files is a nimble speedboat with all the necessary power, but with an unprecedented level of flexibility and ease of use making it possible to achieve compliance and higher levels of quality and productivity in a more cost effective and dramatically easier fashion.”

With M-Files, manufacturers can control and regulate document access, improve visibility and control revisions across multiple departments, as well as provide the necessary level of automated communication to various stakeholders. Examples of applicable manufacturing documentation include:

  •     Validation documentation
  •     Manuals and employee training 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 (Corrective Action Preventative Action) objective evidence
  •     Certificates of analysis (COAs)
  •     Efficient management of SOPs (Standard Operating Procedures)

M-Files is a flexible and affordable document management solution that enables businesses to make dramatic gains in efficiency and productivity by improving the way they organize, manage and track documents and processes. A key advantage of M-Files is that it can be easily configured to meet the specific and often unique needs of businesses in a variety of industries, including those with demanding records management and regulatory compliance requirements. M-Files eliminates the need for chaotic Windows folders by organizing documents using simple tags and keywords. With M-Files, users store documents in a centralized vault, the same as they would on any other hard drive on their system or network, but rather than repeatedly searching for the right folder, users simply save documents to the vault and tag. M-Files works like Windows Explorer, so the user interface is familiar to any Windows user and minimizes changes to the way employees work. The M-Files vault is accessed just like My Documents or My Computer, it's just faster and more secure, and finding files is as simple as typing in a tag or performing a full-text search right from the Open or Save dialog box of any Windows application. M-Files is also available as a cloud-based service known as M-Files Cloud Vault that runs on the Windows Azure platform, eliminating the need to purchase and configure a server and providing all the benefits of M-Files for a low monthly fee.

About M-Files Inc.
M-Files Inc. develops M-Files professional document management software and the cloud-based document management service M-Files Cloud Vault. M-Files is highly configurable and easy to deploy and use, enabling companies and businesses in a variety of industries make dramatic gains in efficiency and productivity by improving the way they organize and manage their business documents and processes. More than 15,000 customers in over 80 countries worldwide use M-Files to manage their documents. M-Files is available in 24 languages and is in use at customers such as AstraZeneca, BSA LifeStructures, EADS, FinnComm Airlines and Parker Hannifin. For more information, visit us at http://www.m-files.com, the M-Files blog, and follow us on Facebook and Twitter.


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Matthew Meigs
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