M-Files Makes QMS Easy – Ensure Quality and Compliance with Effective Information Management

eBook

Companies that operate in highly regulated and frequently audited environments are often challenged with managing an ever-growing mountain of compliance documentation.

The stakes are high for these companies to ensure they are managing their compliance-related information in accordance with mandates, due to crippling fines and liability issues that can result from non-compliance. However, many companies still maintain manual processes for routing, filing and organizing compliance-critical documentation. These error-prone and time-consuming practices present a major risk and can easily compromise a company’s ability to meet  ISO 9001, PoPI Act  and other regulations and standards.

Given the high priority for regulatory compliance and the amount of documentation required to prove compliance, it is no longer practical to manage the content separately from compliance efforts. If compliance management teams are asking themselves the following questions, chances are their organization is at significant risk for non-compliance due to inadequate content management practices and procedures:

  • Where is the gatekeeper? Do compliance management processes slow or stop production when a key person is sick, on vacation or exiting the company?
  • Has everyone read the latest compliance-related communication? Is it difficult to get the accurate status about compliance-related tasks, procedures and workflows?
  • Are policies being followed and schedules being met? Who has visibility over the completion of the specified processes?
  • Where are the required signatures? How easy is it to locate the documents that verify the approval processes?
  • Have all of the audit issues been resolved? Are employees and managers barraged with repetitive reminder emails while the status of essential action items remain unclear to key stakeholders?
  • Is compliance slowing down the business? Is the organization at a competitive disadvantage because it takes a long time to adjust to the latest regulatory compliance requirements?

Find out more, download the eBook – Ensuring Quality and Compliance with Effective Information Management… QMS is easy with M-Files

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QMS is easy with M-Files…

Leveraging Information Management To Improve Quality Systems and Regulatory Compliance-Recovered

Companies are Leveraging M-Files Information Management To Improve Quality Systems and Regulatory Compliance.

Companies that produce products with rigorous quality requirements face numerous challenges associated with meeting quality objectives—ranging from the need to comply with quality standards (such as ISO 9001, FDA 21 CFR Part 11, CGMP and EU GMP Annex 11) to operating in highly-regulated and frequently audited environments.

Organizations of all sizes and across all industries can easily fall prey to quality issues without effective information controls as a core component of their quality management systems. The result can range from organizational inefficiencies and poorly allocated resources to negative brand perception, lost revenue and increased liability. Without a centralized and organization-wide approach to managing their content, companies leave themselves vulnerable because of the difficulty and complexity of managing critical and sensitive information and processes that affect quality and compliance. Establishing document and data control processes within a quality management framework improves manufacturing and production processes, enhances collaboration, better utilizes existing resources, and drives organizational efficiencies that affect a company’s bottom-line business objectives.

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