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Document Management System

Are You Controlling Your Documents or Are Your Documents Controlling You?

By QEdge Team  Published On October 3, 2024

In the pharmaceutical industry, where precision, safety, and compliance are non-negotiable, proper document management is critical. From production records and SOPs to compliance documents, every piece of information plays a vital role in ensuring regulatory adherence and product quality. However, poor document control can lead to catastrophic consequences—delays, non-compliance fines, product recalls, or even safety risks. Let’s dive into some of the most pressing issues with document management in pharma and how to address them. 

Document Confusion

  • Problem: Employees accidentally use outdated procedures or forms.
  • Solution:Implement a document control system that automatically archives old versions and replaces them with the updated ones, ensuring only the latest procedures are used.

Access Control Issues 

  • Problem: Lack of proper control over who can view, edit, or share sensitive documents.
  • Solution:Opt for a system that provides tiered access control—restricting most documents to view-only, allowing certain users to edit, and giving full control to just a select few.

Document Retrieval Delays 

  • Problem: Searching for specific documents wastes valuable time.
  • Solution:A document control system with advanced search features, tags, and categorization can drastically reduce retrieval time, ensuring quick access to critical documents.

Regulatory Compliance

  • Problem: Struggling to keep up with ever-changing regulations like labeling updates and safety standards, potentially leading to costly fines.
  • Solution:A compliance-ready document control system can automatically update documentation in line with new regulations, ensuring your records are always audit-ready.

Paper-Based Systems 

  • Problem: Paper forms are slow, error-prone, and easily lost.
  • Solution:Transition to a digital document control system starting with the most crucial documents and gradually phasing out paper-based processes for improved efficiency and accuracy.

Audit Preparedness

  • Problem: Not having an organized system to track document changes and access trails during an audit.
  • Solution:With document control software that maintains a detailed audit trail, you can confidently track every document modification, ensuring you’re always prepared for regulatory scrutiny.

Integration with Other Systems

  • Problem: Systems that don't communicate lead to duplication or misplaced documents.
  • Solution: Integrate your document control system with your ERP to ensure seamless tracking and automatic saving of critical records like supplier certifications.

Teamwork Challenges

  • Problem: Emailing documents back and forth for edits leads to version confusion and inconsistent changes.
  • Solution: Use a real-time collaboration system where multiple users can work on the same document while tracking all edits and changes, avoiding the chaos of email chains.

Employee Training

  • Problem: Complex document control systems can make it difficult to train employees, leading to errors.
  • Solution:Invest in intuitive software that is easy for all team members to learn and use, reducing the learning curve and improving adoption.

Scalability Issues

  • Problem: As your company grows, managing more documents becomes overwhelming.
  • Solution:Choose a scalable document control system that grows with your business, handling increased volumes without needing a future switch in software.

Cost of Document Control Software 

  • Problem: Concerns about the upfront cost of implementing a document control system.
  • Solution:Consider the long-term savings. The ROI of reduced errors, faster audits, and minimized regulatory risks makes the initial investment worthwhile.

Take Full Control with QEdge 

Managing your document life cycle doesn’t have to be a nightmare. QEdge offers a comprehensive document control solution that streamlines every aspect—from version control to regulatory compliance, with built-in audit trails for full visibility. Ensure every document is where it should be, up-to-date, and fully compliant with industry standards. With QEdge, you’ll have complete control of your documents, giving you peace of mind and confidence in your compliance processes. 

Take control of your entire document life cycle today.

Book a demo now!

The Future of Quality Management Emerging Trends in eQMS for the Pharma Industry 
The Future of Quality Management: Emerging Trends in eQMS for the Pharma Industry 
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