The pharmaceutical industry is highly regulated and complex, with strict requirements for document management. Paper-based document management is no longer feasible in this environment, as it is inefficient, error-prone, costly, and challenging to comply with regulations. On top of everything, paper documentation causes huge environmental pollution. 

Every year, $25-35 billion is spent in the U.S. on filing, storing, and retrieving paper documents which are very costly for businesses. (Digital Filing)

Paper, in the average business, is growing by 22% a year, meaning your paper usage will double in 3.3 years.

Pulp and paper is the third largest industrial polluter of air, water, and land in Canada and the United States, releasing well over 100 million kg of toxic pollution each year.

If the current rate of deforestation continues, it will take less than 100 years to destroy all the rainforests on the earth. (DocuPhase)

Digital transformation (e-document management system) can reduce natural resource consumption, pollution, and waste, and also provide major business performance benefits such as increased efficiency, agility, and productivity. (Forbes)

Going paperless is a simple way to make a big difference for the planet.

Benefits of Electronic Document Management System (EDMS) in Pharmaceutical Industries

An EDMS is a software solution that helps pharmaceutical companies to manage their documents electronically. EDMSs offer a number of benefits over paper-based document management, including:

• Improved efficiency: EDMSs can help to streamline document handling processes, reducing manual tasks such as filing, sorting, and searching for documents. This leads to increased efficiency and productivity across departments.
• Enhanced collaboration: EDMSs can help pharmaceutical companies to improve collaboration by making it easier for team members to share documents and collaborate on projects. This can lead to better decision-making and faster product development.
• Better compliance: EDMSs can help pharmaceutical companies to comply with a variety of regulatory requirements, such as those imposed by the FDA, EMA, and MHRA. This is because EDMSs can help companies to track and store documents in a way that is secure, auditable, and accessible.
• Cost savings: EDMSs can help pharmaceutical companies to save money by eliminating the need to print, store, and physically manage paper documents. This can save companies on printing costs, storage costs, and labor costs.
• Data integrity and security: Protecting sensitive information and maintaining data integrity is crucial in pharmaceutical operations. EDMs provide robust security features, such as access controls, encryption, and audit trails, safeguarding against unauthorized access, tampering, or data loss.

Key Features of Electronic Document Management System (EDMS) for Pharmaceutical Industries

The key features of EDMSs for pharmaceutical industries aim to improve efficiency, data integrity, compliance, and collaboration, while also ensuring the security and accessibility of critical documents throughout their lifecycle. These features include:

• Document access control: EDMS allows administrators to set access permissions based on user roles and responsibilities. This ensures that sensitive or confidential documents are only accessible to authorized personnel, enhancing data security.
• Version control: EDMS supports version control. This means that users should be able to track changes to documents and restore previous versions of documents.
• Audit trail: EDMS provides an audit trail for documents. This means that the system should track who has accessed and modified documents, and when.
• Electronic signatures: EDMS supports electronic signatures to validate document approvals and ensure compliance with electronic signature regulations, such as 21 CFR Part 11.

Best Practices for Implementing Electronic Document Management Systems (EDMS) in Pharmaceutical Industries

Implementing an EDMS in the pharmaceutical industry requires careful planning, adherence to regulatory requirements, and consideration of specific industry needs. Some best practices for implementing EDMSs include:

• Define document types and workflows: This is a critical best practice for implementing EDMSs in the pharmaceutical industry. By defining document types and workflows thoughtfully, pharmaceutical companies can streamline their document management processes, improve compliance, and enhance overall efficiency in their operations.
• Establish document review and approval processes: The establishment of robust document review and approval processes is one of the most critical best practices when implementing EDMSs in the pharmaceutical industry. These processes ensure that documents undergo thorough scrutiny, verification, and endorsement before they are considered valid and authorized for use.
• Train employees on the system: Proper training ensures that all users understand how to effectively utilize the system, resulting in increased efficiency, reduced errors, and enhanced compliance. By prioritizing employee training, pharmaceutical companies can ensure that their staff is well-prepared to utilize the EDMS efficiently, leading to improved document management, compliance, and overall productivity.

Examples of Electronic Document Management Systems (EDMS) in Pharmaceutical Industries

Here are 10 examples of mostly used Electronic Document Management Systems (EDMS) in the pharmaceutical industry:

1. Alfresco is a leading open-source EDMS that is highly scalable and customizable. It offers a wide range of features, including version control, workflow management, and document search.
2. DocuWare is a commercial EDMS that is known for its user-friendly interface and powerful search capabilities. It also offers a wide range of integrations with other software applications.
3. Fiix is a cloud-based EDMS that is designed specifically for the pharmaceutical industry. It offers a number of features that are tailored to the needs of this industry, such as compliance tracking and audit trails.
4. IBM Content Manager is a commercial EDMS that is known for its security and reliability. It offers a wide range of features, including document classification, workflow management, and auditing.
5. Infor EAM is a commercial EDMS that is designed for enterprise-wide use. It offers a wide range of features, including document management, asset management, and compliance tracking.
6. OpenText Documentum is a commercial EDMS that is known for its scalability and flexibility. It offers a wide range of features, including document management, workflow management, and content analytics.
7. SAP Document Manager is a commercial EDMS that is integrated with SAP’s other business applications. It offers a wide range of features, including document management, workflow management, and compliance tracking.
8. Xerox DocuShare is a commercial EDMS that is known for its ease of use and integration with other Xerox products. It offers a wide range of features, including document management, workflow management, and mobile access.
9. TrackWise Document Management System is an EDMS that offers a wide range of features, including document management, collaboration, and access control & audit trail. 
10. Microsoft SharePoint is a collaboration platform that can be used as an EDMS. It offers a wide range of features, including document management, workflow management, and search.

Conclusion

EDMSs offer a number of benefits to the pharmaceutical industry, including improved efficiency, compliance, security, and collaboration. By following the best practices outlined in this article, pharmaceutical companies can ensure that the implementation of their EDMS is successful.

Successful implementation of EDMS will be a great step to make a big difference for the planet.

If you want to learn more about E-Document Management Systems, please email to info@1qualitysolutions.com