Electronic Document Management (eDMS) vs. SharePoint: Understanding the Scope and Relevance in the Pharmaceutical Industry

Rigorous document management is essential in the pharmaceutical industry to ensure regulatory compliance, product quality, and patient safety. But how do you choose the right document management solution among the many options available, including SharePoint and an EDM system?

First, let’s define the scope of each solution: eDMS and Sharepoint

SharePoint: SharePoint is a highly versatile platform for collaboration and document storage designed to facilitate collaboration within an organization. It allows for file storage, sharing, and organization, but its document management focuses more on collaboration than rigorous document control.

Electronic Document Management (eDMS): eDMS is specifically designed to centrally and systematically manage the entire lifecycle of documents. This includes document creation, capture, classification, revision, approval, distribution, search, and retention.

In the pharmaceutical sector, documents hold paramount importance. The nature and destination of documents are highly regulated, from research and development reports to regulatory submissions, manufacturing procedures, and compliance records. Particularly, documents part of a Marketing Authorization Application (MAA) dossier are paramount.

This is where ProductLife Group comes into play. As a company that supports pharmaceutical businesses, PLG has extensive experience managing critical documents related to marketing authorization applications. Their expertise in regulatory compliance, sensitive document management, and data security makes them the ideal partner for pharmaceutical companies seeking to optimize their document management.

EDM offers the following advantages

• Structured Management: Documents are classified and organized logically, facilitating search and access, especially for key documents within the MAA dossier.
• Compliance: Version tracking, access rights management, and document retention functions ensure compliance with regulatory standards, particularly for documents submitted to regulatory authorities.
• Security: Data is secure and protected, mitigating the risks of sensitive information leakage, especially concerning confidential data within the MAA dossier.
• Traceability: Every modification or action on a document is recorded, creating a comprehensive audit trail crucial for submission documents.
• Automated Workflow: Validation and approval processes are automated, reducing delays and errors, which is critical for documents submitted to regulatory authorities.

Overall, eDMS can be the perfect tool to efficiently and compliantly manage many critical documents, focusing on sensitive documents related to marketing authorization applications. Partner with us to help you select the best solution and ensure the success of your regulatory projects. Check out how PLG can support your implementation of an eDMS as part of our Cloud Solutions packages.