You might have come across the terms electronic Quality Management System (eQMS) and electronic Document Management System (eDMS). But what exactly is the difference between these terms? Read here to understand the specifics.
electronic Quality Management system (eQMS)
An eQMS is defining the electronic processes needed in a Quality Assurance setting. These processes usually include the procedural documents, often referred to as Standard Operating Procedures (SOP) as well as the procedures for CAPA, non-conformances, complaints, audits, change control, supplier management, etc. Thus, an eQMS contains the procedures as well as the records in relation to the Quality Assurance and Quality Management of a company.
Further, the eQMS and its documents support the compliance towards Standards for Quality Management Systems, whether these are ISO 9001, ISO 13485, or GMP.
Electronic document management system (edms)
An eDMS, as its name already reveals, is an electronic system to manage documents. Whether these documents belong to the Quality Management System, the product development, human resources, legal or any other sort of document is irrelevant. Modern eDMS support all kinds of document file types, whether it is a Microsoft Word, PDF, 3D Drawing, pictures, or other, it all can be stored in the eDMS.
Further, eDMS usually come with some sort of functionality as versioning, archiving, approval workflows, and categorization, to name a few.
In need of an eDMS/eQMS? Speak to us and get your free consultation on these systems.
Commonalities of eQMS and eDMS
As the differences have been explained in the definition and purpose of each term, let’s see what commonalities these systems share.
- When used in regulated industries, data integrity and data security become inevitable. Thus only validated systems may be used. Here, GxP compliance, as well as GAMP5 validation, are some approaches used.
- When used to digitally sign documents or records, eSignature validation is a must. Here, compliance to 21 CFR 11 and EU GMP might have to be shown.
- Backup plans and backup schedules are commonly asked for during audits
- Data storage premisses are under the spotlight as well. Applicable laws for privacy need to be respected when selecting the location of the data center.
- The data center certification for data security might be of interest as well. Here, Tier-levels are widely used along with the ISO 27001 certification.
How Avanti Europe can help
Avanti Europe’s Experts have a decade-long track record and expertise in consulting and hands-on working with different eQMS and eDMS in the Pharmaceutical, Cosmetical, and Medical Device industry. Our experts support your company with hands-on workforce and support in risk-based process design, documentation, and training for the company staff. Visit our online shop for checklists and other services.