An Electronic Quality Management System (eQMS) is a new digitalized approach towards Quality Management Systems (QMS). By using advanced IT infrastructures and technologies, the eQMS supports efficient processes and avoids unnecessary mistakes.

The main difference between QMS and eQMS is the methods and processes they use to manage documentation. A QMS typically relies on paper-based records and documents to adhere to the regulatory requirements. The eQMS builds on top of the traditional QMS methodology and uses software instead of paper. All of the documents are therefore digitally stored in the Quality Management System Software, which enables the use of automated workflows and Electronic Signatures instead of wet signatures. On another note, what is QMS responsible for in the first place?

What is a QMS?

A QMS is typically defined as a system that documents policies, processes, internal rules, procedures, and other records to ensure consistent quality and high customer satisfaction. ISO 9001:2015 is the primary regulatory guideline that was built to ensure that a certain standard is upheld across different industries.

Quality Management System Modules

QMS in Life Sciences

However, the emphasis on quality and customer satisfaction is especially high in the field of life science. And for a good reason. Small details, unnoticed risks, or unaddressed errors can often translate to the difference between life and death. An efficient system that ensures Standard Operating Procedures (SOPs) are properly adopted and upheld among personnel is imperative.

Furthermore, pharmaceutical and medical device companies need to uphold a higher degree of industry-specific regulatory requirements.

ISO 13485:2016 is a regulatory standard for Medical Device companies. It is an additional regulatory requirement based on ISO 9001, which itself is the only standard in the ISO 9001 series which firms can certify to.

ISO 13485:2016 has 8 sections, where section 4-8 provides all of the necessary requirements that must be included in the Quality Management System of medical device oriented companies. This also includes companies that are part of one or more life-cycle stages of the medical device development process. The fastest way to get an ISO 13485:2016 certification is to have a reliable, efficient QMS that complies with ISO 13485:2016 regulations.

GxP is a collection of regulatory guidelines that adhere to the good practice of manufacturing, storage, distribution, review, etc. of products for Pharmaceutical companies. GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP (Good Laboratory Practice) are the most essential practices for any product life cycle in the Pharmaceutical industry.

The GxP guidelines mainly focus on a high level of traceability, accountability, and data security. Therefore, the fastest way to work towards GxP excellence is to have a QMS that complies with ISO 9001:2015 in addition to the GxP specific regulations.

Life Science QMS Certifications and Guidelines

Problems With a Traditional Paper-Based QMS

The Paper-based QMS has been around, well, since Quality Management was around. As time went by, more and more issues appeared, a workaround was created, and then the issues reappeared at another point. These are some of the issues that organizations typically struggle with when they have paper-based Quality Management Systems:

  • Limited traceability of documents and processes
  • A high number of progress check meetings
  • Lack of access to the paper archive
  • The burdensome and challenging design transfer process
  • Complicated risk management and risk analysis
  • High risk of misfiled or lost documents
  • Obsolete and out of sync records in circulation
  • High risk of missing signatures during an audit
  • Lack of accountability and visibility within teams
  • Hard to keep an up to date DHF throughout the product lifecycle
  • Ineffective and lengthy authoring processes
  • High costs connected to inefficiency, mistakes, and corrective measures

Do you find yourself facing one of these issues? Write to us and let’s talk about your specific problems and how can we solve them together.

How Does a Good eQMS Tackle These Issues?

Each eQMS provider has its own set of solutions and tools that deal with specific problems. So, we can’t promise that each eQMS out there is equipped to deal with these issues, however, we can explain possible ways in which Quality Management System Software handles these problems.

Common QMS IssueseQMS Advantages
Limited traceability of documents and processesDetailed log of all revisions, signatures, and updates
A high number of progress check meetingsAutomatic change & request notifications to specific personnel
Lack of access to the paper archiveAccess to all documents at any time, from any place
The burdensome and challenging design transfer processAll DHF files for each product are safely stored in the system
Complicated risk management and risk analysisAccess and traceability of Risk management file, SOPs, etc.
High risk of misfiled or lost documentsElectronic document control with built-in mandatory fields, and software hosted on Cloud-based data centers
Obsolete and out of sync records in circulationAccess to all documents and their last version or status
High risk of missing signatures during an auditUnsigned documents are automatically flagged
Lack of accountability and visibility within teamsLog of revisions, dates, and employees who authored or reviewed the documents
Keeping an up to date DHF throughout the product lifecycleTraceable and easily accessible DHF for all products
Ineffective and lengthy authoring processesAll documents are easily accessible via software
High costs connected to inefficiency and mistakesReduction of costs due to decreased margin of error

What Forms of Digital Archives Are Not Validated?

Okay, okay I get it, you already have a digital archive for your QMS documents. Services like file servers, Dropbox, and SharePoint are cheap and easy to use. Although these services lack some nice-to-have features they already solve many of your problems and you don’t want to spend more money and time. The problem is that these services are not necessarily meant for keeping and controlling digital records in the life science industry. Therefore, they often lack the necessary certifications and validations.

Using non-validated software to handle your records and documentation is the quickest way towards non-conformances.

It’s tempting to use these alternatives instead of a purely paper-based Quality Management System. They offer easier accessibility to your documentation but one of the main issues is that many services are not compliant with FDA CFR 21 Part 11. Neither do they follow other relevant standards such as ISO 27001 or ISO 13485, which are essential when it comes to striving for good practices (GxP).

Mentioning ISO 27001, it’s important that your eQMS provides a satisfactory level of security. Although ISO 27001 is only a guideline, not adhering to it can cause leaks of sensitive data and expose you to numerous vulnerabilities.

Essential Elements of a Good eQMS

Now when we have discussed the wrong way of implementing a digital Quality Management System let’s discuss the right way to do it.
First, the system must be validated and compliant with FDA CFR 21 Part 11. In addition to this certification also check for ISO 27001, ISO 9001, and ISO 13485 (for medical device companies) in your Quality Management System software of choice. These guidelines provide needed security and standardized regulatory requirements for Quality Management Systems.

Make sure to ask the vendor how validation is performed and who takes care of this task. Ensuring that your eQMS is continuously validated when the software or hardware changes can be a challenge. Therefore, you can opt for a Pre-Validated System, which has a standardized process and does not require time and expertise for the validation process.

Next, it’s important to find out what are the hosting options of the solution. Non-cloud-based options will usually require you to set up your own servers and IT guidance which might end up only increasing your costs.

Finally, support and the length of implementation can tell a lot about the company´s experience with regulatory affairs and customer satisfaction.

Frequently Asked Questions About QMS

What Is Quality Management System Certification?

ISO 9001:2015 in the international standard for specifying requirements for quality management systems. ISO 9001 is the only standard in the ISO 9000 family to which firms can certify to.
Furthermore, organizations operating within specific industries have to meet additional regulatory guidelines. For example, ISO 13485:2016 specifies requirements for a quality management system of medical device-related companies where a firm needs to demonstrate its ability to meet the regulatory requirements to be certified.

What Is the ISO Definition of Quality?

ISO 9001:2015 clause 3.6.2 defines quality as: “Degree to which a set of inherent characteristics of an object fulfills requirements”. In other words, an object (product, service, process, person, organization, system, resource) that complies with specified requirements.

What Is the Purpose of a QMS?

A quality management system (QMS) is not just a collection of documents, instead of a group of various business processes whose purpose is to meet customer requirements, leading to an increase in customer satisfaction. It is also aligned with an organization’s values and its strategic goals.

What Are the 7 Quality Management Principles?

The seven quality management principles are:
1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvements
6. Evidence-Based Decision Making
7. Relationship Management

Final Thoughts

A quality management system (QMS) documents policies, processes, internal rules, procedures, and other records to ensure high quality and customer satisfaction. An electronic quality management system (eQMS) allows performing the operations digitally.

ISO 9001:2015 in the international standard for quality management systems. Additional certifications and guidelines differ based on the industry.

EQMS outperforms traditional, paper-based quality management systems allowing easier traceability and more efficient workflows. Dropbox, SharePoint, Google Drive, and other file hosting services are not necessarily meant for keeping and controlling digital records. Therefore, they often lack the necessary certifications and validations.

Some of the most elements of high-quality eQMS are the necessary certifications, cloud-based hosting, training, and client support.