<img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=489233&amp;fmt=gif">

Requirements of a Quality Management Software for the pharmaceutical industry


Pharmaceutical organizations are rapidly catching up with the latest technologies in the era of cloud-based platforms. Several companies are opting for the software enablers for the ease of communication, project management and automation. One such technology is a cloud-based Quality Management Software which is fondly referred to as e-QMS too. These days, every pharmaceutical organization is migrating from paper-based QMS to paperless e-QMS, and start-ups are opting for the e-QMS right from the beginning. 

Screen Shot 2021-06-03 at 12.38.39Therefore, it is crucial to do thorough research on Quality Management Software's requirements before procuring one. The research will help you assess the supplier services for Quality Management Software and frame your requirements to the suppliers. This article will describe the three basic requirements that can be useful for you to communicate your requirements to the software supplier.


1. GxP Requirements

It goes without saying that regulations bind everything in the pharmaceutical industry. There are several regulations which apply to Europe and the USA region as follows:

The regulations mentioned above are GMP and related regulations. Apart from these regulations, there are some International Standards defined by ISO as follows:

Although all these regulations share the same objectives, there is a likelihood that some regulations may have a more extensive scope than others. Therefore, it would be worth to go through ICH Q10 published by the International Organization for Standardization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidelines are useful to have a harmonized understanding of the subject matter. It is primarily based on the various regional GMP regulations, and the ISO published standards.

The GxP requirements are the heart of Quality Management Software. It is absolutely essential to meet GxP requirements applicable to the business region.

If your Quality Management Software does not comply with the GxP requirements, you may also get an observation in the regulatory audits. The observation can also result in an import alert if the risk associated with the non-compliance is very high. That is why it is impossible to play around with the GxP requirements in Scilife e-QMS, which otherwise offers many exciting configurable features to suit your business requirements.


2. User Interface

If you are satisfied with the GxP requirements, the next step is to evaluate Quality Management Software's intuitiveness. You can understand this by scheduling a demo. It will give you an overview of the user interface and workflow within the software.
Some basic things about user interface you can evaluate are as follows:

    • Readability
      Is the text readable? Is the font size sufficient? Is the Font color distinctly visible against the background?
    • Appearance
      Is the appearance professional? Is the content well organized?
    • Simplicity
      Is the user interface over-complicated? Can you figure out the workflow by taking a look at the user interface?
    • Navigation
      Is the navigation process intuitive?
    • Menu Options
      Are the Menu items self-explanatory? Is there a help menu option within the software?
    • Form Fields
      The first thing which you should check is the completeness of the form fields. Are the form fields self-explanatory? Will the user experience any difficulty in entering the most relevant information in the fields?

3. Business Integration

If you are happy with the user interface, the next stage is to understand if it can be integrated into your existing system. Some questions which will help you to understand the suitability of the software for business integration are as below:

    • Do you need an SSO option?
    • Will the software provide you with enough storage space to store your documents?
    • What is the file size the software can handle?
    • At what speed do you need the pages to load?
    • Can you configure the software according to the functions or processes within your organization?
    • Will you get additional support for software validation, maintenance, upgrades and feature requests?
    • Will you get extra support for migrating from the old system to the new system?


How Does Scilife Meet the Requirements


At Scilife, we strive to provide more than what our customers need. Usually, the basic unsaid requirements are the must-have requirements. In the case of Quality Management Software, these requirements are GxP requirements.

Therefore our customers can be 100% assured that the software which they purchase meets all the must-have GxP requirements.

But as I said, we strive to cater more than just that as we provide an extremely user-friendly interface and excellent support for business integration.

Scilife offers a systematic onboarding process. The onboarding process covers training, validation and data import support.

A Project Manager is assigned to track and facilitate the onboarding process. As a result the transition from old system to new system is effortless.

Scilife users can raise help tickets or feature requests anytime during their subscription period.

Many of Scilife’s existing users find this to be an irresistible wow factor while making the purchase.



We hope that this article was useful to you for framing requirements of the e-QMS. Defining your needs is the first step of procuring the best Quality Management Software. A well-defined requirement also enables you to rank the importance of requirements by considering the risk involved in terms of non-compliance. As a buyer, the basic minimum that you should expect is a GxP compliant software solution. However, the differentiating factor for choosing the service provider should depend on the user-friendliness, ease of business integration, software validation status, pre and post-sales support. As we aim for more than 100% customer satisfaction, we score 10 out of 10 in all these requirements.

The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to...