Are you thinking about buying eQMS software for your company? Then, you should know that this decision impacts client satisfaction. Do not choose your IT solution without reading this post first.

The eQMS (electronic Quality Management System) software is what allows us to manage all aspects related to the quality of our products or services (from design to distribution). It is, therefore, a very valuable tool when it comes to reducing errors, automating processes, and above all, guaranteeing success in external certification audits or evaluations by Notified Bodies.

Being directly related to improving quality and regulatory compliance, the eQMS software plays a very important role for any company. Not in vain, it is vital to transform quality management from reactive to proactive. That is why we cannot take its selection lightly.

5 keys to choosing your eQMS software

The remarkable increase in clients and business processes has led digital quality management to displace classic manual documentation. That is why eQMS technological solutions have become indispensable. However, it is only fair to recognize that not all of them are equal. Stay with us to learn what aspects define these IT systems.  

eQMS software features

Of course, not all eQMS have the same functions nor do they cover the same management areas.

  • Some focus on specific aspects (document control, audits, non-conformities, manufacturing guides, etc.). Others, on the other hand, provide comprehensive solutions that cover the entire product lifecycle of your company.
  • There are quality management solutions designed for specific sectors (such as pharmaceutical and/or medical). Likewise, it is also possible to find more generic softwares adaptable to different industries.
  • Some comply with regulations in certain markets, and others are global solutions that will accelerate access to multiple markets.

In any case, before deciding on an eQMS solution, you must carefully analyze what your company's needs and requirements are regarding quality and the regulatory requirements of the markets where you commercialize. Only then will you know what type of eQMS software is the solution that best fits your company.

Price

There is no doubt that, after analyzing the features of the software, cost is the second most relevant factor you must consider. Therefore, before deciding on one for your business, you should compare the different available alternatives and evaluate which one offers you the best value for money.

It is evident that the wide range of eQMS systems offers numerous prices and these, in turn, are conditioned by several factors:

  • Number of users.
  • License types.
  • Customization level.
  • Technical support.
  • System updates.
  • Compatibility with other software.
  • Features and usability.

It is important to point out that, when we talk about prices for this type of software, we do not only refer to the initial payment but also to associated costs (maintenance, training, integrations, etc.). That is why you need to consider which concepts are included or excluded from the price (technical support, updates, migration, validation...).

Otherwise, you should choose the program based on the budget your company has. In any case, it is convenient to calculate what ROI you expect to achieve with it, in order to select the system that is capable of providing greater long-term benefits.

Technical support

Technical support is another of those crucial aspects you cannot overlook when deciding to purchase eQMS software. We are talking about a detail that will determine the success or failure of its implementation and use.

Just as with the features of the software, not all technical supports are equal. Now then, when are we facing good technical assistance? Pay attention to the following aspects:

  • Provides professional assistance, not only at the time of installing the software, but also during its operation.
  • Provides periodic updates to the system, in order to guarantee its optimal performance and adaptation to regulatory or technological changes.
  • Offers multiple contact channels and extended customer service hours so you can resolve doubts and incidents with maximum agility and convenience.

In reality, technical service quality is closely linked to the reliability of your technology provider. In fact, only when it has sufficient experience will it be able to guarantee that implementation and maintenance of the program are truly satisfactory.

Compatibility

We cannot forget that eQMS software is called to integrate with other technological solutions. For that reason, you should stop and consider how important integration with other programs is for your company: ERP (Enterprise Resource Planning).

  • CRM (Customer Relationship Management).
  • LIMS (Laboratory Information Management System).
  • Project manager (Jira or others).
  • Microsoft Office package.

Harmonious compatibility significantly improves information and data flows between different departments.

Security

Security is another fundamental aspect you must consider when choosing eQMS software. After all, this system must comply with the relentless standards imposed by data protection regulations (insofar as it stores and manages them).

An insecure eQMS program is a real source of problems for any company. Some of the risks it implies are sensitive information theft, hacking (for example, by a competitor), or the imposition of fines for non-compliance with regulations.

Among the functionalities that determine the security of a quality management program, we can highlight the following:

  • Data and document encryption (whether in transit or not): prevents them from being intercepted or decrypted by third parties.
  • User authentication and authorization and their roles: controls not only who can access, but also with what permissions.
  • Auditing and logging of all activities performed with the program: allows tracking who did what, when, and why.
  • Backups and recovery: will be of great help when restoring lost or damaged data and documents, whether accidental or intentional.
  • Certification and compliance with standards and safety regulations among the most demanding (such as ISO 27001, GDPR, or HIPAA).

From Ambit BST we help you choose your eQMS software

At Ambit we have been developing IT strategies and solutions for companies like yours for over 15 years. We are partners with the main eQMS developers for the pharmaceutical and medical device sectors.

We take care of evaluating your needs and offering the best solution for your company considering required features, price, implementation time, technical support, and compatibility.

Complementing the choice of eQMS, we provide training services, regulatory advisory, computerized system validation, and outsourcing so you can implement the eQMS software with maximum efficiency and security. Resolve all your questions by contacting us.

 AMBIT BST

At AMBIT we have been experts for over 15 years in the development of IT strategies and solutions for your company. We are consultants and integrators across multiple domains, and if you want to learn more about the solutions we can offer you, do not hesitate to contact us.