Skip to content
Jeff Thomas01/05/162 min read

Everyone thinks they're compliant... until they find out they're not.

During the everyday course of business, nobody believes that a small aberration here or a miscue there will cause any lasting harm. However, when an FDA or client audit occurs on short notice, all of those seemingly minor errors quickly add up to huge fines, delays, and/or headaches. Without proper and relatively inexpensive compliance procedures, your firm could be in store for a huge penalty.

ZenQMS offers a unique electronic quality management system (eQMS) for regulated companies in the Life Sciences like biotechs, CTOs, CMOs, labs, and packaging and logistics operations among others. Using its advanced software platform, clients are better equipped to avoid potential FDA 483 observations and warning letters.

The ZenQMS platform offers five interconnected modules for Document Management, Training Management, Issues, Change Control, and Audits for a single source of truth. Unlike manual or paper-based solutions, ZenQMS offers instant visibility across the platform for accurate tracking, trend analysis, and reporting. And with access rights based on user roles and permissions for individuals, groups, or the company as a whole, system administrators can control exactly who can see what, and when.

For example, ZenQMS can help a biopharma company restrict its classified documents, allowing only employees with appropriate permission to have access. With this security feature, you can be assured that unauthorized users can't view, tamper with, or steal results, an important part of the compliance process.  

ZenQMS was built to be easy-to-use for emerging and established Life Sciences companies alike. Instead of rigid templates, configurable workflows allow customers to design their system to match their preferences, are as quick to set-up as a Google doc, and meet the highest standards of industry compliance. Paper systems just can't compete with the ZenQMS platform in terms of security, efficiency, and reliability.

Another  feature that makes ZenQMS different is that we don't charge by individual seat licenses. The reason for this is twofold: First, ZenQMS doesn't want to punish you for success. Our simple contracts allow for predicted year-over-year growth, so, unlike other eQMS solutions, you don't have to contact us to add another expensive seat license every time someone joins your team. We want you to scale up and we don't want to hamper that momentum. Second, from Day One, all of your staff have access to all ZenQMS modules. That means no one has to share passwords and risk non-compliance, and your audit trail is clear.

If you're tired of error-prone manual or paper-based QMS solutions and ready to move to an efficient, cloud-based eQMS, read on to learn how to ask for and receive what you want from your life sciences company's senior management.

RELATED ARTICLES