ZenQMS
Enhanced Compliance at an Affordable Price

The keystone of any organization is an effective and automated Quality Management System (QMS), and though a number of businesses have realized it, many are still living under the rocks. Several reasons can be attributed behind this lacking, but one of the most common ones is the cost and complexity of solutions that dominate the current market, making CEOs and CIOs to think twice before switching to any other new system. One such person that also faced the issues with the paper-driven QMS was Panos Boudouvas, Co-founder and CEO of ZenQMS. In his initial career days, Boudouvas struggled with paper, or homegrown tools for managing SOP’s, audit responses, CAPA’s and several more. Not only was this but the company he worked for ran out of space for its paper files, which made reporting and analytics a nightmare, so was retrieving documents. He says, “It was a compliance red flag for all external clients and regulators, which put us at an increased risk of failure.” That’s when Boudouvas decided to lay the foundation of ZenQMS in 2010 to address these challenges with an easy-to-implement, affordable quality management solution for the whole enterprise. “We developed amazing, cloud-based Quality Management Software (QMS) platform to provide professionals enhanced compliance at an affordable price,” states Boudouvas.

ZenQMS’ platform includes modules for Document Management, Issue/CAPA, Change Control, Audits & Supplier Management, and Training, which provides companies with a remarkable prospect to enhance compliance. The firm’s accounts modules come with compliant signatures that help businesses in saving a lot of money. Since ZenQMS is a pure Software-as-a-Service application, users only need an active internet connection and a browser to start with while eliminating the costs and delays linked with the traditional approach to software deployment.

Built for compliance, ZenQMS consists of GxP, ISO, and e-signatures, and maintains a fully validated instance in the cloud at all times. The solution is also easy to implement as the staff at ZenQMS leads a turnkey execution, including data training and migration. Other key features of ZenQMS are it takes the pain out of compliance, no splitting hairs, it is fully cloud-based, and always audit ready.

Factors Defining ZenQMS Platform

The key factors that differentiate ZenQMS platform are its document collaboration and control that are at the core of QMS. It includes keyword search documents, data, and the attachments; defined workflows: approval, review and retirement; revision and version management; and advanced security features for exported files.

The cloud-based eQMS platform takes the pain out of employee training, and compliance as businesses can use courses and groups to impersonate their training matrix. It also comes with integrated proficiency testing and training event logging, instant visibility into both individual and group training statuses, and automatically alert users when training or re-training is due.

It is widely known that investigating issues are always complex, but with the eQMS platform, it can be sorted. The standard approach to investigations/CAPAs can support the business process; automated issue notification and investigator assignment; configurable workflow and verification steps, including effective checks; and keyword searchable issues, which can be linked to unlimited CAPAs.

ZenQMS’ platform also makes supplier qualification audits simple with its easy to maintain schedule complimented by recurring audits, keyword search audits, observations and attachments, custom audit sections and workflow approvals; and assign observations to users or link to investigations. The platform is fully validated for compliance and regulatory requirements concerning several industries, meaning clients can avoid the costs and delays linked with the conventional approach to software deployment.

Moreover, ZenQMS believes in transparency and aims to set its customers up for success.

We developed amazing, cloud-based quality management software (eQMS) platform to provide professionals enhanced compliance at an affordable price

So, the firm does not count seats and lets its users to only pay for what they need. ZenQMS’ cloud-based platform is quite different from its market competitors and does not require the rebuilding of a new application for each of its customers. “Affordability and transparent pricing were part of our founding principles. There are no users’ seat licenses or costs for storage–you pay based on what is in your account. So getting started with ZenQMS does not require a lot of money or resources,” remarks Boudouvas.

A Right Fit Solution for Regulated Market

Most of the clients of ZenQMS are in the Life Science space – Pharmaceutical, Biotech, Medical Device, CROs, CMOs and several more. Since the firm’s system is highly configurable, there is no business too small or too large to get help from ZenQMS. “Users want software that is as easy to use as Gmail or their iPhone. The key difference in regulated environments that we operate in, Pharma, for instance, is that these solutions must be robust and validated for compliance with existing regulations and standards. This has long been held out as an excuse to limit innovation, but at ZenQMS we started with the premise that we could find a way for software innovation to thrive in a regulated environment,” says Boudouvas.

Since 2010, ZenQMS is serving its clients with utmost care and efficiency. Though any regulatory agencies or certification authorities do not certify the firm, its infrastructure partner, Amazon Web Services (AWS), maintain several certifications and inbound regulatory and accreditation audits, including SSAE 16 reports (SOC 1/2/3) and ISO 27001. ZenQMS also releases its significant upgrades at least three times a year and deliver release notes, validation documentation, and a test environment to all its clients. The firm’s staff manages every release under change control, which consists a full complement of validation documentation, including URS, FRS, validation plan, IQ/OQ/PQ, Trace Matrix and several more. It provides all its upgrades to its clients for free.

In the future ahead, ZenQMS aims to enhance its services by focusing more on customers and their requirements, innovation in partnership, reimaging the marketplace, and continuously working on the improvement. Boudouvas notes that initially, he started ZenQMS to do something for an industry that has always been told that their only alternatives are paper/excel, home-grown, outdated software, or expensive and non-user friendly ‘enterprise’ products. “Our platform reinvented the quality management system with an emphasis on customer experience, affordability, collaboration, and access,” he concludes.