ZenQMS
Eliminating Paper-based Compliance Management with Better eQMS Tools

Panos Boudouvas, Co-founder and CEO of ZenQMS, encountered the complexities caused by paper-driven compliance systems early in his career. “All of our sites were struggling with paper or homegrown tools for managing SOP’s, audit responses, CAPA’s, etc. We had people circling the plant looking for signatures. We were running out of space for our paper files. And we had excel spread sheets that needed to run on a super computer to keep track of document versions and training records for every employee. Reporting and analytics was a nightmare, as was retrieving documents. It is a compliance red flag for all external clients and regulators, which put us at an increased risk of failure,”says Boudouvas. “Most companies are forced to stay in paper-based systems due to the cost and complexity of existing 'solutions' that dominate the market. So we created a QMS for the other 95 percent of the market that has been left behind.” Boudouvas founded ZenQMS to address these problems with an easy-to-implement, affordable quality management solution for regulated industries.

"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.

ZenQMS accounts include modules for Document Management, Issue Investigation/CAPA Management, Training, Audits and Supplier Qualification; all of which are supported with compliant electronic signatures. ZenQMS is a pure Software-as-a- Service application, so clients only need a browser and active internet connection to get started immediately. The platform is fully validated for compliance to regulatory requirements for key industries (e.g. pharmaceuticals), meaning clients can avoid the costs and delays associated with the traditional approach to software deployment.

Pricing remains a key differentiator for the company. “Affordability and transparent pricing were part of our founding principles. There are no user seat licenses or costs for storage—you pay based on what is in your account. So getting started with ZenQMS doesn't require a lot of money or resources," remarked Boudouvas.

Key attributes of the ZenQMS platform include:

• Documents: Upload Standard Operating Procedures (SOP), work instructions, policies, general documents and even training videos in one place. All documents are maintained in a traditional document lifecycle with features like keyword search built in. There are no restrictions on file type or size.
• Training/Learning Management: Assign training content from the Documents section to any user or group instantly. Assignments are immediately posted to a user’s dossier, triggering alerts as necessary. Courses and personal events can also be created. “The days of wrong or inaccurate training files are gone", says Boudouvas.
• Issue Investigations/CAPA’s: Log an issue of any type (e.g. Deviation or Change Control), and allow your team to execute a traditional evaluation and remediation process. Related corrective or preventive actions can be assigned to any employee and even shared with external partners.
• Audits & Supplier Management: Log all external supplier qualification activities and record all internal, client or regulatory audits and related observations in one place.
• External Collaboration: Connect directly with external partners to complete audits, log deviations for investigation, etc.

“We set off to do something amazing for an industry that has been told that their only alternatives are paper/excel, home-grown software or outdated, expensive and non-user friendly ‘enterprise’ products,” states Boudouvas. “Our platform reinvented the quality management system with an emphasis on customer experience, affordability, collaboration and access,” he concludes.