"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.
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amazing for an industry that has been told that their only alternatives are paper/excel, home-grown software or outdated, expensive and non-user friendly ‘enterprise’ products,” states Boudouvas.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.