Pharmaceutical businesses study ailments, conduct research, and develop new treatments and medicines to treat them. Patients and healthcare providers (doctors, nurses, hospitals, nursing homes, clinics, etc.) rely on these industries for disease treatment.
With ZenVector™, the industry can take care of the following challenges
Quality Problems
Manufacturing Problems
In 2015, 30 percent of the 40 GMP warning letters issued by the FDA for data integrity deficiencies referenced training issues or requirements. As the FDA continues to approve new drugs faster than ever before, and with the changing regulations, employees need to be trained on specific topics and tools to get quality production. It's critical to provide not just an onboarding training programme, but a full year of training for employees that incorporates daily, monthly, and quarterly blended learning experiences.
R&D Problems
Quality Management System for Pharmaceuticals
QualZen™ enables pharmaceuticals industry users to manage all the quality events on a digital platform, including initiation and managing the workflows. For deadlines, notifications are sent to individuals, and escalation mechanisms are created in case of delays. Its intuitive workflow allows users of pharma companies to investigate the quality event and enable review by peers. The dynamic dashboards empower the management to visualize the ongoing, pending and completed quality events, to produce defect-free, good quality safe products, which are in compliance with the specifications of the pharma industry.
Document Management System for Pharmaceuticals
DocuZen™ enables a better control over document versions and changes. It empowers the authors in the pharmaceuticals industry to create the document, engage with other authors across the globe, and then put the document through global peer review workflow. It sends automated notifications for review to users. The document can be made available to all users once is it peer-approved. It makes the documents easily searchable through keywords. The integrated editor enables users to create the document within the application. DocuZen™ reduces the batch record preparation time to 2 hours, and production record issuance time to 6 hours.
Audit Management System for Pharmaceuticals
AuditZen™ effectively manages all the warning letters information (Observations & Responses) of the clients in the pharmaceuticals industry. There is a complete audit trail of each step, keeping the organization 100% audit ready. During internal audits auditors can focus on the existing observations to avoid the repetition of same ones.
Clinical Protocol Automation for Pharmaceuticals
ClinZen™ ensures that data generated across the lifecycle of a clinical trial is captured in a single platform. It effectively manages the trial subject’s data with end-to-end trail. It eliminates the possibility of duplicate data entry. Management and study directors can effectively track the data and any information about any clinical trial. ClinZen™ makes all data regarding resources available in the system itself. It helps the pharmaceuticals industry to maintain transparency in clinical trials across various sites and collaborators.
Training Management System for Pharmaceuticals
EduZen™ provides training to employees of the pharmaceutical industry on company specific documents. Only those who qualify are assigned tasks, resulting in quality production and GXP compliance for the pharma companies. Group leaders/HODs can create training groups and assign employees in specific groups. Annual training calendar can be prepared wherein all documents on which training is required can be mapped month-wise. EduZen™ enables deadline notifications and search feature to find qualified employees. Reports can be generated using keywords, and real-time dashboards enable the management to perform a complete analysis of their workforce.
eLab Notebook for Pharmaceuticals
NoteZen™ enables procedural execution, automation of manual processes, collection of instrument data, calculations, limit checking, calibration checking, and inventory checking and updating. One can effectively design and plan the experiments inside NoteZen™. Users have the freedom to use preconfigured experimental templates through cloned previous experiments, or to start from scratch. NoteZen™ supports visualization of entire lifecycle of project and experiments. It enables pharmaceuticals industry users to easily search the experiments by giving keywords and download the reports if required. In NoteZen™, experiments are structurally arranged in folders & the users can even collaborate with others globally.
Laboratory Information Management System for Pharmaceuticals
LabZen™ enables pharma companies to easily track the raw materials and samples used in batch execution, and results can be effectively managed against specifications, along with automated approval. All the tests performed on the batch at every stage can be managed, providing a complete end to end laboratory workflow management. LabZen™ ensures automatic rejection of tests if the values do not fall in the specified range. The users can effectively plan the tests using the inventory management feature.
Regulatory Information Management System for Pharmaceuticals
In ReguZen™, the entire dossier lifecycle can be effectively managed. Using the real-time dashboards, management can visualize the number of products submitted to any particular regulatory agency. One can find out the number of products completed, pending and under review by regulatory agencies. ReguZen™ enables storing the product related queries raised by agencies and respective responses given by the internal team. Responses submitted for queries can undergo review and approval by respective leads. If any queries are near their due date, system will send notifications to respective members. ReguZen™ ensures the client gets market approval faster by submitting responses within timelines.
