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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

  • Supply chain disruptions
  • Workforce training
  • Storage of huge amounts of data
  • Analysis of huge amounts of data
  • Lack of agility and transparency

Problems Faced

Quality Problems

  • Manual paper-based change control procedures are prone to errors. Maintaining manual CAPA register and controlling CAPA form issuance and reconciliation is labour intensive. Extensive manual follow-up is required to determine status and ensure the CAPA is progressing. Tracking the due date of quality events is challenging due to lack of control mechanisms. If quality event procedures are not implemented in a timely manner, it will have an adverse impact on the product quality
  • For pharmaceutical industries good documentation practices is one of the GMP requirements. Manual preparation of documents is a time and manpower intensive task. It takes 4 hours on average to prepare a batch record and 16 hours on average for issuance of production records. Manual document management may result in loss of critical documents, wrong filing and mislabelling. Tracking all available versions of a document is challenging. There is also a high scope of missing signatures, which results in audit observations. Additionally, in a paper-based system, documents are stores in shelves, which requires expenditure on storage and security
  • 448 Warning letters have been issued to the medical devices industry in the past 5 years. An increase in the warning letters results in increased approval timelines, as well as loss of reputation
  • Clinical research is a complex process that necessitates the collaboration of multiple teams with varying levels of expertise and experience to carry out various tasks. Comprehensive administrative work is needed to compile the data across the clinical trials. Extensive recruitment is required to reduce the burden on senior trial leaders. Data should be captured from multiple sources, which may result in duplicate entry of data. There is no single source of data for information retrieval. With manual procedures data consistency between different sources cannot be achieved

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

  • R&D captures experiment data in hardcopy note books, which makes it difficult to search for and archive information. It also increases dependency on individuals to conduct the experiment. The paper based-system leads to high amounts of information loss and reduced efficiencies due to duplication
  • Pharmaceutical QC laboratory requires a strict adherence to SOPs and regulatory compliance. Without digitalization, maintaining complex workflows and sample tracking becomes difficult. Managing the complex data by using manual analyses methods can sometimes lead to errors. Tracking of equipment maintenance schedules and keeping all equipment calibrated is complicated. Ensuring timely communication between all stakeholders of an experiment is challenging
  • To get Marketing authorization, pharmaceutical companies have to submit dossiers to regulatory authorities (CDSCO, FDA, EMEA etc.). Regulations undergo changes, sometimes after multiple years. To comply with the updated regulations, the products also need to be modified and resubmitted. However, it is difficult to retrieve the product related information from paper-based records. Different regulatory agencies have different requirements, and complying with all of them becomes virtually impossible using paper-based methods

How A.i.zen Algo Pvt. Ltd. can Help

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.

Our Products Deployed in industry


Document Management System

Smart, interactive and predictive framework Know More


Quality Management System

Intelligent quality system that ensures compliance Know More


Training Management System

AI enabled, comprehensive learning ecosystem Know More


Audit Management System

AI/ML enabled system for 24x7 audit readiness Know More

ReguZen™ (Coming Soon)

Regulatory Info Management System

Intelligent, holistic dossier filing system Know More

ClinZen™(Coming Soon)

Clinical Automation

Automated end-to-end clinical workflow Know More

NoteZen™(Coming Soon)

Electronic Lab Notebook

Smart, interactive and intuitive lab notebook Know More

LabZen™(Coming Soon)

Laboratory Info Management System

Automated, ML enabled laboratory workbench solution Know More

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