Novatek International software

A holistic and process-specific risk mitigation system. Nova-Cleaning Validation significantly enhances product integrity by managing changes and assessing the risks associated with cross-contamination and product impurities within a dynamic production environment. All changes to methods, APIs, products, equipment, and family groups are automatically evaluated to ensure product integrity and regulatory compliance. Nova-Cleaning Validation complies with 21 CFR Part 11 and EU Annex 11. The system uses a risk-based approach and is designed based on PDA Technical Reports 29 and 49, ISPE MaPP, 21 CFR Part 211.67.

The Novatek Environmental Monitoring (EM) Software Solution is an industry proven standard with over 20 years of industry use, for managing controlled environments. As a true “Off the Shelf” solution, the core of our Environmental Monitoring software has evolved in response to years of user specifications, and regulatory requirements, through a continuous improvement process. The result is a powerful and compliant solution, designed to evaluate, manage, and reduce the risks associated with everyday Environmental Monitoring.

Monitoring the quality of incoming water and gases is critical for the quality of the finished product. Water is used in several areas of pharmaceutical production (i.e. rinsing, cleaning and a component of the product) and if contaminated can lead to poor quality product. The same applies to gasses used in production. This increases risk of adverse patient reaction from the final product and that may lead to regulatory citations.

Novatek Environmental Monitoring Mobile effectively executes the real-time labeling (barcode), collection, and tracking of environmental monitoring samples in the cleanroom environment. The EM Mobile module is comprised of the software, a rugged wireless tablet PC, wireless barcode scanner, wireless barcode printer and mount that can be used to store and transport sampling media and equipment in the cleanroom. All hardware is cleanroom ready and can be sanitized using standard chemical disinfectants without harming the devices. Our EM Mobile system is integrated with Novatek Environmental Monitoring providing a paperless cleanroom data management system for the entire environmental monitoring process.

Determining of the shelf-life of a pharmaceutical product is critical for understanding how long that product can maintain original quality specifications. Product used after the expiration date can negatively impact a patient. For this reason the shelf-life determination must be accurate. The stability studies required to evaluate shelf-life can take several years to complete. Mistakes made during this process can result in repeating an entire study resulting in long delays getting the product to market.

Pharmaceuticals and regulated industries need to comply with multiple sets of regulations and guidelines imposed by various global regulatory agencies such as FDA, EMEA, EPA, TGA and OSHA. In addition to these regulations, established practices such as cGMP, GLP, 21 CFR Part 11, GAMP and GCP must be followed. The complexity of these guidelines presents a number of adherence difficulties to manufacturers, and increases their overall commitment to compliance.

Nova-LIMS has enabled laboratories to cut back manual and time-consuming activities and has empowered pharmaceutical and biotechnology organizations to achieve objectives such as decreasing product time to market while ensuring regulatory compliance. Over the years, the importance of system integration and automation has drastically increased, thus placing Nova-LIMS at the forefront of process harmonization and data centralization.   Nova-LIMS allows for accountability and reliability between inter-related and interdependent departments.  It provides the entire organization and their respective customers’ seamless integration between laboratory testing, scheduling, data collection, and real-time reporting. Unique to Nova-LIMS is the interface for seamless communication between LIMS and Quality Management Systems.

Calibration and Maintenance is no longer just an overhead expense. It plays a critical role in the success of capital intensive companies in a regulatory environment. The more an organization can maintain and optimize its asset management, the more it can compete in cost effectiveness, quality, delivery time, and new product innovations. Asset management in Regulatory complaint environment is not only important but critical. NOVA-CPM a “best in class” calibration and preventive maintenance software, is a proven solution that helps organizations optimize their calibration processes and manage their assets in an FDA regulatory compliant environment.

Novatek`s Quality Management System, Nova-QMS, is a comprehensive solution designed to address pharmaceutical & biotech companies; most pressing quality issues including documentation, corrective and preventive action procedures, production validation, metrics and traceability. Nova-QMS is a process-driven application comprised of integrated modules such as document, audit, and training management, CAPA, change control, incidents and deviations management, complaint management and investigation. The modules can be purchased separately or all together and integrated. Nova-QMS enables organizations to increase efficiencies and achieve compliance by integrating related events and actions, streamlining workflow, and facilitating trending and reporting across all quality systems.

Novatek’s Validation Management software creates a roadmap for validation practices that goes beyond customer processes, and promotes unified data views across any organization.