The Stability module is a software application that manages the day-to-day activities of the stability department within the quality control and/or R&D divisions. Its design takes into consideration the latest guidelines from the FDA, TPP, ICH and EU, among others, pertaining to pharmaceutical, chemical, biological and biotechnological fields. This software is designed for all types of products, from pre-clinical to post market, innovator or generic. The Stability module is 21 CFR part 11 compliant and has an extensive, independent audit trail.

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The Finished Product Analyzer module is a software application that is used for capturing the test data from finished product testing. This application consists of Product Registration, where the user can input pertinent information regarding the product and the type of packaging; Monograph, where the user can define the required tests; Certificate of Analysis: used for entering, verifying and approving the data; The Approved manufacturers and Suppliers list; where the user verifies that the product is from an approved source; Investigation; where the user can initiate an Out of Specification Investigation. The trending of lots is possible to ensure that the process is under control. The Finished Product module is also 21 CFR part 11 compliant and has an extensive, independent audit trail.

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The Raw Material Analyzer module is a software application that is used to facilitate the testing of Raw materials and incoming Packaging components. The Software consists of the following windows: Product Registration, where the user can input pertinent information regarding the product and the type of packaging used in shipment of the Raw Materials; Monograph, where the user can define the required tests; Certificate of Analysis: used for entering, verifying and approving the data; The Approved manufacturers and Suppliers list; where the user can verify that the product is from an approved source; Investigation; where the user can initiate an Out of Specification Investigation. The trending of lots is possible to ensure that the raw material manufacturing process is under control. The Raw Material module is 21 CFR part 11 compliant and has an extensive, independent audit trail.

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The Preventive Maintenance and Calibration (PMC) module is a software application that is used to track the status of equipments used in a regulated environment. The software allows the registration of the equipment, the definition of the required tests to ensure the equipments are within the specifications and a test report where the user can enter the obtained results. The software will automatically show the equipments due for calibration. The inventory control window allows the purchase and update of the required spare parts for each calibration. The PMC module is also 21 CFR part 11 compliant and has an extensive, independent audit trail.

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The Automated Packaging Component Analyzer (APCA) module is an application used to automatically verify the incoming printed components against a pre-approved master. This software is language independent and capable of detecting the smallest error within the test and the master scans. It is capable of analyzing a predefined number of samples against the master and providing the error in each and every test sample. The user will have the choice to accept or reject the printed components based on the type of errors obtained. The APCA is envisioned to replace the tedious task of manually verifying a printed component against the master. The APCA module is, once again, 21 CFR part 11 compliant and has an extensive, independent audit trail.

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Environmental Monitoring Program is an application capable of capturing all environmental data in a 21 CFR Part 11 Compliant, fully validated system. It is envisioned for sterile and non sterile health care industries (Pharmaceuticals, Biotech, Chemical, microbiological) food and any other sterile environment based on the latest guidelines from, FDA, EU, ISO 14644-1 and PDA Technical report 13.

Data from viable and non viable monitoring, Water analysis, clean steam and compressed gases are securely captured and easily trended to ensure site "state of control". The investigation window allows the user to investigate Out of Specification "OOS" with capability to add any files such as picture, audio video, scanned documents etc to the report.

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Document Management System Module:
This module is a complete, innovative and secure document management system with full text searching/indexing capabilities. Documents are tracked and stored in the system, encouraging collaboration, while disallowing un-audited access or changes to the documents. The system is used for all types of documents, such as SOPs, Change Controls, Investigation Reports, Temporary Deviations, Batch Records, Validation documents, Protocols, Reports etc.

D.A.T.A. will enable inter / intra-facility paperless communication, reviews, approvals, and release through a sophisticated system with e-mail notifications, multi-level security, and multiple user authorities.

Audit Management Module:
Manages and records all activities associated with internal and external audits. Once an audit is registered in the system, users are notified by e-mail when completions, reviews and approvals are required or entered, when deadlines are impending, or when specified tasks are outstanding.

Personnel Training Management Module:
This module is used to manage the training/re-training schedules of personnel, and to create and manage tests to assist with or determine retraining needs. Users can take pre-registered tests over the company intranet or via the software interface; the results of the test are automatically calculated and stored in the database for later retrieval.

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Novatek’s Consumable Management Software (CMS) is a 21 CFR part 11 compliant, comprehensive inventory management system. It allows management of purchase orders, receivables, inventory locations, transfers, and serialized item tracking. Each material item in the price book has corresponding inventory details that can show all purchases, sales, quantities on hand, quantities reserved, quantities at each physical location, and the latest costs and values. The strength of the product lies in its non-modular design that enables you to enhance your business productivity significantly without ever having to add separate software. With Novatek’s CIMS, you get a powerful yet affordable 'mini-ERP' solution right-out-of-the-box!

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