SOLUTIONS » Material Management
Pharmaceutical companies need to comply with multiple sets of regulations imposed by various agencies such as FDA, EMEA, EPA, and OSHA. In addition to these regulations, established practices such as cGMP, GLP, and GCP must be followed. The complexity of these guidelines presents a number of adherence difficulties to manufacturers, and increases the compliance requirements placed on them.
Fully 21 CFR Part 11 compliant, Novatek’s Material Management Software Solution is designed to address the industry needs to obtain quality testing within the constraints of production schedules. Compliant with all the aforementioned regulations and practices, it helps companies reduce production time, effort, and resources; altogether preventing 483’s and recalls.
The continuous monitoring and control of incoming raw materials, in-process, and intermediates testing allows companies to identify and control source and manufacturing variations that might influence the final product quality.
Novatek Material Management Features and Benefits
Novatek’s Material Management solution is an integrated module that will assist companies manage their incoming raw materials, in-process materials, and finish goods from registration of the material to final disposition. Material registration is either through the application itself or via interface with ERP systems such as SAP. Some ERP systems have basic material management testing as part of their offerings. The added value of Novatek Material Management system is that it can replace or complement the basic functionality of ERP; making it a complete material management software by bringing statistical analysis and trending for annual product review. The seamless bi-directional communication of your ERP and Novatek Material Management creates a powerful material management system with no duplication of work for the end users.
Novatek Material Management System helps manufacturers maximize operational efficiency while assuring compliance with both internal corporate and regulatory standards. It assists companies bring high quality products to market. It is a fully scalable system designed for corporations of any size. Task management and reporting gives users throughout the facility or corporation appropriate access to input and retrieve data from a single, centralized system. In addition, Novatek’s solutions enable manufacturers to create certificates of analyses for proof of diligence testing quality standards.
With Novatek's Material Management solutions, companies will be able to gain significant control over valuable information needed to comply with federal regulations, bring new products to market quicker, and substantially decrease, if not completely eliminate, product recalls. They also will be able to proactively manage the critical information required to demonstrate regulatory compliance in operating their incoming goods, in- process and finished goods.
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