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.
Novatek’s Material Management solution is an integrated module that will efficiently assist organizations manage their incoming raw materials, in-process materials, and finish goods from initial registration of the material to its final product.
Novatek Material Management System helps manufacturers maximize operational efficiency while assuring compliance with both internal corporate and external regulatory standards. It assists companies to successfully manufacture high quality products to market. It is a fully scalable system designed for organizations of any size. Task management and reporting gives users throughout the facility or organization appropriate access to input and retrieve data from a single, centralized system. In addition, Novatek’s Material Management software enables manufacturers to create certificates of analyses.
Material registration in Novatek’s Material Management software is conducted either through the application itself or via an interface with ERP systems such as SAP. Some ERP systems have basic material management testing as part of their offerings however the added value of Novatek’s Material Management software is that it can replace or complement the basic functionality of an ERP system, making it an extensive and complete application bringing together both statistical analysis and trending for annual product reviews. The seamless cross functional communication of an ERP system and Novatek’s Material Management software creates a powerful operating system that performs with minimal repetition of work for its end users.
With Novatek’s Material Management software, organizations 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.
FEATURES & FUNCTIONS
- Certificate of Analysis
- Material status & assignments
- Skip lot testing
- Validated automated calculations
- Trending & reporting
- Approved supplier management
- Rapid material release
- Creates inter-departmental visibility & enhance planning
- Minimizes inventory investments & expedite material turnover
- Instils efficiency in all activities
- Annual product review
- Centralizes inventory & material management data