New software to aid FDA compliance

The new product, 'FDA Validation Workbench', includes software to help companies monitor their adherence to a variety of FDA regulations and requirements regarding processing, safety and tracking. The package includes software for tracking and managing validation activities, templates for completing documentation required by the FDA and consulting services to assist manufacturers in completing the validation process, among other features. "This product directly addresses one of the most difficult and time-consuming problems faced by life sciences manufacturers,"​ said Fullscope president Russell Smith. "Until now, products targeting this issue have been expensive, complicated and cumbersome. With the new FDA Validation Workbench, a pharmaceutical manufacturer or other life science company can quickly and cost-effectively navigate the complicated validation process." ​ With the consequences of failing an FDA inspection impacting on a company's reputation as well its pocket, keeping up to speed with agency requirements is a necessity in terms of a successful business, not to mention the implications for patient safety and consumer confidence. The product offered by Fullscope includes templates for a validation master plan, a supplier audit check list, validation standard operating procedures, disaster recovery and a validation summary report, as well as a number of other templates. According to the company, this latest product complements other software solutions available from the firm, such as the supply chain management solution product, 'Process Industries for Microsoft Dynamics AX'. Fullscope is a participant in the Microsoft Business Solutions Industry Builder program, whereby Microsoft markets software solutions developed by independent vendors. Fullscope developed the process industries program for Microsoft Dynamics, which can be applied to the life sciences and pharmaceutical sectors and aid firms with a variety of business management and regulatory issues. According to the company, the process industries software can help optimize manufacturing resources, support good manufacturing practices and regulatory compliance and also help improve production planning and inventory management. The company itself aims to assist mid-market manufacturers to find a successful balance between customer service and operational performance objectives. By providing a software solution that could help take some of the hassle out of the time-consuming job of ensuring FDA validation, the Fullscope product could be well worth the investment given the potential consequences of failing to comply with agency requirements.