Compliance & Regulatory
Manufacturing is currently In a mode of accelerated change. Many manufacturing companies face a host of compliance challenges, most of them driven by globalization. More complex supply networks, greater transparency expectations, increasingly strict reporting obligations, and highly vigilant enforcement combine to make regulatory compliance a key issue for manufacturers as well. The situation is not new, just intensifying.
Manufacturers–especially those in the Food & Beverage, Pharmaceutical, and Life Sciences industry–are subject to strict regulatory requirements surrounding electronic record keeping, product traceability, and security. Additionally, many manufacturers in the consumer goods industries must maintain ISO certification to satisfy customers and win new business.
INS solutions offer a variety of features that enhance and support a company’s ability to cost-effectively comply with ISO, FDA and USDA regulatory requirements. The FDA 21 CFR Part 11 regulation was designed to enforce the integrity and security of records that are stored electronically within industries governed by the FDA. The solutions from INS can support the electronic signatures, data security and audit traceability requirements of the FDA. Additionally, they support advanced security policies typically associated with these same requirements.