Below is a preview of the introduction of PSC Software’s first White Paper. To read the rest of the White Paper contact us here!
Inspections are on the rise. There are a variety of reasons for this trend, ranging from specific industry trends (such as ISO certification) to globalization of the industry. Additionally, the development of counterfeit products has risen sharply, and following the Heparin catastrophe, the concern for animal-derived materials has become of paramount concern in the biotech arena. Companies are seeking to achieve a competitive advantage through accreditation, and regulatory inspections have become more frequent and more comprehensive. Developing countries that in the past have relied upon FDA and EU licensure are now sending their inspectors out on international inspections.To give you a good idea of what the rest of the White Paper will be about, read the summary below.
Abstract: Global clarification and escalation of pharmaceutical regulations has resulted in increasingly complex audits. Audits today are more frequent, longer in duration, and deeper in scope, which results in amplified challenges for effective audit management. The outcome of the audit is often influenced by the firm’s ability to effectively manage the audit. The present study evaluates the nature of current audits and details a critical aspect of efficient audit management; the automated control, sorting, presentation, and organization of document requests through a real-time inspection management software database, Audit Utopia TM.