Validation Process and Compliance Support with IBM Maximo Asset Management in Regulated Industries
Organizations in life sciences, biologics, healthcare products, food, and certain consumer products industries are responsible for ensuring that their products are manufactured and distributed in conformity with governmental and industry requirements and specifications. While there is no single method to guarantee software compliance, IBM Maximo® Asset Management can provide e-signature and e-record (audit trail) capabilities that support efforts to comply with regulations and guidelines related to e-records and e-signatures. It can also provide support for European Union (EU) Directive 91/356; the International Conference on Harmonization (ICH) Q7A guidelines for active pharmaceutical ingredients in the EU, the United States, and Japan; and the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) guidance on pharmaceutical inspections. Maximo Asset Management Control can also provide tracking and enforcement of system logins.