We share how to get the most out of documenting your quality management system that can also help you stick to ISO 9001 standards.
While all enterprise software implementations are unique we share six best practices that will improve the likelihood of any successful quality management software implementation project.
In this blog we highlight the history and purpose of a document management system and look into the future with cloud-based electronic document software.
Review three biopharma contract manufacturing trends that are indicators of exciting industry developments and also reveal areas that are ripe for change.
We share some SOP guidelines that can help you build and manage documents that are easily accessible, relevant, and something your team can consistently rely upon.
While CSV can be a pain to deal with, it is necessary. Explore our eight best practices that can reduce validation time to a matter of hours or minutes.
Explore the relationship between FDA predicate rules and GMP, GLP, GCP, or other requirements applicable to your organization.
Learn how to significantly lighten the software validation load for your cloud environment system with these eight key practices.
Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.
Learn why time is of the essence when crafting a FDA response letter and remediation plan as well as the best practices for responding.
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