Modernizing quality management and collaboration in pharma systems validation
Good Automated Manufacturing Practice (GAMP) is a set of guidelines that ensure the quality, safety, and efficacy of pharmaceutical products. Digitalizing GAMP systems validation over paper-based document management in pharma offers numerous benefits.
Paper-based documents can be misplaced, lost, or damaged. GAMP systems provide a secure, centralized platform for all validation documents to be stored, accessed, and easily tracked. GAMP also enables real-time collaboration among teams regardless of their geographical locations, which is key for remote teams, making communication, review, and approval processes possible for faster validation cycles.
Pharma is highly regulated, and compliance is crucial. GAMP allows for better compliance management, automated tracking of changes, version control, and audit trails. All validation activities are documented and easily retrieved during regulatory inspections.
Going paperless cuts down on printing, storing, and management costs of physical documents, also eliminating the need for manual data entry and reducing the risk of transcription errors. GAMP systems can also generate reports and analytics that provide valuable insights for areas of improvement and cost optimization.
Protecting intellectual property and personal patient data is of critical importance for pharma. GAMP offers robust data security measures, such as encryption and access controls so that sensitive information remains confidential.
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