Ready to use prioritized GxP requirements, to:
Interface so that your team is responsible for maintaining Quality Assurance Systems/affiliate quality management system to ensure compliance with organization standards and regulatory guidelines. .
- How does data enter the system and how it is ultimately consumed?
- What does who data integrity and good data and record management expect?
- Is raw data in the system considered an electronic record and handled/retained accordingly?
- Which decision does the data influence?
- Does your supplier have a data integrity policy?
- How much previous data will you need to review?
- Do changes to the Data Backups process follow a formal change control process?
- Does the AMP identify the key systems holding data used in the asset management process?
- How has your organization ensured its asset management information system is relevant to its needs?
- Does normal operation or control of the sub system have a direct affect on product quality?
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