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Data Integrity e-Learning Suite
FDA guidelines1 state that personnel must be trained ‘to prevent and detect data integrity issues.’ Inadequate training of personnel, however, creates a ‘knowledge gap’ that increases your organization’s risk of regulatory non-compliance!
Skillpad’s data integrity e-Lessons are designed to bridge this knowledge gap. Covering the essentials of data integrity, including audit trails, they feature realistic scenarios that challenge users to make critical data integrity decisions. Numerous examples of common data integrity failings are presented along with relevant regulatory requirements and expectations.
Suitable for both onboarding and as part of annual refresher training, the e-Lessons are deployable on any LMS and can be tailored to your company’s exact requirements.
1FDA Guidance for Industry: Data Integrity and Compliance with cGMP
KEYWORDS
- ALCOA+
- Records
- Data Integrity
- Compliance
- 21 CFR Part 11
- Personal Responsibility
- Audit Trails
- GXP