Making MS Access Part 11 Compliant: Tools and Techniques management report explains how to use MS Access to build powerful and compliant electronic records systems. From lab records to clinical trial data, you’ll learn effective validation tactics for ensuring the authenticity and integrity of your records and your systems. Plus, you’ll know how to implement today’s best technical and procedural controls for collecting, processing and reporting information.

In one source, you'll cover all the Part 11 compliance angles, including:

• Technical controls — from audit trails and electronic signatures to inactivity timers, event logging, and passwords
• Security — how to protect data and close common security gaps in MS Access programs
• Procedural controls — including SOP generation and training
• Policies — what must be covered for electronic signatures
• Validation — step by step with MS Access programs
• Information exchange — preparing data for electronic submissions … sending certification requirements to the FDA
• Regulatory guidance — understanding the ramifications of Part 11 guidance documents
• Audits — how to provide electronic records and signatures