Part 11

BPA provides a full range of services to assist you in meeting the 21 CFR Part 11 requirements. BPA has developed a five-step compliance process that spans from gaining management approval to achieving compliance of specific systems.

Services

The services BPA offers for each the 5 phases include:

Gaining Management Approval

• Educating management on the Part 11 regulation and the 5-step process to compliance
• Advising you on gaining management buy-in
• Preparing a corporate Part 11 compliance and validation policy

Developing an Inventory of Part 11 Systems

• Working with you to prepare an inventory of Part 11 systems

Preparing a Compliance Master Plan

• Classifying the Part 11 systems according to priority categories
• Preparing a Compliance Master Plan

Creating a Compliance Infrastructure

• Preparing policies and procedures for: Part 11 compliance, validation, metrology, risk management, and IT processes (such documentation can also be purchased from BPA)
• Implementing the infrastructure, including training

Achieving Part 11 Compliance of Individual Systems

• Managing the compliance project
• Evaluating the system’s compliance with each Part 11 clause
• Performing a risk assessment as a basis for appropriate remediation
• Identifying and implementing appropriate risk based remediations
  • Customizing the software to build in Part 11 functionality, if appropriate
• Training employees on computer system validation
• Validating the system

Training

• “Implementing Part 11”
• “Part 11 Overview for Software Developers”
• “Computer System Validation for Business Applications”
• “Execution of Validation Protocols”

Benefits of Our Services

BPA will work with you to develop and implement a compliance program that:

• Is built on an infrastructure of policy and procedures
• Achieves compliance through a documented master plan that addresses system priorities
• Manages the risks associated with potential system failure
• Keeps remediation expenses commensurate with the value obtained

Part 11 compliant, validated systems will:

• Function reliably to meet requirements
• Ensure record trustworthiness and reliability
• Safeguard product quality and safety