PRODUCTS

Compliance and Validation encompass a variety of activities, and produce several deliverables. Following are some of the deliverables Fuller Compliance can provide your business. Your deliverables can and will be customized to your corporate system.

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  • Validation Master Plan (More Info)
    • The Validation Master Plan is the foundation for your entire 21 CFR Part 11 and validation efforts. It becomes a road map for company and FDA personnel.
  • Software Validation Master Plan (More Info)
    • A well-developed Software Validation Master Plan will include provision for identifying and validating all regulated computer software.
  • Automation Systems Validation Master Plan
    • A well-developed Automation Validation Master Plan will include provisions for 21 CFR Part 11 compliance and validating all regulated automation systems.
  • Validation Deliverables
    • Deliverables must be customized to integrate with current or planned validation strategy. We have delivered as many as sixteen deliverables per software package.

Validation Master Plan
Your custom Validation Master Plan will provide the following:

  • Guide company personnel in validation activities
  • Demonstrate to FDA personnel company's commitment to action
  • Satisfy other stakeholders of company's commitment to quality
  • Address 21 CFR Part 11 gaps

Software Validation Master Plan
The Software Validation Master Plan is the heart of your software compliance activities. Your custom SVMP will provide the following:

  • Provide specific direction to company personnel, resulting in consistent and timely validations
  • Demonstrate to FDA personnel your company is making good-faith progress in bringing all systems into compliance
  • Fuller Compliance provides Software Validation Master Plans to include:
    • Software Inventory
    • Prioritization of software packages
    • Level of effort setting
    • Proposed schedule, staffing and budgets
    • 21 CFR Part 11 Electronic Records / Electronic Signatures compliance

Automation Master Plan
The Automation Master Plan is the heart of controlling your manufacturing automation.
Your custom Automation Master Plan will provide the following:

  • Provide specific direction to company personnel, resulting in consistent and timely validations.
  • Demonstrate to FDA personnel that company is in process of bringing all automated systems into compliance with validation regulations.
  • Allows company to minimize down-time, shorten the time to implementation of a new automation system and save capital resources in the process.
  • Fuller Compliance provides Automation Master Plans to include:
    • System and Software Inventory
    • Prioritization of systems (risk-based)
    • Level of Effort setting (based on priority)
    • Proposed schedule, staffing and budget
    • Ensuring 21 CFR Part 11 compliance

Validation Deliverables
Deliverables must be customized to integrate with current or planned validation strategy. We have delivered as many as sixteen deliverables per software package. Your deliverables package will be customized to conform with your software development life cycle (SDLC), your SOPs and other elements of your business process.

Deliverables
Various philosophies govern the practice of software validation. Many companies want as many as thirty (30) deliverables per software or system. Others may want only the minimum. We can tailor your deliverable set to meet the needs of your staff, or the demands of FDA field or enforcement personnel, internal and external auditors, or (if you are a supplier to a regulated entity) your customer.

  • Validation Plan
    • The Validation Plan is the foundation for your validation effort on each software or system. It becomes a road map for both your company and FDA personnel.
  • Requirements Traceability Matrix
    • The Requirements Traceability Matrix ensures that all requirements are tested, and all test cases relate to a particular requirement or design element. A well-developed Software Validation Plan will include provision for identifying and verifying testing all requirements.
  • Requirements
    • The FDA's regulations call for the regulated business to validate software used in the manufacture of a regulated drug or device to the manufacturer's intended use. The requirements document is the vehicle for capturing the intended use. As such, it forms the foundation of the validation effort.
  • Protocol / Test Cases
    • The requirements are then tested, using pre-planned test cases, with explicit pass/fail criteria.
  • Reports
    • In many instances, only one report is generated at the end of all validation action. In the case of more complex software or systems, interim reports may be generated. In particular, if separate Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing are performed, separate reports provide greater insight into the goals and outcomes of testing.
  • Change Control
    • The software can only be considered "validated" so long as it has not been changed. The need for solid change control strategy and implementation cannot be over-emphasized.