Design Level Validation

META Solutions’ design-level validation services enable software vendors to implement an effective validation and compliance strategy that meets FDA and life sciences industry expectations and requirements. Our design-level validation suite of services covers design, development, testing, quality assurance, and deployment activities. META Solutions has helped dozens of software developers prepare for and pass customer audits for pharmaceutical, biotechnology, CRO, and medical device manufacturing companies.

Software Vendor Responsibility

Computer Systems Validation is required by 21 CFR Part 11 (“Electronic Records Electronic Signatures”) and for critical pharmaceutical, biotechnology, and medical device software applications and services. Design-Level Validation is that portion of the software validation process that is performed before the product is delivered to the end user.

Design-Level Validation includes all design, development, testing, training, quality assurance, and deployment activities. As stated in current FDA guidance documents, your customer is responsible for evaluating your design-level validation activities (preferably by performing a reliable vendor audit) to determine conformance of your product to regulations and contemporary standards.

META Solutions can help you to achieve and maintain contemporary standards and prepare for customer audits through our suite of design-level validation consulting services. We have successfully performed these services for dozens of software vendors and service providers, as well as their customers. Our Design-Level Validation Consulting Services are designed to help you develop an effective validation strategy that can be efficiently implemented to meet local regulatory and industry expectations.

Design-Level Strategy Development

META Solutions will develop a strategic plan to maximize compliance of your Design-Level Validation processes to regulatory requirements and expectations. This activity will involve the following:

  • Reviewing company SOPs and development, testing, training, quality assurance, and support documentation. The review will focus on your processes to ensure that your system functions according to established requirements and that data are processed accurately and in compliance with applicable regulations.
  • Identifying new documentation that should be developed, existing documentation that requires enhancement, and other activities that should be considered.
  • Developing a “Design-Level Validation strategy” document, a detailed plan (e.g., activities, roles and responsibilities, milestones, schedule, dependencies) to help you ensure that the system is compliant with regulatory requirements and expectations. This document would serve as a “read me first” document for auditors.

Design-Level Strategy Implementation

META Solutions can help implement your Design-Level Validation strategy by assisting in any or all of the following:

  • Developing a formal “Functional Specification” to describe the predetermined requirements and quality attributes that the system is expected to meet, and provide details of what the system is designed to do.
  • Developing a formal “Design Specification” to provide details regarding how your software will meet the pre-determined system requirements.
  • Developing a formal “Traceability” from system requirements to functional specifications, functional specifications to technical specifications and test cases to functional/technical specifications.
  • Developing formal “Test Protocols” and “Test Scripts” for all phases of testing (e.g., module, integration, system, functional). We can also execute tests and document test results according to formal testing standards and regulatory expectations.
  • Developing user, technical and operational documentation for use by system users and support personnel.
  • Developing and delivering regulatory training to your development and support staff.

SOP Development

META Solutions can develop policies and procedures that your customer would expect to see during an audit. These could include, but are not limited to, the following:

  • Validation Requirements
  • System Development Methodology Requirements
  • Installation Qualification (IQ) Requirements
  • Operational Qualification (OQ) Requirements
  • Performance Qualification (PQ) Requirements
  • Testing Standards
  • Hardware Maintenance
  • Physical and Logical Security
  • Change Control
  • Backup and Recovery
  • Disaster Recovery (Contingency) Plan
  • Quality Assurance
  • Archiving
  • Re-Validation
  • Training

Representative Projects

CRO Clinical Data Management System Validation
Validation of a data management system was performed in conjunction with our validation department for a small CRO. A detailed knowledge of the data management process was needed to determine whether the client was in compliance with established guidelines and regulations. This was a retroactive validation of a system that was already in use.

Health Care Delivery System Validation Strategy
Developed a testing and quality assurance strategy to assist a global pharmaceutical company in the development and deployment of a knowledge-based health care delivery system. This assistance also evolved into on-going audit and assessment activities covering the development, testing and documentation of the various phases and versions of the respective system.

Toxicology System Validation Consulting
Provided consultation to a large Canadian contract toxicology laboratory regarding the development of a comprehensive, integrated toxicology data management, project management, and study reporting system. The consultation included review and evaluation of the proposed development methodology, software development SOPs and system design documentation, and interviews with affected personnel.

Evaluation of Validation Status
Evaluated the validation status of existing validation documentation for a major toxicology data acquisition and management system. The objective was to identify specific business and regulatory risks and recommend practical solutions to mitigate the risks.

META Solutions applies its expertise in a practical and logical way to help companies worldwide. We continually strive for innovation and we share our principles and practices through training, presenting, and publishing. We develop services and creative offerings that provide new and more efficient ways for our customers and their vendors, suppliers, and service providers to conduct their business both within regulatory compliance and with reduced risk. We are prepared to achieve the same results for you.