Testing and 21 CFR / Validation

testing

Outages in applications that run your enterprise can at best be embarrassing; at worst, they can cripple. Today, businesses demand quick delivery, constant feature enhancements, and a high level of confidence in the quality of their software, at a price that is not just economical but also highly profitable.

Independent Testing is the process of ensuring the quality, interoperability and usability of products, applications, systems and web sites. It brings a fresh perspective and an unbiased opinion on issues of software problems and risks.

Infosys’ independent testing solutions involve rigorous verification and validation methodologies that reduce defects in every stage of the System Development Life Cycle (SDLC). These are achieved through Return on Investment (ROI) -based verification and validation strategies, and risk-based test effort optimization.

Our independent testing solutions ensure:

  • Increased productivity through automation
  • Enhanced delivery confidence
  • Predictable time to market
  • Lowered cost of ownership
  • 21 CFR/ VALIDATION

Validation

ILOGTEK is a global provider of clinical development, regulatory/validation consulting and medical communications services to the pharmaceutical and biotechnology industries.

Monitoring and consistently applying FDA regulations is not an easy task. ILOGTEK performs a number of services that will allow you to keep your applications in compliance with FDA regulations, and will keep you abreast of the latest developments in regulatory compliance.

21 CFR Part 11 Assessments

ILOGTEK can perform a complete 21 CFR Part 11 assessment of your systems environment, identifying compliance gaps, developing a plan to bring your applications into compliance, and assisting with remediation efforts. We also offer a course to train your staff on 21 CFR Part 11 requirements.

Assuring compliance with 21 CFR Part 11 regulations requires examination and evaluation across systems, products, processes and functions within your organization. ILOGTEK has the perspective, objectivity, experience, expertise and services to help ensure your company’s compliance.

Strategic Planning

ILOGTEK helps companies develop strategic plans for complying with 21 CFR Part 11 by:

Providing regulatory requirements and applicable guidance policy training to

  • Pre-Clinical and Clinical Research
  • Clinical Data Management
  • Regulatory Affairs
  • Information Services
  • Software Development
  • Quality Assurance personnel

Identifying the specific systems that fall under the scope of 21 CFR Part 11 and evaluating the potential regulatory issues for each

Determining if existing policies and procedures are consistent with, and conducive to, developing and deploying 21 CFR Part 11 compliant systems

Developing a remediation plan to address regulatory issues:

  • stratification of systems according to risk
  • identification of specific system issues and corrective measures
  • establishment of roles and responsibilities
  • determination of resource requirements
  • creation of milestones and target dates.
  • Regulatory Auditing

ILOGTEK audits help clients identify their specific areas of risk regarding 21 CFR Part 11 compliance of systems, procedures, documentation and controls. During the audits, we review applicable documentation, interview key quality assurance, support and management personnel, and address the following regulatory issues:

  • Company organization
  • SOPS, policies and guidelines
  • Personnel qualifications and training
  • System design and specification
  • System development/implementation
  • Testing
  • Change control
  • Quality assurance
  • User documentation
  • Installation and maintenance

A written report summarizes the audit results and provides the client with specific recommendations to mitigate any technical or regulatory risks discovered.

Implementation Assistance

ILOGTEK provides professional consulting and expert implementation assistance to help clients remediate any 21 CFR Part 11 regulatory issues:

  • Validation plan development
  • Education and training
  • Documentation development
  • Security reviews
  • SOP development
  • Test plan development and execution
  • Quality assurance
  • Development methodology review/evaluation
  • Validation ‘gap’ analyses
  • Other ILOGTEK Services
  • Validation Consulting Services
  • Clinical Data Management Services
  • Monitoring Services
  • Quality Assurance Services
  • Information Technology Consulting Services
  • Contract Programming and Software Development Services
  • Patient Cost Analysis Services
  • Document Management Consulting Services
  • Needs Assessment Services
  • Metrics and Best Practices Services
  • Training and Documentation Services