SGS recognizes and understands the challenges FDA regulated organizations face in keeping current with the constant changes in industry standards, implementing innovative technologies, and adhering to regulatory compliance. SGS' healthcare's regulatory compliance practice has extensive knowledge and expertise in the industry and understands the need to establish documented evidence which provides positive assurance that IT systems are performing in accordance to predetermined specifications and quality standards.

Business challenges
Many organizations may manage to meet regulatory expectations, but forgo efficiency due to poorly conceived and executed validation and compliance activities. Validation and compliance services can become inefficient and costly when it is not managed appropriately. Some of the challenges presented to companies are as follows:

• Ineffective and inefficient Computer System Validation (CSV) methodologies and polices
  • Inadequately formulated strategy and improper utilization of validation resources during the validation
  • lifecycle of the project.
• Under/Over-testing and re-testing of systems due to insufficient planning and execution
  • Lack of compliance effectiveness by project management and team members
  • Strategy and governance are not communicated effectively to team members by project management
  • Inconsistencies in the interpretation of compliance standards by management and team members
  • Improper alignment of resources to compliance tasks.

SGS' Value-Add for Strategic IT Compliance SGS has built a life science consulting practice that will enable organizations to become compliant with IT-related regulations and guidelines. We assist our clients to improve the level of compliance while reducing their compliance costs. SGS' approach leads to reduced cost related to compliance procedures. As regulatory agencies increase the standards on industry in order to reduce risk and increase quality in both research and manufacturing, compliance is critical for the survival and growth of companies in the healthcare arena.

SGS' extensive experience in the IT compliance space encompasses areas governed by the FDA, and other regulatory agencies. Our IT compliance services address GxP (GMP, GLP, GCP) QSR, IQ/OQ Requirements, PDMA, HIPAA, SOX, HR privacy, and other applicable regulations. We have expertise in validating single site, multi-site and enterprise wide systems used in:

• Clinical operations
• Clinical operations
• Manufacturing/distribution operations
• Regulatory compliance
• Sales and marketing

Strategic Compliance Services

We can ensure the implementation of a quality system for our client's IT operations that is efficient, effective, and compliant. Our tested methodology and approach will improve IT compliance business processes while concurrently avoiding unnecessary tasks. Our experienced staff has the requisite knowledge that enables them to capitalize on client's existing practices/procedures where required which leads to efficiencies in cost and manpower.

Validation & Compliance Methodologies

The use of a consultative and corroboration strategy enables us to provide a mix of hands-on System Development Life Cycle (SDLC) management and Computer Systems Validation (CSV). Our Validation team works closely with the client team to determine and process all validation needs. We aim to thoroughly understand our client's strategic business requirements and align our validation services accordingly. SGS' process involves:

• Implementation of validation processes to industry standards and best practices
• Evaluation of existing compliance/validation processes to identify gaps in standards and industry best practices
• Concept through implementation of a validation process adhering to a risk-based approach
• Incorporating a risk-based approach into strategic compliance and validation methodologies for computerized systems to address official FDA guidelines. "Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application, August 2003."
• Streamline validation processes and deliverables
• Risk & gap analysis
• Develop a centralized database to track and analyze a portfolio of systems in order to determine:
  • Critical functionalities unused or under-utilized
  • Redundancies of functionalities inherent in the process
  • Functionalities in process that can be reduced or eliminated

Quality System

• Business process advancements and enhancements in systems operations and management
• Quality System implementation (SOPs, policies, documentation, guidelines, etc.)
• Analyze and align current procedural elements with industry best practice
• Evaluation and recommendation with regards to regulatory and system training for team members and management
• Assessment and remediation of regulated operations for regulatory compliance from concept through execution

Corrective and Preventive Action (CAPA) Services

Our CAPA capabilities cover a wide range of consultative services which includes:

• Process assessment and improvement
• System implementation
• Validation

SGS has demonstrated experience in:

• Providing validation and testing support to CAPA system implementation projects for our pharmaceutical clients
• Performing audit readiness analysis of CAPA processes
• Evaluating the effectiveness of an automated CAPA system to identify unused or under-utilized functionality that improve the CAPA process
• Reviewing process flows and identifying areas for improvement in the overall CAPA process via benchmarking against industry best practices.