Compliance Overview

Our personnel have experience of qualifying / validating a range of process equipment, control systems and information system applications in accordance with phased development and operational lifecycles

Strategy DevelopmentValidation InfrastructureValidation PlanningDelivery

Development & TrainingManagement SeminarsTechnical AwarenessTechnical Skills

Electronic Records / SignaturesGap Analysis / CAPA

Strategy Development

Our consultants work with senior management teams in order to highlight the business benefits derived from regulatory compliance and the risk of non-compliance. Corporate and Site validation strategies are developed in order to provide a risk-based solution to compliance issues.

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Validation Infrastructure

We can develop validation processes, procedures and systems based of industry standard development and operational lifecycles. Customer personnel are actively engaged in the development of such processes, procedures and systems in order to ensure appropriate buy-in.

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Validation Planning

Site Validation Plans are developed to provide a prioritised approach to facility, equipment and computer systems validation. Maintainable inventories are established in order to identify critical systems requiring validation and their current validated status.

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Delivery

We offer managed project teams or key individuals to supplement a customer’s internal team in order to meet prospective or retrospective validation needs. Our consultants and practitioners are competent in all aspects of validation associated with system development and operation. Typical services provided include but are not limited to:

  • Validation Planning (VP)
  • Validation Master Plan (VMP)
  • Supplier Auditing
  • User Requirements Definition and Review (URS)
  • Risk Assessment
  • Design Specification (FDS/DDS)
  • Design Qualification (DQ)
  • Software Code Review
  • Software Configuration Management
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Pre-Delivery Testing (FAT)
  • Post Delivery Testing (SAT)
  • Data Migration
  • System Cut-over
  • Performance Qualification (PQ)
  • Traceability Matrix
  • Validation Reporting (VR/VSR)
  • Post-Implementation Monitoring
  • Operational Compliance

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Development and Training

We offer off-the shelf and custom training programmes to meet the specific objectives of your organisation. With our hands-on experience of international regulations (EU, US, Japan, Canada, Australia, etc.), coupled with our in-depth knowledge of industry best practice gained through participation in industry forums, we are able to provide the appropriate business and technical focus to suit the varying needs of the delegates.

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Management Seminars

Management seminars focus on the business need for pharmaceutical validation, this outlines the regulatory requirements of key markets and the business benefits that can be gleaned from effective, scaleable validation practices. Case studies are used in order to heighten awareness of the potential cost of non-conformance. Open dialogue provides managers with the opportunity to share issues and obtain insight into proven strategies for addressing such issues.

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Technical Awareness

Technical awareness training provides insight into the principles of pharmaceutical validation. These training courses can be offered for control and information systems, process equipment, utilities and facilities. From this training, delegates will gain insight into European and US regulatory requirements, validation lifecycles, documentation requirements, roles and responsibilities, user and supplier relationships and ongoing management of validation during the operational phase.

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Technical Skills

With this type of training, delegates will learn how to:

  • Interpret current regulations
  • Develop robust user requirements
  • Conduct supplier audits and manage shortfalls in supplier capability
  • Manage multiple suppliers
  • Conduct technical and project risk assessments
  • Planning risk management strategies
  • Manage design, installation, operational and performance qualification
  • Report validation activities
  • Establish and maintain operational compliance
    • Training
    • Change control and configuration management
    • Disaster recovery and business continuity
    • System archive and restoration
    • Maintenance planning
    • Security
    • Periodic review and revalidation

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Electronic Records and Electronic Signature Compliance Management

Electronic Records and Electronic Signature (ERES) regulation continues to be a prominent issue for pharmaceutical organisations throughout the world. Although 21 CFR Part 11 is currently the most prominent regulation, European directives relating to use of electronic signatures and ISO Information Security Management standards mean that this issue has a global perspective. IDEC offer a range of services that enable our customers to understand the regulation within the context of their business operation and to apply a practical interpretation enabling prioritisation of remedial action.

Senior Management seminars/ workshops enable senior business and quality managers to understand the requirements of current regulation and guidance within the context of their business operation. These seminars/ workshops define the requirements of ERES regulation in business terms:

  • Scope and requirements of the regulation
  • Benefits of compliance
  • Risks of non-compliance
  • Current regulatory expectations

Detailed 1 and 2 day workshops provide in depth knowledge of the regulation, processes and tools for assessing compliance and planning tools for prioritising interim and longer-term corrective actions. Delegates are given opportunities to discuss specific issues within their organisation and develop strategies for achieving pragmatic compliance.

We are able to advise on the best approach to achieving compliance. Be it on a global or local scale, we can advise on Project Organisation, Project Process, Assessment Tools and Methods, Reporting Tools and Methods and Training to enable organisations to achieve appropriate and consistent compliance within a reasonable time frame.

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Gap Analysis and Corrective Action / Preventative Action (CAPA) Planning

The process of Corrective And/or Preventative Actions (CAPA) and gap analysis is the basis for continual improvement within a business's quality system. We are able to provide project teams to carryout gap analysis and action planning activities either in full or to supplement existing customer resource. Our consultants and practitioners have worked with many organisations and therefore bring a harmonised perspective of the issues faced and pragmatic proposals for resolution.

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“Customer Focused Organisation”