Gap Analysis.
Identifying and supporting compliance risk and beyond.

What is compliance Gap Analysis?

Gap Analysis serves as a vital methodology for organisations to assess and enhance their current conditions and practices, particularly in the context of compliance and relevant standards.

This strategic process involves a comprehensive examination of existing practices to pinpoint gaps and areas requiring improvement. It essentially measures the difference between the current state and the desired state, evaluating actual performance against expected or desired results.

For compliance, product quality, and patient safety, conducting a Gap Analysis is a proactive measure that aids organisations to identify non-compliance and vulnerabilities.

By adhering to best practices and adopting a risk-based approach, organisations can systematically identify these gaps, prioritize necessary actions, and enhance their processes and systems to meet or exceed regulatory expectations.

The iterative nature of regular Gap Analysis, coupled with robust corrective and preventive actions, cultivates a culture of continuous improvement within an organization.

This ongoing commitment to assessment and refinement allows an organisation to adapt swiftly to changes in regulations, industry standards, and emerging risks.

The cumulative effect of this approach contributes significantly to regulatory compliance, product quality, and patient safety. It helps an organisation meet minimum requirements and positions them to excel operationally.

Integrating regular Gap Analysis into operations demonstrates a commitment to excellence, continual advancement, and the highest standards of quality, safety, and compliance.

Why choose Aegisana’s Gap Analysis services?

Our extensive process.

Aegisana’s compliance team has extensive expertise in conducting Gap Analyses tailored to the needs of small, medium, and large companies across GCP, GVP/VGVP, GMP and GDP.

Our comprehensive process typically covers the following key elements:

  • Scope and Objectives Definition: Clearly defining the areas to be assessed, ensuring a targeted and focused approach to the Gap Analysis.
  • Cross-Functional Team Engagement: Involving representatives from all relevant stakeholders to ensure a holistic understanding of the operational landscape.
  • Applicable Regulatory Landscape Review: Assessing the current regulatory environment to identify any new requirements or guidelines that may impact compliance.
  • Risk-Based Assessment: Evaluating levels of risk in terms of criticality, patient safety, non-compliance, and business impact to prioritize areas needing attention.
  • Documentation and Procure Review: Scrutinizing essential documents such as SOPs, quality manuals, and protocols to ensure adherence to compliance standards.
  • On-Site Audits and Inspections: Conducting on-site assessments, especially for GMP and GDP analyses, to ensure a firsthand understanding of operational practices.
  • Data Integrity: Examining controls and practices within electronic systems to ensure the integrity and reliability of data.
  • Corrective and Preventive Actions (CAPAs): Developing comprehensive remedial action plans to address identified gaps and mitigate potential risks.
  • Periodic Review: Monitoring and reviewing the effectiveness of implemented CAPAs, Key Performance Indicators (KPIs), and staying abreast of any changes in regulations.

Strategic risk reduction.

By adhering to a systematic and thorough process, Aegisana’s compliance team aims to provide you with a tailored and effective Gap Analysis that not only identifies areas of improvement but also facilitates your strategic decision-making and long-term compliance sustainability.

We believe conducting regular risk-based gap analyses is a cornerstone of a proactive and comprehensive approach to ensuring company-wide compliance and serves as a strategic tool to identify, assess, and mitigate these risks, ultimately enhancing your organisation’s overall compliance framework.

By allowing us to identify where you may be at risk, you can allocate resources strategically, invest in targeted training programs, and implement tailored corrective and risk mitigation strategies. We believe this iterative process of evaluation and adjustment not only strengthens compliance but also enhances overall organizational efficiency and effectiveness.

Our aim is to build confidence in your outsourcing partnership with us, providing you with peace of mind, knowing that your operations have been thoroughly scrutinized by a dedicated team of experts who prioritize professionalism, transparency, and a commitment to your success.

Through this comprehensive and collaborative approach, we aim to build a lasting partnership with Aegisana founded on trust, reliability, and the shared goal of achieving operational excellence.

All of our compliance services adhere to the regulations and principles of the EMA’s guidelines on compliance.