ICH E6 (R2) Compliance Gap Analysis

ICH E6 (R2) Compliance Gap Analysis

In order to ensure compliance with ICH E6 (R2) the first step is to understand the gaps between the standards and approach defined by your current QMS and those which will be required when following the new guidance. This second step on our five step process will identify those gaps and define the most efficient approach to making any required updates.

Current State QMS Review

We begin step two with a thorough review of your current QMS. This typically covers:

  • Processes
  • SOPs
  • Job descriptions
  • Working practice documents

Depending on the scope of the analysis we are also sometimes asked to assess training materials.

Our aim is to have as little impact on existing QMS documents as possible whilst ensuring compliance, and so take a pragmatic approach to what is required in order to become compliant, and also what is not.


The results of this review are compiled into a report which will be delivered and walked through in order to ensure complete comprehension of all comments and recommendations.

How Long Does It Take?

Depending on the size and complexity of the QMS the process of review and development of the recommendations report will take between 6 and 12 days.


The Output

The output from the gap analysis is designed to be clear, concise and of high value to the customer. It is also the main input to the next step in the five step process, and so we need to ensure that fir for purpose as the customer moves to the QMS update and implementation phase of their compliance project.

For each document we assess, we answer the following questions:

  • Is the document impacted by ICH E6 (R2)?
  • If so, what level of revision is required to bring the document in line with the needs of ICH E6 (R2)?
  • What do we recommend in terms of the type and level of changes?
  • What specific section of ICH E6 (R2) are we referencing when we recommend a change?

There may also be documentation required to be added to the QMS, for example job descriptions for new roles, such as central monitor (see our recent blog item Central Monitor Job Description )


Why Use TRI?

TRI have performed many ICH E6 (R2) gap analysis for CRO and Pharma companies and continue to do so. This experience has allowed us to develop both experience and assets which can be used to accelerate, simplify and reduce the cost of going through this process. The impact of non-compliance and failure to achieve full compliance through poor analysis at this stage is high for both companies and patients, so why take the risk?

What Should I Do Next?

To contact us and find out how we are helping companies to prepare for ICH E6 (R2) and how we could help accelerate your route to compliance, simply click on the link below:

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