Compliance Analysis & Gap Assessment

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Compliance Analysis & Gap Assessment

The international legislation in GxP constantly changes. Thanks to advanced training programs our validation and compliance engineers have become experts in current FDA and EU regulations and directives. Our validation and compliance engineers They support companies in the full preparation for audits and inspections by customers or by the government.

Compliance analysis

Business processes and procedures are scrutinized for compliance with guidelines such as data integrity, good manufacturing practices, good laboratory practices, good documentation practices, and good distribution practices. Preparation for specific audits (FDA, MHRA, WHO GMP etc.) can also be carried out.

Overview of processes

The strategy is planned in detail in consultation with the client. A standard project consists of five different phases.

Determining the scope

The scope (i.e. the relevant processes or procedures) is mapped out for each department.

Checklist

A checklist is formulated in consultation with the client’s project stakeholders.

Gap Analysis

Going through the checklist will produce an overview of what the guidelines expect and what is effectively in place. A distinction is made between each non-conformity according to severity/impact (criticality).

Action list

Each non-conformity is linked to an action, responsible party, and timeline.

Review/Implementation

After completion of all the action points, we go through the checklist again for verification.

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