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Quality Management

Data Integrity in Life Sciences

Data Integrity within the GxP Environment

Data integrity must be firmly anchored in the culture of a company. It should be communicated and experienced across departments and hierarchies. The demand for data integrity in itself has been long-standing: the paper-based manufacturing documentation has already been subject to review, and that surely has not changed since electronic data acquisition came about.

What is really new about the topic

New, in particular, is the increasing complexity of state-of-the-art IT solutions and automation infrastructure! How can one be sure with the enormous amount of data from a wide range of organisations, technologies and processes that all is “ALCOA+”? During an audit, it is irrelevant whether data integrity violations are due to deliberate falsification, a mistake, or system failure. The application of the right tools and measures ensures the accuracy between the data and its references – from acquisition, over storage, all the way to destruction of the data.

Key to data integrity is the introduction and implementation of a holistic information management strategy. Starting point is the identification of data and data flow. On that basis, sustainable processes for the secure handling of data in all divisions of the company are implemented.

We are specialised in the life sciences industry, and are familiar with the regulatory requirements regarding data integrity (FDA, EMA, MHRA).

Data Integrity Awareness Training

The team is a crucial element. Deliberate falsification is not the factor behind most data integrity violations. Most of the time, these are just a result of simple lack of knowledge, negligence, or even a wrong management strategy. Are your employees aware of what is most important? Our awareness training is there to throw light on and create awareness of the hurdles, and demonstrates how to avoid them.

Data Integrity Maturity Assessment

Our experts will carry out an objective and thorough data integrity maturity assessment pursuant to the regulatory requirements. We will analyse the status quo with professional and technical know-how, thoroughly review your existing data flow, and reveal all potential deficiencies. The goal is to prepare a clearly structured action plan to eliminate relevant risks.

Data Integrity Readiness

Sustainability is the keyword when it comes to data integrity. How could a company facing an audit or inspection benefit from having their current status regarding data integrity reviewed, and “repair measures” implemented at short notice?

The most striking symptoms might be fixed this way, at best – but no sustainable data integrity is gained. The current status of data integrity within the process and systems must be known, there is no doubt about it. But if the constant need to start over again from scratch, and be driven by external events such as audits and inspections is not an option for you, the results from the Data Integrity Maturity Assessment should be implemented as a more sustainable measure. To ensure sustainable data integrity within a company (Data Integrity Readiness), we recommend the implementation of a Data Integrity Program with the following elements:

  • Creating awareness about data integrity within the organisation
  • Training for all (relevant) personnel
  • Definition of the relevant checks and regular execution of Data Integrity Maturity Assessments
  • Analysis of the data flow within the organisation as well as electronic and non-electronic data flow
  • Implementation of Good Records Management Practice in all divisions of the company
  • Definition of data integrity requirements at the introduction of new systems taking into account information architecture and processes