Data and data integrity are of the utmost importance to guarantee the patient’s safety, as well as the quality of pharmaceutical products within the life science sector.
Are you interested to examine and optimise data integrity within your organisation? The Pauwels Consulting data integrity experts have extensive experience in the field of audits, implementation and compliance of data integrity.
We would be pleased to assist you with data integrity assessments and training, the preparation of data integrity audits and the implementation, optimisation and guarantee of your data integrity.
Data integrity in practice
Data integrity refers to a variety of important processes to guarantee the completeness, accuracy and consistency of data during the total life cycle of the pertaining data. Naturally, this must all be in compliance with the applicable legal requirements. It is of the utmost importance for each system saving, processing or recovering data.
Within the GxP environment, the submission of evidence in accordance with the laws and regulations is extremely important in order to prove the safety and efficacy of a product. For instance, in the event of legal disputes.
After all, in the medical world, regulatory authorities, such as the FDA and EMA, often assume a medicine is unsafe, a medical appliance does not function or that data is corrupt subject to proof of the contrary, not the other way around. The burden of proof is on the manufacturer.
However, this ‘evidence’ must meet a number of requirements. The FDA uses ‘ALCOA’ as a guideline for complete, accurate and consistent data:
- A – attributable;
- L – legible;
- C – contemporaneously recorded;
- O – original or a true copy;
- A – accurate.
Challenges within data integrity
Continue to invest in the patient’s safety and the quality of the product is the main priority for pharmaceutical companies. Data integrity is a very special aspect thereof.
Companies wishing to guarantee the integrity of their data are confronted with a vast array of challenges, including:
- large data sets (big data) require advanced statistical or mathematical analyses;
- quickly evolving and increasingly more strict regulation requirements (for example GDPR);
- lack of integration in large organisations with many silo’s and disparate data sets;
- data streams are often extremely complex and interconnected;
- many electronic systems and computer systems play a role when collecting, processing and saving data;
- employees involved must continuously be informed on the results of their actions within the framework of data integrity.
Apart from the remediation of existing systems/processes in the field of data integrity and the implementation of new systems in accordance with the most recent regulations, investing in the proper training and awareness of data integrity in all its aspects will be a continuous must for the future.
Data integrity at Pauwels Consulting
Are you interested in advice or support related to the guarantee of your data integrity? Our data integrity consultants have extensive experience in the field of data integrity. They would be pleased to assist you with:
- data integrity assessments and audits of your computer-operated systems and laboratory equipment, as well as all your GMP processes;
- the identification of critical or non-critical data integrity gaps, based on a risk assessment;
- the set-up of constructive processes to manage breaches of data integrity;
- the introduction or observance of strict processes involved in each aspect of the data life cycle: collecting, processing, reporting and evaluating;
- project-based remediation of existing processes and systems;
- support to handle new processes and systems in accordance with the latest data integrity requirements: procurement advice and incorporation of the required data integrity requirements in the qualification and validation documentation;
- your data governance plan (in accordance with the GAMP guidance);
- data integrity training and sessions;
- audit preparations;
- remediations in accordance with the latest developments in terms of regulations and guidelines;
- validation of backup procedures.
Would you like to have more information?
Are you interested in more information regarding data integrity possibilities for your organisation? Do not hesitate and contact us, without any obligations.
Our data integrity consultants would be pleased to assist you with data integrity assessments, training, the preparation of audits and the implementation, optimisation and guarantee of your data integrity.