Data integrity is one of the fundamental pillars of any quality system in regulated environments. It consists of ensuring that the data generated during the manufacture, control and distribution of pharmaceutical products is complete, consistent, accurate and protected against undue alteration, both in electronic and paper format.
This aspect has become especially relevant after multiple "warning letters" issued by the FDA in recent years, especially in facilities inspected in countries such as India and China.
Since then, regulatory agencies such as the FDA, EMA and MHRA have intensified their vigilance on this issue, considering any failure in data integrity as a critical non-conformity.
How can we help you?
Our specialized data integrity service is designed to assess, strengthen, and consolidate critical data records and document management systems in your organization.
We offer:
- Specific data integrity audits
We evaluate processes, records, equipment and computerized systems to detect risks, vulnerabilities or non-compliances in terms of data integrity. We issue a technical report with classified observations and a prioritized action plan.
- ALCOA+ Compliance Diagnosis
We verify that your records comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Durable, and Available).
- Staff training
We offer practical training for operators, technicians, quality managers and managers, focused on raising awareness of the importance of recording data correctly and in real time, as well as preventing involuntary errors or intentional manipulations.
- Review of computerized systems and SOP documentation
We review the configuration, validation and access control in electronic systems (LIMS, SCADA, HPLC, ERP, etc.), and we help to draft or adapt standard operating procedures that regulate the correct and safe use of these systems.
Why is it crucial to ensure data integrity?
A failure in data integrity not only compromises the quality of the product, but can put the patient's health at risk, lead to batch blocks, generate serious regulatory consequences (observations, restrictions or prohibitions) and damage your company's reputation.
Our approach is not just paper-compliant: we want your system to ensure that every piece of data recorded is reliable, traceable and verifiable, as required by international health authorities.
Why trust us?
- Practical approach adapted to operational reality
- Experience in audits and trainings in data integrity
- Up-to-date knowledge of the requirements of FDA, EMA, MHRA
- Improvement plans with realistic and applicable corrective actions
- Support in the documentation, validation and safe use of computerized systems
Do you want to ensure the reliability of your data before an audit?
We help you detect risks, train your team, and harden your systems so that data integrity is not a weak point.