// standards
It is how we work from day one: documented procedures, traceable decisions and staff trained on the applicable standards. Here is what those standards are and what they mean in practice.
Data integrity principles
The nine attributes a record must have to be considered reliable across its whole life cycle. This is our primary reference criterion.
In practice: it is the grid we use to assess a system, a vendor or an architecture — before it is the grid we run gap assessments with.
European Commission
The Good Manufacturing Practice annex covering computerised systems. Binding for anyone manufacturing medicinal products in the European Union.
In practice: supplier management, validation, archiving, audit trail, business continuity. It is the text the documentation framework is built on.
FDA · United States
The US rule on electronic records and signatures. It applies to anyone exporting to or producing for the American market.
In practice: we verify that electronic signatures are uniquely attributable and non-repudiable, and that the audit trail is system-generated and cannot be altered.
Data management & integrity
The PIC/S guidance on good practices for data management and integrity in GMP and GDP environments. The most operational text on the subject.
In practice: it guides our approach to risk-based audit trail review and to handling data generated by laboratory instruments.
ISPE · 2nd edition
The reference guide for computerised system validation. It introduces classification by category and the risk-proportionate approach.
In practice: we classify each system and scale testing to its criticality, instead of applying the same documentation package to everything.
EU Reg. 2016/679
The European regulation on personal data protection. Relevant wherever systems process data relating to identifiable people.
In practice: technical and organisational measures are documented consistently with the record of processing activities, so that they can be demonstrated.
These are the standards we operate to and on which our staff is trained. For an up-to-date list of certifications held by Data Rei Srl as an organisation, please get in touch.
// operating commitments
These are commitments set out in our Code of Conduct, not marketing lines.
The Code of Conduct and the Sustainability Policy are approved by management, reviewed at least annually and available to clients and suppliers on request. Both documents are currently published in Italian only.
Anyone — employee, contractor, client or supplier — can report a breach of the Code of Conduct to management.
segnalazioni@datarei.it
