- Ghislenghien BE & Tournus FR
Our services
Ensure traceability of the treatment, its execution, and the controls performed.
In GMP environments and sectors with high quality requirements, an intervention must be traceable: scope, operations, monitored parameters, and controls performed.
The stakes
01
Define and record the elements necessary for traceability of the operations performed.
02
Ensure continuity between what was defined, what was performed, and the results obtained.
03
Structure the information necessary for technical and quality teams, for requalification, or for audit.
Your need
Our approach
Documentation is defined before the intervention, populated during its execution, and completed with the planned results and controls.
01
Define the requirements
Identify the documents, data, controls, and review workflows required.
02
Prepare the materials
Define the protocols, checklists, and materials necessary for recording operations.
03
Ensure traceability
Record the planned elements during the intervention and collect the associated results.
04
Gather the agreed documents and results, specify the points remaining to be examined, and deliver the file according to the workflow defined with your teams.
Understand traceability
Technochim has its own traceability system enabling it to document its interventions through the protocols, checklists, intervention records, control data, and reports defined for the project.
The file content is defined with your teams before the intervention. Depending on the agreed scope, it may include:
The expected documents, delivery methods, and review workflow are specified for the project.
When the client’s quality system requires it, our teams can also work with your own protocols, forms, and applicable documents, in order to integrate the intervention into your documentation organization.
In both cases, the documentation scope and deliverables are defined before the intervention begins.
Traceability is part of Technochim’s quality DNA. It accompanies our interventions in sectors where control of execution and the ability to provide evidence are essential.
Pharma & Biotech • GMP Environments • Nuclear • Aerospace & Aeronautics
In the pharmaceutical industry, this documentation contributes particularly to quality review, maintenance files, requalification activities, and preparation of elements required for audit.
Treatment documentation contributes to the client’s quality system. Acceptance, qualification, or return to service of the installation remain governed by the site’s procedures and responsibilities.
Pharma installations
Clean utilities
Documented maintenance
Requalification
Interventions in high quality requirement environments
Technochim expertise
At Technochim, treatment, verification, and documentation are inseparable when they are part of the scope defined with the client.
Our quality system ensures documentation continuity from intervention preparation to delivery of the corresponding file.
