Bulk vaccine production building
Modification of the general layout of a bulk production building: removal of production equipment followed by total dismantling of the interior of the building (networks, partitions, AHU, etc.) before reconstruction and reintegration of the production tool
Validation of cleaning processes
Supporting our client in the implementation of the strategy and the validation process of the cleaning processes for a biotechnological bulk production unit.
Quality – QMS Medical Devices
Management of the quality manual and the Master File site, management of quality documents (drafting, review and archiving): policy, processes, procedures, templates and instructions based on the activity carried out
Computerised System Validation
Framework contract for the validation of computerised systems in health care institution
HSE Remediation Plan
As part of a project to remediate HSE actions on a pharmaceutical production site, implementation of actions and monitoring indicators for the various HSE processes.
Documentary actions to update procedures and field actions such as implementation of the LOTO methodology, deployment of URS HSE on the site.
Fabrication shop risk assessment
In the context of the implementation of new manufacturing processes linked to new production workshops, it is necessary to carry out a risk assessment of all production areas and associated technical areas, as well as maintenance operations linked to these new production workshops.
Quality management system for medical devices, the ISO 13 485 standard and the impact of the new RDM 2017/745 regulation
A quality management system applied to medical devices is governed according to ISO 13485. This non-mandatory standard applies to organizations involved in one or more stages of the life cycle of a medical device ranging from design to development and also including production, storage, distribution and post-market surveillance. Companies working on the recycling of these products are also concerned.
