OUR ACTIONS
evalu works in these areas
clinical studies
The data collected during research must remain intact and the systems hosting this data must be controlled to ensure the reliability of the study.
Learn more
regulatory affairs
The data submitted to the various authorities (FDA, EMA, national) must be reliable. Putting processes under control involves validating computerized systems.
Learn more
vigilance
In order to guarantee the safety of the patient and to reduce the risks on the health products, the integrity of the data must be put under control as well as the information systems.
Learn more
Drug analysis
The integrity of the data of an analysis makes it possible to make reliable the decisions made from them in the phases of development or production of health products.
Learn more
supply-chain production
The production equipment controlling the manufacture of health products and the associated management systems ensure good traceability of activities.
Learn more
quality assurance
To coordinate the implementation of quality policies, quality documents must be managed and the quality management system animated.
Learn more
infrastructure
The infrastructure must be brought under control as explained by the regulatory agencies (EMA, FDA, CFDA, etc.) because the integrity of the regulated data depends on it.
Learn moreCLINICAL STUDIES
To enable the marketing of new products or the extension of product prescriptions, preclinical and clinical studies are carried out in compliance with ethics and the regulations in force: good laboratory practices and good clinical practices.
Within preclinical and clinical studies, the quality of the data collected and compliance with regulations must be guaranteed: we assess the quality of service providers managing regulatory data electronically through audits and pilot projects to implement new systems or new system versions.
We bring the proof that the risks are controlled by the validation of the systems and that the integrity of the data is controlled .
Some INTERVENTIONS
Audit Clinical data management provider
We audited the service provider according to pharmaceutical standards
ECRF
We proceeded to the validation of the eCRF system
REGULATORY AFFAIRS
Regulatory affairs manage activities related to the registration and maintenance of marketing authorizations (AMM) for drugs.
Within regulatory affairs, we find document management systems (see Quality assurance expertise), publishing of regulatory files, monitoring of RIM regulatory activities, etc.
We intervene upstream of your projects to define the needs, to manage your projects, to validate the system before it goes into production or to manage the change.
We conduct audits of system providers or hosts.
Some INTERVENTIONs
INSIGHT PUBLISHER
By understanding the publishing process, we have defined the validation strategy for the system and its implementation.
ENNOV RIM
As part of the implementation of the regulatory information management software, we defined the regulatory risks, and drafted the checks to be carried out to put the system under control.
VIGILANCE
In order to reduce the risks on drugs, medical equipment, cosmetics, adverse effects are collected, the signal analyzed and transmitted to the authorities. This area is robotized with RPA and uses AI.
These automated, computerized processes must guarantee the integrity of the data , the safety of the patient through the control of the computerized systems.
We help choose the system, manage the deployment project . We manage the validation , the verification of the integrity of the data managed within its systems and the maintenance of the validated state of the system.
SOME INTERVENTIONs
ARISG VALIDATION
We validated the ARISg solution by capitalizing on the supplier’s file.
EVEDRUG QUALITY & VALIDATION
We provide support for the construction of the quality system, its animation and its review.
ARGUS AUDIT
We audited the validation file and maintained the system.
MAINTENANCE IN THE VALIDATED STATE OF SAFETY EASY AND PERIODIC REVIEW
We provided support so that the validated status of the system could be maintained by managing the change and capitalizing on the supplier’s documentation, performing the periodic validation review.
Analysis of drugs, medical devices, cosmetics
Analyzes are carried out on the products during their development, during studies, or during production in order to verify the quality of the products in compliance with the regulations.
The integrity of the data of an analysis makes it possible to make reliable the decisions made from them in the phases of development or production of drugs, medical materials, cosmetics. The equipment, LIMS must provide proof of this.
We intervene on the project management to set up, replace the existing systems, put under control the system by its validation and its maintenance in the validated state and thus to ensure the integrity of the data .
Some INTERVENTIONS
THERMO FISHER LIMS VALIDATION
Our added value was to consolidate the internal templates, to provide the method for structuring the test plan and the writing of the test sheets.
LIMS LABVANTAGE PROJECT MANAGEMENT
Our added value has been to be a catalyst in setting
in place of a governance, to present the expenses and to make it possible to free up resources. Conducting the project in agile mode made it possible to produce validated reports more quickly.
STARLILMS ADMINISTRATION
We intervened several times on the replacement of the administrator during the holidays for the management of the current activities by being force of proposal to smooth the operation with the editor, to manage the releases
DATA INTEGRITY TRAINING
We trained the team in charge of laboratory equipment to perform a data integrity risk analysis.
QUALITY ASSURANCE
Quality assurance defines and coordinates the implementation of the quality assurance policy (organizational methods / processes / audits) in order to comply with the applicable regulations.
In order to ensure quality , there is QMS, DMS , etc.
We help in the choice of systems, manage the deployment project , validation , verification of the integrity of the data managed within its systems, the maintenance of the validated state of the systems.
Some interventions
eDMS migration
We defined the migration qualification strategy with the members of the project team and conducted the qualification.
Trackwise audit management
We wrote the validation documents for the new Trackwise module and coordinated the execution of the tests and the management of anomalies.
Choice of DMS, QMS systems
On several occasions, we conducted the collection of needs, coordinated the call for tenders, enabled the choice of the system and managed the implementation project.
Administration Ennov
Assistance was provided to the administrator for change management, validation, project management to set up a new process, to respond to regulations in a pragmatic way.
PRODUCTION / SUPPLY CHAIN
Production equipment collects data and pilots manufacturing through management systems (MES, ERP) that allow decision-making on the manufactured product to release it on the market, and have sufficient traceability to allow product recalls.
We define a risk-based system validation strategy in order to comply with regulations and bring its systems under control. We lead your implementation or update projects to ensure good control of these systems and data integrity .
Some INTERVENTIONS
Validation of production equipment
We coordinated the retrospective validation activities and followed the progress by having a simple formalization adapting to the maturity of the client.
Quality assurance of production IS
We intervene in the review and approval of validation documents in accordance with internal procedures and we carry out the review of changes, management of deviations, investigations, CAPA and we participate in the improvement of the methodology.
ERP Validation
We have validated several ERPs with a pragmatic risk-based approach.
Management of the construction of SAP interfaces – LIMS
Together with the developer, we specified the interfaces, monitored their implementation and proceeded to check them.
infrastructure
The infrastructure makes it possible to store, transport and operate the applications and must be under control. In addition, infrastructure security is one of the points for ensuring data integrity. Applications are indeed dependent on infrastructure layers (network, servers, virtualization, middleware, etc.).
The infrastructure must be brought under control as explained by the regulatory agencies (EMA, FDA, CFDA, etc.) because the integrity of the regulated data depends on it.
We assist IT teams in the implementation of best practices, qualification of the infrastructure, audit of hosts.
Some INTERVENTIONS
Changing storage bay
We brought the method for the implementation of the new infrastructure component, defined the qualification strategy to comply with the regulations by having a pragmatic approach.
Change of infrastructure
We coordinated the project with the technical actors, organized the data migration, the qualification of the new infrastructure and the qualification of the migration.
Hosting audit according to the 27001 standard
We proceeded in delegation of internal audit to verify the application of ISO 27001.
