During our missions, we are often exchanging with our industrial clients on the appropriateness of using a BMS to set up a monitoring system meeting the GMP requirements 21 CFR Part 11.
It is not enough to measure !
Beyond measure, many questions must be asked. It is particularly necessary to guarantee:
- Secure storage of data (measurements, alarms) over several years, even decades, and easy recovery in case of an audit.
- Non-falsifying data afterwards.
- Track all the changes the system configuration with the date, author, and the reason for the change (audit trail of the configuration).
- The establishment of a rigorous users management system requiring often a direct link with the LDAP corporate directory.
Is it enough to put up a continuous measurement system to meet its obligations?
If necessary to comply with regulatory requirements in the pharmaceutical sector, the answer is clearly : no.
Validation : Significant cost
When choosing a system of monitoring, the costs of acquiring and commissioning must be taken into account, but they actually represent a small part of total costs.
The costs of initial validation of the system may be important but also the costs of additional qualification , for each change in the scope of surveillance. It is therefore essential to opt for a monitoring system that , by design , greatly reduces the cost of incremental validation.
For example , the system can, from a single point automatically update PLC programs and automatically change the structure of the database and update compliance reports by room.
VTracer : a solution which meets perfectly GMP requirements
IVTracer is a tool that brings to an industrial site a veritable ” monitoring infrastructure ” fully compliant with GMP requirements. Once installed, it is very simple and inexpensive to evolve thanks to a strong technology for automatic diffusion in the system in any case of change.
For optimal effectiveness, this infrastructure can be pooled across multiple production sites, on central servers.
Each site has just to connect its probes (wired or wireless) without the need for re-qualification of the central software. The savings costs can be significant.
Deployed on several thousand points of critical monitoring, constantly evolving to meet the demands of its customers, IVTracer is not linked to any manufacturer and therefore helps with the implement of a GMP monitoring solution strong, independent, sustainable and easy to maintain and evolve.
For more information please do not hesitate to contact us:
+33 (0)6 28 31 47 73
+33 (0)4 75 83 52 73