|
The Industrial systems Centre of Excellence is a technical and regulatory resource for ADN clients and consultants
Industrial systems are the focus of many regulatory inspections
Over the last few years we have observed an evolution towards relational data architectures which open the doors to compliance with the 21 CFR Part 11 and with electronic batch files.
This logical evolution will need to consider the compliance requirements for real-time data analysis, data storage export and re-processing.
|
This logical evolution satisfies a number of essential points such as the filing of the data, real time history or the investigation an incident, export for complementary reprocessing or the guarantee of the maintenance of the integrity of the data.
All of these systems are directly used :
- In the Manufacture of active product (production automation, fermentation, chromotography, etc.) ...
- .. or in formulation (chaînes de répartition, équipement de galénique, lyophilisateur),
- In controls of sterility and environmental conditions associated with pharmaceutical production (autoclave, environmental control system...),
- Critical utilities(Water, air…)
- Equipment maintenance management, Electronic batch records (EBR),
This is why the Industrial data Centre of Excellence proposes to accompany you in:
- all steps of system acquisition of new systems and updates to existing systems
- The choice of the software solution most suited to your needs
- A phase of follow-up and setting in use to review management of the systems and IT Infrastructure to ensure extended compliance.
Thanks to our experience and partnership with the leading systems providers and our regulatory knowledge, we can help you :
- to evaluate the impact of this equipment in your companies process flow,
- à identifier et planifier les actions à mettre œuvre pour prouver la maîtrise des flux de données èmes
- à planifier les actions correctives ( ex. 21 CFR PART 11 dans le cadre d’un projet PAI )
- à qualifier et valider les solutions choisies en fonction de vos exigences et des textes réglementaires en vigueur et des « guidelines" reconnus (predicate rules, 21 CFR PART11, ICH, GAMP 4 et GAMP 5),
- à suivre et maintenir la validation de ces systèmes en fonction de leur contexte d'utilisation pharmaceutique,
- à mieux appréhender les éléments clés de la validation des systèmes informatisés industriels (supports de formation, conduite du changement).
