Deviation expertise · ELEMENTAIRE method
A swelling backlog, lengthening processing times, criticality that depends on who assesses it, investigations wrapped up the day before the deadline: we help pharmaceutical sites regain control of their deviation process. Since 2019, the ELEMENTAIRE method has been deployed at 11 manufacturers, from SMEs to multi-site groups.
−79 %backlog in 7 months, after a major inspection finding
−64 %minor deviations across a group of 4 sites, in 22 weeks
−45 %major deviations over the same period, ANSM CAPA closed
−41 %average processing time, from 36.7 to 21.5 daysEvery site is different: for some, the problem is lead time; for others, it’s the value of the investigation. We activate the levers you need.
A risk assessment based on ICH Q9, adapted to your site, which sets in one go the criticality, the depth of investigation, the search for wider impacts and the need for CAPA. New events are assessed by a collegial committee within 48 hours.
ICH Q9decision committeedeviation / event filter
The ELEMENTAIRE method links the tools your teams already know into a step-by-step approach, with a single starting point to avoid the blank page, a structured analysis of hazards, risks and impacts, and a report written during the investigation.
ELEMENTAIREroot causeself-supporting report
Visual management everyone can read and a 15-minute daily ritual between quality and production to unblock files before they become urgent. Indicators are updated automatically from your QMS.
BOOSTERbacklogprocessing time
Dedicated investigators from around ten deviations opened per week: files are picked up without delay, workload can be managed, and practices stay consistent from one investigator to the next.
dedicated investigatorsroles & responsibilities
Consultants trained in ELEMENTAIRE and equipped with our tools reinforce your teams: investigating on your behalf, clearing a backlog as a task force or filling a vacant position, on site or remotely.
reinforcementbacklog task forceEffective Quality Brigade
Polton, our investigation AI developed with Gordios, augments investigators’ work: it decides nothing, but it doubles their productivity. Your data stays in Europe, on mostly local models.
Poltonsovereign AI×2 productivity
Recognised in inspection. On one of the sites where it is deployed, the ELEMENTAIRE method and its self-supporting reports were noted as good practice by FDA inspectors.
412 deviations in backlog, including 161 blocked batches. A collegial decision committee, coaching of 6 investigators, daily management across 3 areas and a 2-day task force.
Criticality not aligned with risk, investigations started too late. Group procedure, new “event” category, 132 coaching sessions across 4 sites.
Inconsistent decisions and an ANSM CAPA to close. Definitions and criticality reviewed, procedures rewritten, 64 committees supported until autonomy.
First effects within a month with the management system, consolidated results in 4 to 7 months on one site.
A deviation is a departure from an approved procedure, specification or instruction (GMP), occurring during the manufacture, testing or storage of a medicinal product. It must be recorded, assessed according to its risk, investigated to find its root cause and, if necessary, lead to a CAPA.
By combining three levers: daily management of the portfolio (visual management and a 15-minute ritual), a rapid committee assessment of each new event, and an investigation depth proportionate to risk so that a minor deviation is no longer handled like a major one. On our assignments, for example, the backlog was divided by 5 in 7 months.
The ICH Q9 guideline on quality risk management requires effort to be proportionate to risk. We translate it into concrete severity, probability and detectability criteria, adapted to your site, which allow 4 decisions to be made at once: criticality, depth of investigation, the search for wider impacts and the need for CAPA.
The first effects of the management system are visible within a month. A revised process, trained investigators and autonomous committees generally take 4 to 7 months on one site, longer for a multi-site roll-out.
Yes. We have adapted the approach to TrackWise, ENNOV, SAP or simple Excel files. The tool’s workflow is adjusted to the method, not the other way round.
Yes, it’s a common case. We build the response and the remediation plan with you, then put in place the process that will demonstrate its effectiveness at the next inspection.
Tell us about your situation in thirty minutes. We’ll tell you what we would do, and where to start.