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Pharmaceutical manufacturing line

A 360 analysis of your QMS completed with the design of the most adapted Improvement Plan

Ideal if your activity is in relation with the pharmaceutical, cosmetic or medical device industry.


A unique computerized expert system, providing a quantitative, holistic and non-subjective model of the adherence to applicable referentials.

Choose Iniscient

BUSINESS
GROWTH

Get comprehensive and accurate mapping of systemic risk exposure.

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Develop a customized action plan aligned with your strategy and resources.

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Simplify and improve your QMS to address requirements while enhancing its agility and reducing costs

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Manage your suppliers with increased efficiency and reduced effort

Product
About
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Time, resources, and operations

Iniscient is foremost a knowledge management tool. It highlights, in a non biased approach, all significant characteristics of the organizational system, all potential vulnerabilities, all opportunities of reinforcement.

Figures & facts

According to the European Federation of Pharmaceutical Industries and Associations (efpia-2017-reg-inspec5on-survey_public-summary), the average cost of an inspection for a manufacturer medium sized site is 350k€, for 160 days of work.

Auditors can perform a maximum of 20 inspections per year.

A full and unbiased view

Traditionally, preparation and conduct of audits or inspections often rely on a limited and partial review of the existing documents and data and may be subject to biased approaches or interpretations.

Figures & facts

Only a few percent (<5%) of QMS documents are generally reviewed during an inspection.

Improvement plans

Improvements plans, corrective and proactives actions (CAPA) need to be defined and rolled out in alignment with the company strategy, commensurate to available resources, and continuously updated and adapted.

Figures & facts

A manufacturing site is exposed to 50’000 to 250’000 vulnerabilities or potential gaps against referentials.

Iniscient addresses your challenges

Iniscient assesses automatically and comprehensively your Quality Management System against all existing guidelines, policies and procedures, whether external or internal and by proposing an improvement plan tailored to your needs, strategy and available resources.

Your benefit

Permanent Inspection Readiness

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Preparation, audit & inspection

Iniscient places the Client Organization in a situation of Permanent Inspection Readiness. In addition to GxP, it can also embrace topics such as EHS, CSR, …

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Monitoring the audit plan

Managers can easily monitor the plan execution and regularly reprioritize when and where deemed necessary.

Knowledge management & decision making

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Unbiased approach

Iniscient is foremost a knowledge management tool. It highlights, in a non biased approach, all significant characteristics of the organizational system, all potential vulnerabilities, all opportunities of reinforcement. 

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Comprehensive risk reports and simulations

Managers can address priorities based on full reports and proactively assess the systemic response by simulating future evolutions.

Efficacy and Performance

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Minutes of analysis vs days

Iniscient analyzes a package of 5’000 documents in less than 15 minutes. Hence, Iniscient is totally compatible with a routine implementation in daily operation as well as in the context of action under stress like in crisis management, due diligence, inspection and certification audit….

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Resources are refocused on field activities

It can be estimated that up to 30% of the required man hours needed to meet GMP requirements may be relocated on productive operations, thanks to Iniscient.
Moreover, several studies conclude that the cost of non-compliance is between 2.5x and 3.0x the effort required to be compliant.

Your benefits
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Our uniqueness

1.

Complexity made simple

Regulatory requirements, referentials and standards are densely interconnected - thus, forming a Complex System - while not being harmonized, i.e.: all provisions are not fully aligned and therefore cannot be simultaneously addressed.
With Iniscient, each single requirement is analyzed in its global context. Hence, Iniscient makes clear how to adhere to the requirements and satisfy the expected level of compliance.

2.

Proactivity in a Dynamic Context

The control of the QMS must take place in continuously evolving regulatory and technological frameworks. Kernelis Innovation maintains a longitudinal surveillance of the applicable context and the resulting database of compiled referentials is permanently updated and made ready to be integrated in Iniscient. With Iniscient, the manager has the needed tool to efficiently shape its documentation system to support his risk and compliance policy.

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Iniscient
Key advantages

360 view on your compliance

Get a 360 view on your compliance and your risk exposure. Iniscient provides objective, comprehensive, and accurate compliance analysis of relevant regulations and standards as well as risk exposure. It achieves this by analyzing your entire document system and a vast external referential database in less than 15 minutes.

Maintain your compliance

Set up and maintain your compliance on your own.

Iniscient not only analyzes but also creates a tailored improvement plan based on your priorities and risks. It objectively assesses open-to-interpretation regulations and adapts to ever-changing, non-harmonized, and interconnected compliance requirements, guiding you through compliance hurdles.

Compliance results you can rely on

Iniscient is a fully validated compliance software based on internally developed mathematical concepts. Unlike other tools relying on AI or machine learning, Iniscient remains permanently under the control of the user to provide reliable results.

Economy of Effort

Iniscient streamlines document analysis, reducing the global assessment time from months to minutes and thus liberates resources from administrative tasks to productive activities.

Document kept confidential

At Kernelis Innovation, we prioritize the security and confidentiality of your data by utilizing a secure platform. Iniscient is made available as a SaaS product on MS AZURE and ELCA Cloud system ensuring the analysis of all customer documents in a safe and confidential environment.

Prepare your audit anytime, anywhere!

Iniscient enables real-time evaluation for any organization, accessible online from anywhere. Iniscient can analyze Document System written in multiple languages.

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Offer faster and more valuable services with Iniscient. We assist in streamlining your document analysis process and prioritizing improvements, enabling you to compete confidently on price and quality.

Are you a compliance consultant looking to stand out in a crowded market?

Contact

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