Partner Member of Medicine for Europe

Codema Pharma
IT Technologies Evaluation Process

An Evaluation Criteria Based Approach Developed by Codema Pharma

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Codema: Setting High Evaluation Standards

Codema Pharma (Codema) is an independent rating company helping pharmaceutical and life science
companies evaluate their supply chain and meet the latest industry requirements. The company serves
innovators, manufacturers and suppliers of medicinal drugs, active pharmaceutical ingredients, medical devices
and cosmetic products.
Since its foundation in 2009, Codema positioned itself as the preferred rating partner and advisor to European
regulators and authorities, actively contributing in defining harmonized criteria for the evaluation of
pharmaceutical supply chains. This gave Codema a unique insight into regulatory, quality and compliance,
based on which, the company developed evaluation systems, processes and protocols.
Codema’s world-class experts and auditors successfully support customers asses complex and critical data,
identifying gaps and risks, while optimizing time and resources. Codema strives to improve the dialogue
between companies, regulators and suppliers and it is proud to contribute ensuring the highest levels of safety
and quality for pharmaceutical products and active ingredients.

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Our History
▪ 2009: Codema develops Evaluation Protocols to assess quality and compliance across the pharmaceutical supply chain.
Codema plays a pivotal role in the e-classification of pharmaceutical standards endorsed by the European Committeefor
Standardization (CEN) and developed in collaborations with experts from the EMA, ICH and EDQM.
▪ 2010: Codema teams up with the EDQM on theapplication of the Regulation (EC) No 1272/2008 of
the European Parliament on “classification, labelling and packaging of substances and mixtures.”
▪ 2015: Codema’s systems and programs for the evaluation of the pharmaceutical supply chain is recognized by the China
Chamber of Commerce CCCMHPIE, one of the leading and most influential national trade association in China.
▪ 2017: Codema establishes its offices in Brussels and launches its “Rating Program EvaluationSystem”
▪ 2019: Codema is a partner member of Medicine for Europe, a sector group representing the generic medicines
developers and manufacturers. Codema is an active member of the Working Group “Quality and Compliance” and
develops a risk-based approach to evaluate the risk of nitrosamine impurities s in DPs and APIs as required by EMA.
Codema initiates a dialogue between Medicine for Europe and the CCCMHPIE on regulations for APIs
manufacturing and global supply chains.

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What We Do For Our Customers
▪ Protocols development to be apply to all providers
and relevant IT architectures concerning services
provided (or to be provided) within the
pharmaceutical industry
▪ Codema’s well-defined protocols are:
✓Based on evaluation criteria in order to assess
suitability of IT architectures used for providing
services
✓Exhaustive and compliant with the latest
regulatory requirements for the Pharma
Industries’ peace of mind
✓Easily implemented by the IT company with
minimum training, often done remotely
Codema Pharma - IT Technologies Evaluation Process - Confidential
▪ We partner with our customers and contribute to
their success by:
✓A valid and efficient process of evaluation
✓Evaluating complex and critical data
✓Identifying gaps and risks
✓Optimizing the time and resources involved in
the evaluation process
✓Meeting regulatory requirements
▪ We are proud to offer to our customers:
✓Unparalleled access to world-class experts and
auditors in regulatory, compliance and IT
technologies
✓Best practices to comply with Pharma industry
standards
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Codema Evaluation Process in IT sectors

A group of expert
IT Company already
from IT companies and
present or potentially
Pharma industries
Codema IT IT interest in pharma
application
Working Group
Company

levDifferentels of Codema
evaluation, based on
Evaluation Codema Protocol IT Technologies Protocols
information received
RP2100 Series: Blockchain Technologies
through the protocols Application RP2200 Sewries: Cloud Computing
RP2400 Artificial Intelligence
Pharma Sector
requirements

Regulatory - Quality - Compliance

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 Codema Evaluation Process: Our protocols for different life science sectors

Codema Codema Codema Two

Evaluation Protocol Evaluation deliverables
Process Report for a full
evaluation

Pharma
Medical Devices & Cosmetics
RP500 Series: Evaluation of GDP Compliance
RP300 Series: Preliminary Evaluation of
RP600 Series: Evaluation of Pharma Analytical
Information on MedicalDevices
Test Laboratory
RP700 Series: Information on Active
RP400 Series: Information on Cosmetic Raw Pharmaceutical Ingredients Evaluation
Material
RP800 Series: Information on Financials And
Governance
RP890/RP 891 Series: Nitrosamines Risk
Assessment
Codema Pharma - IT Technologies - Confidential
 Codema Evaluation Process Scheme

▪ Codema standardized process allows to quickly manage, assess, IT and ICT Technologies
update and compare the huge amount of data for each IT
Technologies IT Company
▪ Evaluation protocols are designed to be easily implemented and/or
integrated by IT company as new data become available Implementation of Protocol
▪ Competent auditors CAE duly acknowledged by Codema (Codema
acknowledged Expert Application) shall carry out relevant
verifications and testing according to the criteria and requirements
Codema Pharma
provided in the protocols
▪ Auditors from pharma sector and IT sector will cooperate to draft
an Evaluation Report, based on specific area of evaluation Assessment by CAE
▪ The evaluation issued by Codema on the grounds of the based on 5 Area of
information collected through the protocol will serve pharma Evaluation
companies in better assessing the providers
Evaluation Report
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 IT Technologies Protocols & Levels of Evaluation

IT Technologies Protocols Levels of Evaluation

✓Designed as ‘open document’ Level 1 (Light Evalution):

✓Allowing IT companies to include comments for ▪ No attachment to be provided
each individual section ▪ Easy protocol implementation (YES/NO answer)
▪ Addition of comment is possible
Level 2 (Complete Evaluation):
Protocol Nr Target
▪ Attachments and technical documentation to be
RP2100 Series Blockchain Technologies provided
RP2200 Series Clouding Computing ▪ Protocol implementation with comments
Level 3 (Peer Evaluation):
RP2300 Series IOT Services ▪ Evaluation by a third part expert of all
RP2400 Series Artificial Intelligence documentation provided by IT company and
Codema evaluation

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Project Management

A defined structure of
Seamless and fruitful
implementation and a clear
collaboration with IT Companies
assignment of responsibilities

PLANNING EVALUATION REPORTING

▪ IT Technologies to be ▪ Data Management and ▪ Implemented Protocols
Evaluated Assessment ▪ Integrative Documentation
▪ Confidentiality ▪ Codema Protocols supplied by IT Companies
▪ Data Management Implementation ▪ Revision of Evaluation Report
▪ Contract Definition ▪ Evaluation Process including ▪ Final Evaluation Report
▪ Kick-off Meeting • Revision by Expert
▪ Training • Quality Control
• Evaluation Reports

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The Evaluation Process Step by Step

STEP 1 STEP 2 STEP 3 STEP 4 STEP 5

Protocol Protocol Filled by The filled form Green light by IT Evaluation by
provided by IT Company sent to Codema company to the recognized experts
Codema (toghether with all evaluation by CAE & Final Evaluation
documentation if Expert Report Release
necessary)

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 Partner Member of Medicine for Europe

Codema Pharma S.A.

Clos Chapelle-aux-Champs, 30
B-1200 Brussels, Belgium
info@codemapharma.com
www.codemapharma.com

We look forward to helping you to assess your IT technologies

for Pharma application

LEGAL CLAIMS
The structure of the evaluation process and organization of contents, method of procedures of protocols of
evaluation constitute exclusive intellectual property of Codema Pharma S.A. (Codema). Codema IT Technologies
Project has been entirely developed by Codema and exclusively belongs to Codema.

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