Ingenico Technologies

Corporate Office:

A-415, ATMA House,

Nr. Times of India Building,
Opp. Old RBI, Ashram Road,
Ahmedabad-380009. Gujarat. INDIA.
Phone: +91 79 26578569/ 79 26574407
Email-ID: sales@epitome.co.in
url : http://www.epitome.co.in
 Ingenico Technologies
 For Over 15 years as part of Epitome Technologies Has
been Providing Computer System Compliance Solutions
to Life Science Industry
 Located in Western Part of India has Clients all across
India as well as Other countries such as UK, Canada,
Germany, South Africa, Dubai, Egypt, Bangladesh,
Saudi Arabia etc
 Highly Impressive Track Record of Completing
Compliance Projects and Data Integrity Remediation
 Many successful CSC Training programs
 Services
 Compliance and Computer System
Validation Support for
•Process control Validation
• Laboratory Computerised System
Validation
• ERP Validation ( SAP validation)
•IT Infrastructure Qualification
• US FDA 21 CFR Part11
Assessment. EU Annx 11
compliance
•Lifecycle Management
 CSV and Compliance Training
• GAMP5
• 21 CFR Part 11 & Annx 11
• Data Integrity Compliance
• Automation for Compliance
 CSV and Data Integrity
Audit/Assessments
• 21 CFR Part 11 Assessment
• Data Integrity Assessment
• GAMP 5 validation Assessment
• Remediation Plan
 Vendor Assessment
 IT documentation
• SOPs
• Policies
• QMS
 Compliance and Computer System
Validation

We partner with our clients, working with them to define the road to
compliance within their environment. At the heart of our services is a
thorough understanding of compliance. We have an in-depth understanding
of international regulations such as US FDA 21 CFR Part 11 as well as EU
Annexure 11 and assist our clients in staying up to date and responding to
the latest developments in regulatory compliance. Our well-defined
structured methodology and approach follows best industry practices and
complies with all international agency requirements. We follow
internationally accepted GAMP 5 guidelines and its current interpretations
for validation of computer systems applying Risk Based Approach and Life
Cycle Management philosophy.
 Process Control (PLC/ SCADA / BMS)
System Validation
Manufacturing involves various types of automated equipments,
including PLC, SCADA, BMS, DCS etc. We take care of all types of
process control system validation making sure that CSV documentation
are integrated with equipment vendor’s documents & your QMS
practices, avoiding repeat documentation.
 ERP/SAP Validation
ERP (e.g. SAP ) system is used to handle material related transactions at
the various stages of Manufacturing right from requisition of the raw
material till dispatch of finished goods. Some of the operations being
cGMP transactions, it is imperative to validate this system and software
prior to their diplomat for handling these transactions. We have
experience in handling all types of ERP systems and chiefly SAP system
validation relevant to pharmaceutical operations.
 Laboratory Computerized System
Validation
Laboratory analysis and data generation is dependent in high-end
software. Data integrity is crucial to prove in all laboratory analysis.
Data falsification and fabrication claims cause doubt on the overall
integrity and validity of the work reported in a company. We can take
care of your such concerns and provide full compliance
documentation.
 IT Infrastructure Qualification
The IT Infrastructure exists to support the primary business, by
providing Platforms to run the business applications (e.g. ERP, CDMS,
LIMS) and processes that facilitate a capable and controlled IT
environment. EU annexure 11 amongst other specify need to qualify
your IT infrastructure. We can help your IT team in understanding
the requirement and creating a controlled environment with
necessary documentation.
 LifeCycle Management Support
Ensuring compliance for the computerized system is proving to be
more challenging task after validation of such systems. Often due to
lack of proper SOP driven and review driven approach, major errors
creep in validated system during their lifecycle. We provide services to
ensure that all your computerised systems Validated Status is
maintained throughout their life cycle, giving you peace of mind to
focus on your core expertise area.
 Audit /Assessment Services
Ensuring compliance for the Computerised Systems and Software
validation as per expectation of International regulatory is very
involved task. However even more challenging task, after first
validation of such systems is to maintain their “Validated Status” and
be prepared before important Audit and making sure that all
computerised system validation practices and documentation are upto
date.
We can assist you in assessing your computer system compliance
practices. Our assessment covers
• GAMP 5 Validation documentation
• Data Integrity Requirements/Part 11 requirements
• LifeCycle Management
 Vendor Assessment
Vendor plays crucial part in maintaining compliance for your company.
Selection and assessment of vendor was never more important as they
are becoming more of a partner then only system/service provider. We
can assist you in creating a comprehensive Vendor Assessment program
for all your computer system/software vendors including third-party-
audit.
 Computer System Compliance Training
Programs
Computer Systems Validation (CSV) is all-pervasive in the Life
Sciences Industry. It is a requirement of all the predicate rules, as
well as US FDA 21 CFR 11 and EU Annex 11. However, unless one
knows how to implement CSV, it is often very hard to detect the
requirement for CSV, and very hard to determine what needs to be
done, to meet domestic and / or international
regulations or business continuity requirements.
Epitome Technologies, with its rich experience of CSV &
Compliance, has designed Training Programs to bridge this gap.
These programs help the Executives to better understand the basic
framework for CSV, expectations of regulatory agencies and CSV
documentation following GAMP5 guide. It addresses the key
requirements for the data integrity and how to implement
strategies for US FDA 21 CFR Part 11 and EU Annexure 11
compliance.
 Computer System Compliance Training
Programs
Program 1 : Computerised System
Validation Overview and Approach
Program 2 : GAMP5 Approach and
Documentation
Program 3 : Achieving and
Maintaining 21 CFR Part 11
Compliance
Program 4 : Achieving and
Maintaining Data Integrity
Program 5 : Part 11 Compliance
for MS Excel Spreadsheets
Program 6 : Two Days – Training-
cum-workshop Programme on ERP
System (SAP) Validation.
Program 7 : Two Days – Training-
cum-workshop Programme on
Process Control System Validation
Program 8 : Two days – Training-
cum-Workshop on Laboratory
Computerised and Software System
Validation
We can create customized programs specific to client needs.
 IT Documentation Assistance

In every pharmaceutical organization, role of

IT is becoming increasingly more involved and
crucial for achieving compliance objectives as
most of critical processes are now software
driven. IT depts. are now becoming focal point
of many audits.
We can be your partner for providing ITQA
services. Be it your Computer System
Compliance documents, ISO/ISMS/QMS
documents or SOPs for IT, we can help you in
making sure your practices and
documentation are current and as per best
practices. We help your IT dept. to create
their QMS and establish processes so that IT
becomes an integral part of company’s QA
objectives.
Partial List of Clients
Thank You For Your Attention
Sincerely Yours