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 26574407Email-ID: sales@epitome.co.inurl : 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 ValidationERP (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 QualificationThe 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 SupportEnsuring 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 ServicesEnsuring 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 ApproachProgram 2 : GAMP5 Approach and DocumentationProgram 3 : Achieving and Maintaining 21 CFR Part 11 ComplianceProgram 4 : Achieving and Maintaining Data IntegrityProgram 5 : Part 11 Compliance for MS Excel SpreadsheetsProgram 6 : Two Days – Training-cum-workshop Programme on ERP System (SAP) Validation.Program 7 : Two Days – Training-cum-workshop Programme on Process Control System ValidationProgram 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 AttentionSincerely Yours