| • GAMP4
Based Validation and USFDA 21CFRPart11 compliance:
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Epitome
provides third party validation services for ascertaining
that the Automation System is Designed / Installed / Operated
in the prescribed manner and any non-conformance be reported
for corrective action. This being a mandatory requirement
for Pharmaceutical Industry, mainly in export centric manufacturing,
Epitome has specialized in providing protocols based on
GAMP 4 guidelines. Epitome has carried out number of projects
with some of the top pharmaceutical companies in India.
The areas covered are as under.
|
• PLC/DCS Validation
• Laboratory Computerised
Systems Validation including SAS validation
• BMS
Automation System Validation
•
Excel sheets Validation
• Electronic Documentation
System Validation
• ERP software validation
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| |
| |
| • SAP
R/3 Validation: |
Epitome has carved out a niche in providing
complete validation solution for SAP R/3 software validation
taking care of preparation of Validation Master Plan, Risk
Assessment, Installation Qualification, Operational Qualification,
Performance Qualification and Validation report.
SAP can be considered as a commercial off-the-shelf
software (COTS) application, with configuration and customization
capabilities. SAP business processes are based on industry
best practices but business operations that differ from those
provided by SAP require configuration and customization.
Regulatory agencies require such customized
cGMP critical material movement as part of audit purview.
Epitome specializes in providing documentary evidence for
compliance of implemented SAP R/3 system configuration as
per US FDA, MHRA etc requirements. The basic approach involves
detailed gap analysis and risk assessment methodologies to
identify overall validation strategy as well as risk mitigation
approach. This also involves impact analysis and compliance
solutions to meet USFDA 21CFRPart 11 requirements.
|
| |
| • BMS
Automation |
BMS Automation Systems are evolving. The
driving force behind this evolution is the need to add value
to the customer’s organization. In the past, the focus
was on features such as the hardware or networks. The current
focus is on benefits. Hardware and networks are only a platform;
the benefits come from software applications. The future focus
of BMS Automation Systems is on solutions.
From Epitome we provide Total Solution from
design, engineering, supply, installation, testing, commissioning
and training for plantwide BMS system. Our rich experience
in regulatory compliance, software validation and USFDA 21CFRPart
11 compliance, add direct value to our clients in meeting
International regulatory requirements.
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