Process Automation: As a team, we specialize in
the areas of defining the automation (Control and Instrumentation)
requirements for any given process including Bulk Drug and Biotech manufacturing.
We have successfully completed Process Automation Projects like
Distillation Column Automation, Ozonalysis
Reactor Automation, Enzyme Control, Effluent Treatment Plant as well as
Data Acquisition System for various temperature points in the API plant.
As a part of such projects we undertake turnkey responsibilities
including Engineering, Programming, Supply, Installation, Testing,
Commissioning, Training and Validation of the Automation System.
Computerized System Validation: Computer Systems are used in
the areas of Production ( PLCs,
BMS, SCADA etc. ) and QC & QA ( Lab Instruments like HPLC, GC etc.;
LIMS and the system pertaining to Quality Assurance ). Also the material
management or ERP Software are subject to the
validations. We have carried out various projects meeting the GAMP (Good
Automated Manufacturing Practice) as well as US FDA 21 CFR Part 11
Compliance. These validation documentation have
been audited by international agencies like US FDA, UK MCA, MCC and some
of the international pharmaceutical companies. Having gained rich
experience in these areas, we are confident of undertaking projects on
Computer System validation and meeting with US FDA 21 CFR Part 11
Compliance.
Software Products and Solutions
:
Document Management System: We have joined hands with Master Control, USA, a
leading software company providing FDA based Integrated Quality
Management Suite to automate your overall documentation process.
Validation Protocol Module: We represent CGMP
Systems, USA for their unique Automated Validation Protocol
Generator Software. With help of this software huge amount of time and
resources are saved for creation of various validation protocol
documents.
cGARD: Global Automated Regulatory
Database, developed by Compliance Control, UK
is a software tool that has complete database of USA, EU, Japan,
Canada,
ICH and is continuously being updated to include latest regulations.
It’s a single point stop to find relevant regulation as well as its
cross reference with other such regulation worldwide and its easy to understand explanation.
