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Software Application Development
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USFDA CFR11 Compliance
Audit Trail & Reports
Hardware Integration
Application Protection
SOP building
Application Validation
BCP & DRM Documentation
Services
The software development process has an essential component of testing. Various levels of testing are used as per
the accuracy requirements and tolerances. Standard testing approach are maintained at almost all software application
development firms.
One of the highest levels of accuracy and testing compliance are achieved through Validations. These testing and standard
Development requirements are defined by the International audit agencies like USFDA
(United States Food & Drug Administration), ANVISA (Brazil), MHRA
(Medicines and Healthcare products Regulatory Agency, UK), Audit Agencies of France, Germany, Turkey as well as the office of the
DCGI (Drug Controller General of India). These standards are essential for software products used in Life Sciences. As
human beings are involved as drug testing volunteers the accuracy of the software application is the prime concern.
Our applications decide whom to give medicine dose and whom not to. Further the lifetime unique identification number
is also assigned from the same product. The results and follow up drug dosing as well as human identification are very
critical steps. This criticality compels us to follow the Validation Standard CFR11 of USFDA.
Inforcom products have undergone over 25 Compliance validation process across India at various CROs.
We offer service to generate the validation document. Besides the standard testing and documentation, the validation
documentation is a detailed procedure to check each step of each function and object in the application. The complete
process requires IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) as
well as the Overall Plan of the same. The routine functionality of each control is tested under the OQ, while the
erroneous input error tracking and handling – the challenges and response are tested and documented under PQ. Further we
carry out the validation process at the client machine. This is accompanied with numerous screen prints for each step of
the validation script.
Inforcom offers products and application development with Audit Trails. Audit Trails record the operations in terms of
its occurrence, author and the details. These information is collected during the data entry as well as the data edit /
change time. The details mainly involve the date, time, Location as well as the name of the person carrying out the entry
/ change. Further the reason for the change in an important data for the audit purpose.
The validation offers a perfect product with detailed functional testing and documentation.
The software development process has an essential component of testing. Various levels of testing are used as per
the accuracy requirements and tolerances. Standard testing approach are maintained at almost all software application
development firms.
One of the highest levels of accuracy and testing compliance are achieved through Validations. These testing and standard
Development requirements are defined by the International audit agencies like USFDA
(United States Food & Drug Administration), ANVISA (Brazil), MHRA
(Medicines and Healthcare products Regulatory Agency, UK), Audit Agencies of France, Germany, Turkey as well as the office of the
DCGI (Drug Controller General of India). These standards are essential for software products used in Life Sciences. As
human beings are involved as drug testing volunteers the accuracy of the software application is the prime concern.
Our applications decide whom to give medicine dose and whom not to. Further the lifetime unique identification number
is also assigned from the same product. The results and follow up drug dosing as well as human identification are very
critical steps. This criticality compels us to follow the Validation Standard CFR11 of USFDA.
Inforcom products have undergone over 25 Compliance validation process across India at various CROs.
We offer service to generate the validation document. Besides the standard testing and documentation, the validation
documentation is a detailed procedure to check each step of each function and object in the application. The complete
process requires IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) as
well as the Overall Plan of the same. The routine functionality of each control is tested under the OQ, while the
erroneous input error tracking and handling – the challenges and response are tested and documented under PQ. Further we
carry out the validation process at the client machine. This is accompanied with numerous screen prints for each step of
the validation script.
Inforcom offers products and application development with Audit Trails. Audit Trails record the operations in terms of
its occurrence, author and the details. These information is collected during the data entry as well as the data edit /
change time. The details mainly involve the date, time, Location as well as the name of the person carrying out the entry
/ change. Further the reason for the change in an important data for the audit purpose.
The validation offers a perfect product with detailed functional testing and documentation.
The software development process has an essential component of testing. Various levels of testing are used as per
the accuracy requirements and tolerances. Standard testing approach are maintained at almost all software application
development firms.
One of the highest levels of accuracy and testing compliance are achieved through Validations. These testing and standard
Development requirements are defined by the International audit agencies like USFDA
(United States Food & Drug Administration), ANVISA (Brazil), MHRA
(Medicines and Healthcare products Regulatory Agency, UK), Audit Agencies of France, Germany, Turkey as well as the office of the
DCGI (Drug Controller General of India). These standards are essential for software products used in Life Sciences. As
human beings are involved as drug testing volunteers the accuracy of the software application is the prime concern.
Our applications decide whom to give medicine dose and whom not to. Further the lifetime unique identification number
is also assigned from the same product. The results and follow up drug dosing as well as human identification are very
critical steps. This criticality compels us to follow the Validation Standard CFR11 of USFDA.
Inforcom products have undergone over 25 Compliance validation process across India at various CROs.
We offer service to generate the validation document. Besides the standard testing and documentation, the validation
documentation is a detailed procedure to check each step of each function and object in the application. The complete
process requires IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) as
well as the Overall Plan of the same. The routine functionality of each control is tested under the OQ, while the
erroneous input error tracking and handling – the challenges and response are tested and documented under PQ. Further we
carry out the validation process at the client machine. This is accompanied with numerous screen prints for each step of
the validation script.
Inforcom offers products and application development with Audit Trails. Audit Trails record the operations in terms of
its occurrence, author and the details. These information is collected during the data entry as well as the data edit /
change time. The details mainly involve the date, time, Location as well as the name of the person carrying out the entry
/ change. Further the reason for the change in an important data for the audit purpose.
The validation offers a perfect product with detailed functional testing and documentation.
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