Consistency meets competency

Our corporate philosophy is grounded in the word ‘quality’. We apply best practices along with standardized processes for consistent delivery of high- quality data without compromising on cost and time efficiencies.

Validation process for EasyCDM Suite:
Installation Qualification (IQ):

The Installation Qualification IQ is the documented proof that facilities/equipment/software have been delivered and installed in accordance with the requirements and statutory safety regulations stipulated in the design qualification. The documentation for an Installation Qualification normally consists of:

IQ test plan: Contains detailed information of the tests to be performed on the respective equipment/software in the context of the Installation Qualification.

IQ report: After completion of the Installation Qualification IQ, the results are summarized, evaluated and compiled in an IQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new IQ report.

Operational Qualification (OQ):

The Operation Qualification OQ is a test process that evaluates the correct functioning of a facility or an appliance. During the Operation Qualification OQ, all items specified in the test plan are processed and documented in writing, to ensure that the system functions in accordance with specifications. Tests in accordance with the OQ can under some circumstances (otherwise only normal for the Performance Qualification PQ) only be performed with a loaded chamber. The (successfully) performed Operation Qualification OQ is a prerequisite for the technical acceptance of a facility or appliance. The Operation Qualification OQ may only be performed after a successfully completed Installation Qualification IQ. The documentation for an Operation Qualification normally consists of:

OQ test plan: Contains detailed information of the tests to be performed on the respective equipment/software in the context of the Operation Qualification OQ This test plan contains detailed specifications on the course of the test itself.

OQ report: After completion of the Operation Qualification OQ, the results are summarized, evaluated and compiled in an OQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new OQ report.

Performance Qualification (PQ):

Performance qualification (PQ) is an important component of the validation of the entire production process over a certain period of time and for a specific product. Its purpose is to verify and document that the system and processes are working reproducibly within the entire specified working range and limits. The systems are not inspected individually but always as part of the overall or partial process. Even though PQ usually comprises OQ tests under process conditions a detailed test plan has to be created based on a comprehensive process description before the validation process is started in any case.

Regulatory compliance:

  • FDA 21CFR Part 11
  • GCDM

How do we set the standard for delivering data quality?

  • Precision – Expert CRF and database design promotes accurate data collection for clean, reliable data.
  • Speed – Advanced data management technology means your database can be in production in as few as 6-8 weeks.
  • Proactive service – Our project management methodology fosters efficiencies, allows for early problem solving and reduces oversight time.

List of SOP’s

  • Project plan
  • Quality Management
  • EasyCDM Suite study configuration
  • Data entry
  • Medical coding
  • Study testing
  • Change control management
  • Data extraction and transfer
  • Quality control
  • Database lock
  • Medical dictionary installation and upgrade
  • User Management and admin
  • Back-up & restoration
  • Receiving and loading external data
  • EasyCDM Suite installation set-up
  • Software patch installation

List of Validation Documents

  • Functional requirements of EasyCDM Suite– Clinical Trial Solution.
  • Installation Qualification of EasyCDM Suite– Clinical Trial Solution.
  • Installation Qualification Test Plan of EasyCDM Suite– Clinical Trial Solution.
  • Installation Qualification Test Script of EasyCDM Suite– Clinical Trial Solution.
  • Operational Qualification Summary Report of EasyCDM Suite– Clinical Trial Solution.
  • Operational Qualification Test Plan of EasyCDM Suite– Clinical Trial Solution.
  • Operational Qualification Test Script of EasyCDM Suite– Clinical Trial Solution.
  • Performance Qualification Summary Report of EasyCDM Suite– Clinical Trial Solution.
  • Performance Qualification Test Plan of EasyCDM Suite– Clinical Trial Solution.
  • Performance Qualification Test Script of EasyCDM Suite– Clinical Trial Solution.
  • Validation Plan for EasyCDM Suite– Clinical Trial Solution.
  • Validation Summary Report of EasyCDM Suite– Clinical Trial Solution.
  • User Requirement Specifications for EasyCDM Suite– Clinical Trial Solution