IT QA / Computer System Validations services
Our consultants are key enablers to your critical systems and projects in accordance to your local Quality Management Systems, based on the GAMP5* and ISA-95* standards.
We have in-depth experience authoring high-quality deliverables like Validation Plan, Data Integrity Assessment, Design Specifications, Installation Qualifications, Operational Qualification, Testing Protocols, Performance Qualification and Validation Summary Report across different systems and platforms.
To ensure continued “Validated” status of the systems, on-going change management, access management and periodic reviews must be conducted. Our consultants are experienced in performing these support tasks for different systems and platforms.
System Testing planning, execution and management services
Our consultants have in-depth handson experience with HP Application LifeCycle Management (ALM)* tool to support manual testing with electronic records that would be FDA CFR Part 11 compliant.
We are also experienced with large scale testing and management effort from planning to execution and overall management of any large scale testing efforts.
Technical support services
Our consultants have in-depth handson experience as part of the technical implementations team to deliver the following systems and platforms.
ERP System: SAP* Production Planning, Production Execution, Quality Management modules.
Manufacturing Execution Systems: AspenTech IP.21*, Batch.21*, Werum PAS-X*.
Data Historian: OSI-Soft PI Data Historian*.
Lab systems: Waters CDS Empower* and Sample Manager LIMS.
* – All the software and standard names mentioned above are registered trademarks of the respective companies and organizations.