BIOPHARMA IT CONSULTING PTE. LTD.

Biopharma IT Consulting is here to help with the increasing IT and Data Integrity demands faced by the Biologics and Pharmaceuticals industry. Our consultants are experienced to support tight schedules with demands for high quality IT deliverables which are compliant to all GxP regulatory agency's (FDA/EMA/TGA/HSA) requirement. The services we provide include technical, IT/QA or Computer Systems Validation and large scale Testing management. Technical 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. 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. Large scale 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. * – All the software and standard names mentioned above are registered trademarks of the respective companies and organizations.