Mohana Vakkalagadda

Projects: Callidus, PDT Canada, LIMS, Veeva, MetCal, iEnvision, Windchill, Loftware, Jira DC, Informatica UDI, Grand Avenue Decom, Parylene Interface.

• Lead review and approval of all SDLC deliverables including MVP, Risk Assessments, URS, FRS, IQ/OQ/PQ, and System Certification documents.
• Supported the implementation of Medical device systems like PDT Canada, LIMS, Veeva, Vaisala, MetCal, iEnvision, Callidus, Loftware.
• Supported implementation and validation of several regulated IT systems (Document Management, Lab Systems, ERP modules).
• Authored and reviewed Traceability Matrices ensuring end-to-end requirement coverage and test evidence.
• Performed FMEA and other risk-based analyses to guide testing and documentation strategy.
• Collaborated with cross-functional teams to embed quality checkpoints into Agile and Waterfall SDLC workflows.
• Provided validation and quality guidance to technical and project teams to ensure compliance to the regulations like 21 CFR Part 11, GDP and GMP.
• Reviewed and approved Validation Master Plan (VMP) in accordance with company SOP and provided quality guidance.
• Reviewed UAT/DRY RUN/OQ/PQ protocols by identifying high and medium risk requirements and developed appropriate test strategies.
• Involved in reviewing and approving test and validation summary reports.
• Involved in reviewing and approving of Validation deliverables Risk Assessment, part 11 assessment, Operational Qualification/ Performance Qualification, and Requirements Traceability Matrix.
• Managed and approved execution/verification of evidence of OQ and PQ tests.
• Experience in performing Periodic Review, Change Control management, and Risk analysis, FMEA process.
• Reviewed risk management assessment on all systems under validation.
• Reviewed Functional Verification/Validation Testing as per the features of the product/system.
• Performed and approved Vendor Assessments for cloud vendors. Reviewed validation packages provided by the vendors.

Projects: Veeva Vault (QualityDocs, QMS – Multiple upgrades), TrackWise (CAPA, CCM), ServiceNow, SAP ERP

• Worked on validation activities for GxP computerized systems to ensure software applications are accurate, complete and conform to user, company and regulatory requirements.
• Drafted, Reviewed and updated Operation Qualification (OQ) and Performance Qualification (PQ) using HP Quality Center/ALM.
• Worked on ServiceNow platform validation used (connected workflows) for clinical trial, field service, quality and risk management.
• Involved in validation of computer systems according to company policies and FDA regulations.
• Collaborate with Cross-functional teams to ensure timely resolution of Veeva Vaults system issues and for continuous process improvement due to forced vendor upgrades.
• Reviewed and updated the User Requirement Specifications/Functional Requirement Specifications/Configuration Specification documents .
• Reviewed validation documents as per company’s SOP and standards: Validation Plan, Risk Assessment (Overall and Requirements level), Requirement Traceability Matrix (RTM), Summary reports.
• Manage, document, and implement upgrades through Changes Control procedure.
• Reviewed Standard Operating Procedures (SOPs) for the operational maintenance and for the Business Continuity from compliance and validation standpoint.
• Reviewed Functional Requirements from User Requirements and User stories with the Business Analyst
• Responsible for the validation of Electronic Records (ER), Electronic Signatures (ES) and Audit Trails in accordance with 21 CFR part 11 regulations.

Projects: Veeva Vault (QDocs, QMS, Audit, Supplier Quality), LabWare LIMS, Werum MES (Manufacturing Execution System), Salesforce.

• Reviewed and Approved the formal validation and test documentations – Validation Plan, Test plan, test activity road map, traceability matrix (post test execution), Risk Assessment (Overall and Functional), ERES/21 CFR Part 11 assessment, Operational and Performance qualification test scripts, Test and Validation Summary Report.
• Involved in reviewing Corrective Action and Preventive Action (CAPA) documentation.
• Performed the dry run of the test cases of the COTS and configured applications.
• Attended the configuration meetings for setting up the workflows at study/country/site level documents and its lifecycles.
• Analyzed the test data for dry run and formal test execution for functional and user acceptance testing for different phases.
• Reviewed URS, FRS, DS documents from validation/quality stand point and provided feedback to the project teams.
• Reviewed and approved the user acceptance testing scenarios and test scripts for formal test execution and promoted those for approvals using HP ALM.
• Developed the high level and detailed level process maps in defining the use cases for documenting the test scenarios and test scripts.
• Drafted and provided input on the mapping and configuration document, functional specifications, change management in user requirements prior to test execution.
• Conducted various types of testing: User Acceptance Testing Dry runs, Regression Testing, Positive Testing, and Negative Testing using HP ALM.

Projects: JD Edwards, Argus Safety (Drug Safety project), CTMS, Sharepoint EDMS.

• Responsible for working with the vendor on Drug Safety Project validation (Argus Safety).
• Used HP ALM for requirements and test management activities.
• Reviewed and updated Operation Qualification (OQ) and Performance Qualification (PQ) using HP ALM.
• Reviewed and approved IQ/OQ/PQ test scripts, defects and incident reports.
• Reviewed and updated Data Migration strategy for migrate the data from legacy systems into CTMS.
• Reviewed and Approved the following deliverables – Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ , Validation Summary Reports, Gap Analysis/Remediation plans,
• Maintained CAPA procedure, initiated investigation of non-conformances through root cause analysis (RCA), evaluation of the effectiveness of CAPA process, and initiation of action as required improving effectiveness.
• Performed change control and managed the entire change management process with business, technical and quality persons.
• Reviewed, coordinated and maintained CSV Change Controls. Prepared Periodic Reports for outstanding Change Controls.
• Reviewed Functional Specifications, Design Specifications, User Manuals, System Procedures, System Description and Training records
• Drafted new SOP’s and trained all users on the systems, implications and impact of 21 CFR Part 11 compliant data systems on day-to-day functions.
• Wrote and executed test scripts based on the test plan and in accordance with Good Documentation Practices (GDP).
• Worked with testing team to manage the entire testing life cycle.
• Reviewed Operational Qualification test scripts for ERP implementation.

Projects: Electronic Document Management System (Sharepoint), Bioclinica Clinical Trial Management System (CTMS), SAP ERP (QM, MES workflows).

• Developed validation strategy to validate Document Management (EDMS) Documentum application according to company standards and procedures/
• Developed Data Migration Strategy to migrate data from legacy system to Documentum.
• Followed the SDLC in all stages of the project to develop validation deliverables including Validation Plan and Validation Summary Report
• Experience in Data Migration, Periodic Review, Change Controls, and Risk analysis, CAPA, FMEA and Remediation Process
• Analysed business requirements and functional design documents to prepare Validation Plan to define objective, scope and validation strategy of the project.
• Developed the Test Execution Guidelines to train the business users to execute the scripts as part of UAT.
• Prepared SFT (OQ) and UAT (PQ) test scripts.
• Used HPALM/HPQC to author and execute test scripts.
• Developed the test scripts to test the Security User Profiles and Audit Trail to meet the Part 11 regulations.
• Authored and tracked Defects in HPQC/ALM.
• Created Trace Matrix and Validation Summary Report.