Maggie Bari Email & Phone Number

Fargo, North Dakota Area

Author and update the Computer System Validation polices and procedures. Consult on the update to the Master Validation Plan and Software Inventory.

Austin, Texas & San Diego Ca

➢ Served as Software Quality Assurance and authored initial validation documentation for SLIM (Stability Lab Information Manager). After project restructuring, led the SLIM validation effort to a successful launch. Served as System Administrator during the validation process.➢ Managed the qualification of the TransPerfect’s Trial Interactive clinical software service and developed workflow diagrams and validation plan, procedures, and summary report. Conducted supplier audit of validation policies and procedure.➢ Authored validation documentation for Veeva the company’s new electronic Document Management System (QualityDocs Vault). Performed software risk assessment and Part 11 assessment. Conducted supplier audit of validation policies and procedure. Authored Training materials. Served as Software Quality and System Administrator during the validation process.➢ Authored the company level Computer System Validation SOPs based on GAMP 5 standards. Topics included validation process and deliverables through the software life cycle, software change control, global user name and password management. Created assessment forms and supporting templates.

Greater San Diego Area

Served as Software Quality Reviewer Team Lead for Diagnostic products, manufacturing equipment and laboratory instruments. Partners with Validation Engineers to ensure compliance to company procedures and Part 11 regulations to ensure new product development. Brought a multi-phase remediation project to closure, ensuring that the manufacturing equipment and laboratory instruments systems were compliant with current corporate standards. CAPA team member for issue with individual System Administration procedures being consistent across the global organization. Updated Part 11 assessment tool, Deviation form, and System Administration Procedure template.

Cincinnati, Ohio Area

Authored comprehensive suite of Software Quality procedures, assessments, and templates. The Software Validation Life Cycle is aligned with GAMP 5 life cycle phases (Concept, Project, Operation, & Retirement). Supporting procedures include Master Validation Plans, Periodic Reviews, and Software Inventory. Specialty procedures include Spreadsheet Validation, Shared System Validation, Statistical Package Calculation Verification and Electronic Records & Electronic Signatures. Simplified existing Risk & Part 11 Assessments. Authored training material on new procedures. Also served as Software Quality Approver for new implementation of SAP. Mentored two graduate Quality Engineers in Software Quality.

Fort Washington, Pa

Computer System Validation Lead ~ Computer System Validation Quality Assurance (Consent Decree)Serving as Delegate representing the Associate Director Computer System Validation Quality Assurance to the consent degree’s computer system validation (CSV) program. Provide counsel and input on both the team and leadership level to the Computer System Validation team within the consent degree team. Participated in “CSV Road Show” hosting a question and answer sessions at the effected sites. Analyze sister department’s SOPs to resolve conflicts and align with the newly upgrade CSV SOPS. Worked with Training Team on developing new CSV training curriculum. Reviewed and provided feedback on training materials. Delivered training on the new Spreadsheet Verification and Validation SOP. Reviewed and approved the supporting templates for CSV SOPs developed by consent degree team. Reviewed and commented on the three additional supporting CSV SOPs developed by the consent degree team. Authored white paper on McNeil’s approach to computer system validation. Developed departmental performance metrics.

Fort Washington. Pa

Developed suite of 17 CSV foundational SOPs; including updating the existing 6 core validation lifecycle SOPs, authored supporting and specialized SOPs. Worked with Associate Director of Computer System Validation Quality Assurance and Quantic mentor to ensure alignment with overall vision and compliance with company standards and health authority regulations. Conducted multi-site review sessions to gather feedback from the three affected sites. Selected and interviewed additional team members. Authored team’s project plan.

Quincy, Ma

Led the validation effort of the site’s implementation of a robotic warehouse automation system. Developed the validation strategy for the two work streams, authored test plans, provided expert guidance to vendor on the 21 CFR Part 11 design requirements. Created Validation Abstracts for each of the system’s functional areas which contained testing strategies for each business requirement. These abstracts were the basis for the team of Validation Engineers to draft the Installation and Operational Qualification protocols. Assembled the high-performing Validation Team of nine professional Validation Engineers and Technical Writers. Served as Liaison with site’s Quality Department and Corporate Software Quality Assurance and facilitated issue resolution. Authored and maintained team’s project plan. Developed metrics and provide weekly updates to the Project Team and daily updates to the site’s Senior Leadership Team during periods of testing.

Spencer, In

Managed the Legacy Software Remediation project for the Spencer Indiana site. Lead an international team of twelve assessing and remediating Quality System software and manufacturing systems. Also consulted on 21 CFR Part 11 compliance concerns, change control, and current validation efforts. Authored new and updated existing site SOPs, software testing guidelines and test execution training.

Quincy, Ma

Remediated legacy Quality System software; conducted internal software audit; and advised potential vendor on installation of a Quality System. Also consulted on 21 CFR Part 11 compliance issues.

French Valley, Ca

Managed the Qualtiy Systems (CAPA and NCR) as this site prepared for closure. Conducted Internal Audits for compliance to 21 CFR Parts 820 and 11, ISO 13485, and Canadian regulations. Managed the implementation of Quality System corrective actions based on internal audit findings. Prepared and presented Quality System information for monthly Management Review meetings. Served as site Software Quality Advisor for legacy software remediation projects. Reviewed, commented, and approved all software-related change requests.

Mountain View, Ca

Developed and maintained multi-year, three-phase project plan (schedule), the project’s quality plan, and management presentations on the validation remediation of the site quality system and production legacy system. Recruited and interviewed resources for Legacy Remediation project. Facilitated team collaboration on project deliverables. Developed deliverables summary flowchart as communication tool for management team. Served as site Software Quality Advisor consulting on all new and legacy software projects. Implemented major upgrade of site Software Change Control SOP and supporting forms. Consulted on development of system Security SOP. Developed site software test protocol template and Test Author & Tester guidance training document. Served as liaison to sister site and corporate partners on parent project.

Spencer, In

Managed the Endoscopy CAPA portfolio during the implementation of the upgraded CAPA process. Brought eleven open legacy CAPAs to closure by facilitating the execution of CAPA plan through working with all levels of people, from the Plant Manager to Production Line Operators. These project's goal was to have all open CAPAs within the newly established departmenal goal and this project team acheived it on schedule.

Murrayville, Pa

Authored requirements document for new multi-site CAPA management system. Consulted with Senior Corporate personnel on system architecture requirements. Conducted analysis of potential software solutions from a variety of national vendors. Consulted on software assessment forms and company SOPs on software validation in equipment and automated systems. Reviewed and updated existing CAPA remediation plan.

Natick, Ma

Conducted key Supplier audits across the country focusing on software and qualtiy systems. Partnered with Suppliers on resolving NCRs and SCARs. Served as Project Manager on Supplier Contract Review project. Authored project plan. Coordinated team member’s training and work assignments. Sat on Steering Committee that reviewed results and ensured consistency across the review team. Analyzed data and reported back to the management team. Facilitated the implementation of the new Supplier Control initiative. Conducted risk-based, product-focused assessments at key supplier sites, authored assessment findings reports, and worked with Suppliers to address findings Recruited team members and coached them in new Supplier Control process.

Maple Grove, Mn

Served as Senior Software Quality Engineer on the development and launch of multi-station automated catheter manufacturing lines. Reviewed, commented, and approved document deliverables for all phases of a robust System Development Life-Cycle (SDLC) as part of a rigorous validation effort.Authored related training and deliverable templates still in use by the client company.

Groton, Ct

Doctor Of Business Administration, Finance

Ms Coursework, Accounting

Bachelor Of Science In Business Administration, Accounting