Services

VSAM Knowledge Solutions Inc – Consulting and Contract Services in IT Pharma

Toronto-based IT Consulting and Contract Services in Computerized System Validation (CSV) and System Deployment.

Experience tends to be a predictor of success, and at VSAM Knowledge Solutions we are proud to have over 20 years of IT consulting and contracting experience in pharmaceutical, vaccine, generics, sterile manufacturing industrial operations. This includes projects completed at large corporations throughout Canada and the US. As a professional engineer and project management professional, our founder Vishal Magoon, PEng, PMP, CSM, PMI-ACP has worked on and managed projects involving compliance, regulatory audit, validation, system administration, and business development.

We Provide Essential Computer Systems Validation (CSV) Solutions

VSAM Knowledge Solutions mission is to provide leadership support through consulting services, exploration, ideation, resource planning and system implementation. We will do so through leadership, communication and transparency to stakeholders, while providing documented compliant, IT application system deployment and solutions to prove it.  We provide a peace of mind to IT Leaders and Business Leaders for Operations and keep them going. We put people first and ensure proper training is provided on new system deployments. Change Management is at our core and ensure compliance is met in highly regulated industries. We increase productivity and we are here to make the customer look good.  Our IT consulting services are essential to the success of any pharmaceutical company, as they allow your company to say what you do, do what you say, and prove it.

PMPs with Experience to Provide Consulting and Contract Services

As engineers and Project Management Professionals we have travelled a long road to get to where we are. Let us help your company get to where you want to go to, too. Our over 20-year career path includes operating in capacities including:

• Principal Consultant
• Program Manager
• Project Manager
• Senior Business Analyst
• Validation Engineer
• Senior Validation Specialist
• IT Application System Administration

At VSAM Knowledge Solutions our services include:

Digital Adoption: Expertise in providing digital adoption plans to leverage digital technologies to reduce manual processes, improve operational efficiency, enhance customer engagement and increase sales.

Program Management: Expertise in provided tracking, forecasting, and resource management for project components in Industrial or ERP portfolios at organizations.

Project Management: Expertise in strategic discovery, initiation, planning, design, development, execution and closeout activities. Project Management Methodologies using Waterfall, Hybrid and Agile frameworks. These deliverables included Project Charter, Project kick-off, Risk Workshop, Work Breakdown Structure (WBS), Capacity Planning, RAID (Risk, Action, Information, Decision) Log, Project change requests, Software Development Life Cycle Gate (SDLC) Deliverables, Sponsor and Stakeholder Project Meetings/Presentations and Lessons Learned.

Business Analysis: Management of equipment/software validation projects, including Validation Plans (VPs), User Requirement Specifications (URS), Functional Specifications (FS), Hardware/Software Design Specifications (DS), Traceability Matrix (TM), Installation Qualification (IQ), Unit Testing or Operational Qualification (OQ), System Integration Testing (SIT), and User Acceptance Testing (UAT) or Performance Qualification (PQ), Configuration Records, Standard Operating Procedures (SOPs), Reports, Deviations and User Process Monitoring (UPM). Data Integrity Gap Assessments for Computerized Systems to meet 21 CFR Part 11 and Health Canada part 210/211, Electronic Records/Electronic Signatures, and ALCOA+ compliance.

Management: Over Twenty years managing processes conducted for qualification / validation procedures, process/SOP improvement and client/regulatory audit compliance, coaching/mentoring/development of personnel, interdepartmental / vendor relations and contract negotiations. Training of personnel during system implementations.

Technical: Expertise in specialization of IT application system administration for manufacturing operations in pharmaceutical environment at multiple sites and software application upgrade deployments.

CASE STUDIES

Project Experience

Projects that VSAM Knowledge Solutions Inc have worked on have consisted of:

1. Digital Adoption plans to leverage digital technologies to reduce manual processes, improve operational efficiency, enhance customer engagement and increase sales.  The digital adoption plan provides insight toward creating a technology plan that is directly linked to client’s business objectives. We provided clients with a roadmap and 3 solutions for 1 technology with the highest impact. The digital adoption plan was well-integrated with existing business landscape software systems that included ballpark costs. We prepared the customer for execution of a roadmap and adoption of new technologies.

2.IT Service Delivery Management that required IT application system administration of critical GXP IT Quality and IT Industrial Manufacturing business applications and management of resources driving tickets to meet SLAs and low ticket counts.

3. Business Analysis and Project Management of system upgrades or new system implementations using full software development lifecycle deliverables (SDLC).  The projects were in compliance to ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Plus = Complete, Consistent, Enduring and Available), Data Integrity, 21 CFR Part 11 and Health Canada part 210/211 compliance. These deliverables include Validation Plans (VPs), User Requirement Specifications (URS), Functional Specifications (FS), Hardware/Software Design Specifications (DS), Traceability Matrix (TM), Installation Qualification (IQ), Unit Testing or Operational Qualification (OQ), System Integration Testing (SIT), and User Acceptance Testing (UAT) or Performance Qualification (PQ), Configuration Records, Standard Operating Procedures (SOPs), Reports, Deviations and User Process Monitoring (UPM).

4. IT Project management services of industrial system applications and Electronic Resource Planning (SAP) applications expertise for pharma, vaccines, clinical, generics, and sterile manufacturing companies in Toronto, the GTA, and across Canada and the US. We have worked with large pharmaceutical companies. These deliverables included Project Charter, Project kick-off, Risk Workshop, Work Breakdown Structure (WBS), Capacity Planning, RAID (Risk, Action, Information, Decision) Log, Project change requests, Software Development Life Cycle Gate (SDLC) Deliverables, Sponsor and Stakeholder Project Meetings and Presentations, Lessons Learned.

5. Program Management services that require tracking, reporting, forecasting and resource management for organizational portfolios (ERP or IT Industrial Manufacturing).