VSAM Knowledge Solutions Inc
Taking Technology Solutions to Another Level
Specializing in pharma, vaccines, clinical, generics, and sterile manufacturing, VSAM Knowledge Solutions Inc brings over 20 years of experience to IT consulting and contract services in Digital Consulting for digital adoption of digitized tools for your organization, Computerized System Validation, Project and Program management and Business Analysis in system deployment solutions. Based in Toronto, we provide technology solutions for clients across Canada and the US.
Our services include
- 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 provide clients with a roadmap and 3 solutions for 1 technology with the highest impact. The digital adoption plan is well-integrated with existing business landscape software systems that include ballpark costs. We prepare the customer for execution of a roadmap and adoption of new technologies.
- We provide EMR software selections and implement them by providing project management and business analyst services. 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 identified below, Sponsor and Stakeholder Project Meetings and Presentations, Lessons Learned. We provide business analysis services that include deliverables like User Requirement Specifications (URS); Functional Specifications (FS), Gap Analysis, Process Mapping and Workflow Diagrams, Vendor Evaluation and Selection, System Design and Prototyping, User Acceptance Testing (UAT) and Reports, Training Materials and User Guides with Training, Change Management Plan, Project Status Reports and a Post-Implementation Review.
- Program management and service delivery management support that provided tracking, forecasting, and resource management for ERP and Toronto IT Industrial Manufacturing Portfolio projects.
- IT Project management services of industrial system applications and Electronic Resource Planning (SAP) applications expertise for pharma, vaccines, clinical, generics, branded and sterile manufacturing companies in Toronto, the GTA, and across Canada and the US. We have worked with large pharmaceutical companies for Computerized Systems deployments which include waterfall or hybrid or agile project management methodology. 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.
- Business Analysis and Project Management of full software development lifecycle deliverables (SDLC) that 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); business process mapping models, topology diagrams, and charts to provide directions to developers; 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 and Standard Operating Procedures (SOPs).
- Service delivery that required IT application system administration of critical GXP IT Quality and IT Industrial Manufacturing business applications. The support of manufacturing operations also required Audit support for these administrated systems from Regulatory Bodies such as the FDA and Health Canada.
Program Project Management
Expertise in strategic ideation, discovery, initiation, planning, design, development, execution and management of computerized equipment/software validation projects.
Management
Over Twenty years managing processes conducted for qualification / validation procedures, process/SOP improvement and client/regulatory audit..
Technical
Expertise in specialization of IT application system administration for manufacturing operations in pharmaceutical environment at multiple sites.
Leadership
Founded by Vishal Magoon, PEng, PMP, our team brings a wealth of expertise in engineering and project management. Certified in various methodologies including Agile, our leadership ensures efficient and effective project delivery tailored to your needs.
Purpose
At VSAM, we envision a society where people enjoy better living standards and improved quality of life. By deploying compliant computerized systems, we address personal health challenges, providing patients with the care they need. As trusted partners, we offer integrity, professionalism, and collaboration to support industry leaders in overcoming technology and supply chain challenges.
Contact Us
For more information on our IT consulting, contract services, and how we can support your Health Care and Pharma projects, reach out to us today. Together, we can drive technology solutions that benefit patients and elevate your business.
Connecting People for Over 20 Years
20
Professional Engineer (PENG), Project Management Professional (PMP), Certified Scrum Master (CSM), and PMI- Agile Certified Practitioner (PMI-ACP)
As an engineering graduate of Ryerson University, founder Vishal Magoon, PEng, PMP has continued to progress for more than two decades. As a Professional Engineer (PENG) , Project Management Professional (PMP)® , Certified Scrum Master (CSM) and PMI-Agile Certified Practitioner (PMI-ACP), Vishal is certified to have the project leadership and engineering skills you seek to gain a competitive edge and work smarter. He is experienced with waterfall, hybrid and agile methodologies. With extensive North American experience, you can trust Vishal and VSAM Knowledge Solutions to provide consulting services that optimize your business environment, processes, and people.
Specializing in Pharma, Vaccines, Clinical, Branded, Generics, and Sterile Manufacturing
Recent projects of VSAM Knowledge Solutions have included:
1. Digital Adoption Plans:
CASE STUDY
Situation_ VSAM Knowledge Solutions provided a digital adoption plan for a small business travel agency to leverage digital technologies to improve operational efficiency, enhance customer engagement and increase sales.
Obstacle__ The scope was to provide the travel agency with planning methodologies and insight toward creating a technology plan that directly linked to their business objectives. The goal was to provide the client with a roadmap and 3 solutions for 1 technology with the highest impact. The digital adoption plan was to be well-integrated with existing systems that included ballpark costs. The goal was to prepare the customer for execution of a roadmap and adoption of new technologies.
Actions __A kickoff was conducted to present the objectives, review the timeline and approach, discuss the winning condition and book the workshops. The project was broken down into 3 phases: Discovery, Develop and Deliver.
The 1st phase consisted of workshops a) Business Objectives Workshop in which a Business Strategy Alignment workshop in which the business model canvas (BMC), business objectives and quote/order to cash process was reviewed; b) Digital Impact Workshop in which a Digital Maturity Assessment was reviewed and compared to other similar sectors, educating the client of digital intensity and digital culture, exploring the impact of digital on your organization with key action items with RACI relative to intensity and culture ; c) Customer Experience Workshop in which the customer experience and technology stack was documented and review to support each touch point in the customers experience, and to educate the client how the customer’s sales funnel might integrate to the back office.
The 2nd phase consisted of a a) Digital Strategy Alignment workshop in which priorities were established and aligned; review of the outcome from phase 1 workshops; clarification of the most priority technology for research; focusing and confirming the expectation with the client on researching 3 options of 1 technology; b) Securing your Business Workshop in which a review of the risks and impact of cybercrime and defining top actions to protect the business was performed using a Cybersecurity Assessment; and exploring the importance of managing customer data and securing information with backups.
The 3rd phase consisted of a) Performing solutions research where 3 viable solutions based on single, most impactful technology y (1 type vs. stack), evaluating financial fit, business fit (technical support, benefits), skill requirements, and integrations b) Representation of Phase 1 and Phase 2 c) Introduction to the solution research, recommendations and digital roadmap. d) Insights on project management, culture and governance centered on digital adoption.
Results_The digital adoption plan for the small business travel agency provided a review of 3 software developers for integrating the Travel CRM along with business landscape APIs with a Self-service web portal. The 3 business objectives were reviewed and the resulting implementation roadmap. The cybersecurity assessment was reviewed and the impact of implementing changes to the small business from the original score of the current cybersecurity of the organization. The improvement to the quote to cash with the implementation of the digital technology. Project was delivered on time and on budget.
2. Health Care:
CASE STUDY
Situation_ Canadian Addiction Treatment Center needed to determine the best EMR (Electronic Medical Record) software for 3 sites
Obstacle__ The scope was to act as a project manager and business analyst to coordinate sponsors, stakeholders, ITS, Quality and business system owners for the determination of the best EMR software that would fit the Canadian Addiction Treatment Center objective of having a self-service onsite patient intake solution
Actions __As a project manager provided a project plan and coordinated sponsor, stakeholders, ITS, Quality and business system owners to gather input on requirements for self-service onsite patient intake solution. Gathered input on weighting of requirements from ITS, Quality and business system owner sand feedback from physicians. Reviewed 3 solutions Juno, Accuro and PatientVu on features and how best it was aligned with the requirements creating a weighted matrix. Created subjective ranking of each feature alignment (L, M, H) to the requirements and analyzed the results within the weighted matrix of the 3 solutions.
Results_ The EMR solutions selected was PatientVu and was presented to the sponsors and stakeholders as a presentation showing the results of the analysis of the weighted matrix and the final EMR Software selection. Project was delivered on time and on budget.
3. Program management:
CASE STUDY
Situation_ VSAM Knowledge Solutions provided a resource that fulfilled the role as Program Director for ITS managed services of ERP and Toronto IT Industrial Manufacturing Portfolio projects at Sanofi Pasteur Toronto.
Obstacle__ The scope was to provide service delivery and service management of the program that had 13+ resources on project components aligned with Sanofi’s strategic portfolio within the ERP and Toronto IT Industrial Manufacturing. The program manager was to ensure onboarding/offboarding, resource planning/forecasting and overall status of the program.
Actions __Using software “Monday.com”, the program manager was tracking, reporting, forecasting, and managed resource capacity of the program. The program manager worked with the PM/BAs/Developer contractors to conduct standup meetings weekly, 1 to 1 meetings weekly and ensured resources would recording actual hours for budget project components and project status updates (accomplishments, in-progress/next-steps and risks/roadblocks). The program manager provided onboarding/offboarding of resources to the client and the Program and expectations. The program manager provided insight to sponsors for resource allocation/capacity/skill set to new intake of project components.
Results_ The program manager was able to provide a detailed resource monitoring/allocation/forecasting through the program management tool “Monday.com” and delivered to the sponsors overall program health status updates and roadblock mitigation requirements on a monthly basis.
4. IT Project management services:
CASE STUDY
Situation_ VSAM Knowledge Solutions supplied a Project Manager (PM) resource for the ITS department at a client and was assigned an upgrade project for an mBPR EDMS system at a client. It was identified to the PM that the project was in trouble and the previous PM was leaving.
Obstacle__ The scope was to provide project management for a complex mBPR EDMS software upgrade that consisted of a project team of 12 to 14 resources and senior functional area sponsors within a budget of $750K.
Actions __The PM reviewed the Dev environment against the URS, FS and DS. It was determined that the system documentation and installation procedure did not match the DEV environment and the VAL environment was created from scratch. It was complex project which entailed upgrade from SQL 2003 to SQL 2008 then data migration to SQL 2008 followed by an upgrade to SQL 2012 DB. The PM delivered IT PMO deliverables through gate reviews (Project Charter, Project kick-off, Risk Workshop, WBS, Capacity Planning, RAID Log and Project change requests). The PM provided monthly sponsor updates and identified and proposed mitigation of risks. The PM provided updates to finance obtaining data from SAP for vendor forecasts and to assist in carryover as well as Capex budgeting.
Results_ The PM was able to successfully delivery the project with some of the risks triggered and mitigated.
5. IT Service delivery management that required IT application system administration:
CASE STUDY
Situation_ VSAM Knowledge Solutions provided a resource that fulfilled the role as Program Director for ITS managed services of ERP and Toronto IT Industrial Manufacturing Portfolio projects at a client site. The same resource was assigned IT administration of certain GXP applications in the Industrial Manufacturing Portfolio.
Obstacle__ The scope was to provide service management of the program that had 13+ resources on project components aligned with Sanofi’s strategic portfolio within the ERP and Toronto IT Industrial Manufacturing.
Actions __Using ServiceNow software, the Program Director worked with the BAs/Developer contractors to conduct standup meetings weekly, 1 to 1 meetings weekly updates which had them record accomplishments, in-progress/next-steps and risks/roadblocks. The ticket count was evaluated for each Service Now queue to identify tickets that were open, in-progress and resolved. As the risks/roadblocks were reviewed in the 1 to 1 meetings, they were understood to identify how the risks/roadblocks could be mitigated and then escalated to the sponsors for support.
Results_ The Program Director was able to provide a detailed list of reports of tickets through ServiceNow and delivered to the sponsors the overall health status check of the Industrial Manufacturing portfolio updates and roadblock mitigation requirements on a monthly basis. Ticket counts were scaled down to less than 10 tickets that were unresolved on average.
6. Business Analysis and Project Management:
CASE STUDY
Situation_ VSAM Knowledge Solutions provided a PM/Business Analysis resource that led projects and programs for a client site at 3 sites in particular there was a Data Integrity gap assessment and remediation project that identified 60 equipment to be assessed for gaps and mitigated for risks.
Obstacle__ The scope was to provide a data integrity gap assessment, remediation/mitigation of risks plan for the identified 60 pieces of equipment and implement the changes for compliance or mitigate risks to data integrity within a $575K budget.
Actions __Worked with the PM contractors to conduct a 3 phase approach. The 1st phase was a preliminary assessment of equipment that had risks to Data Integrity. The 2nd phase was to identify the data integrity gaps and the compliance to category under 21 CFR Part 11 and Part 210 and 211 regulations. The 3rd phase was to establish a remediation plan with timelines that update of SOPs and/or validation documentation that included VPs, URS, FS, Hardware/Software DS, TM, IQ, Unit Testing or OQ, SIT, and UAT or PQ, Configuration Records, Reports, Deviations and User Process Monitoring (UPM). Regular project status updates were provided through Clarity software to the IT PMO and project sponsor updates. IT PMO deliverables were provided through gate reviews (Project Charter, Project kick-off, Risk Workshop, WBS, Capacity Planning, Risk Log and Project change requests). Updates were provided to finance obtaining data from Oracle and vendor forecasts and to assist in carryover as well as Capex budgeting.
Results_ Gap Analysis documentation was established and SOPs were updated and all 60 pieces of equipment were successfully mitigated for data integrity risk on time and on budget.
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.
We provide consulting services for Digital Adoption, program management and project management 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.
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Project Management Professionals 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:
IT Application System Administration
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.
IT Application System Administration
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Senior Business Analyst
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.
Senior Business Analyst
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Validation Engineer
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Validation Engineer
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Program/Project Manager
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.
Program/Project Manager
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Senior Validation Specialist
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Senior Validation Specialist
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Principal Consultant
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Principal Consultant
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