Our Services

QiC partners with clients to work on the following steps for the conceptualization and implementation of a QMS :

• Define and Map Your Processes
• Define Robust Quality Policy
• Define Robust QMS Objectives
• Develop Metrics to Track and Monitor CSF Data
• Define Defects for Every Process
• Develop Documents and Records
• Define Quality Process
• Determine Training Needs
• Use Quality Management System
• Measure, Monitor and Implement Activities to Improve Performance
• Conduct Training to Ensure Standardization and Consistency

In this journey of digital transformation, QiC partners with its clients to

• provide its expertise in “Digital Governance = Integrating New Technologies for Better Business”
• ensure seamless transition into the next business generation
• deliver an intelligent and compelling experience of digital transformation

For each customer, we identify an optimal digital transformation path and establish the digital governance strategy based on:

• Business Needs
• Market trends and Innovation
• In-house quantitative and qualitative analysis
• Regulatory and technical compliance requirements
• Availability of digital tools and techniques

QiC digital governance approach involves 4 stages of consulting in order to ensure a holistic digital transformation experience.

Stage I : Discovery Phase

During this stage, we initiate the process of digital transformation with a Business Overview to review needs and objectives. We conduct additional assessment to help create the strategy hypothesis leading to the next stage.

Stage II : Planning Phase

During the planning stage, we review the value hypothesis, and leverage a feedback mechanism to reach a final strategic decision. In this process, we conduct detailed calculations and provide our estimation for implementation costs and project benefits; furthermore we create ROI & TCO models that demonstrate the quantified solution.

Stage III : Implementation Phase

During the implementation stage, we use our vast expertise to establish the framework and execution steps for implementation of identified solution(s) that are cost-efficient and that
align with business goals. For each solution, we define objectives, priorities, deliverables and implementation control points. We execute each step and ensure creation of high quality deliverables. Upon completion, a quantitative and qualitative analysis is performed to validate the completion of project.

Stage IV : Continued Excellence

Upon completion of implementation, we strive to ensure continued excellence by establishing and tracking key performance indicators (KPIs). Based on project KPIs, we strive to improve and adjust where needed, in order to align with the established business strategy and to keep up with advancements in digital world.

QiC Digital Governance Journey focuses on five different domains in order to ensure success of business.

• Cyber Security
• System Lifecycle
• IT Infrastructure
• IT Governance
• Digital Enablers

Please contact us for further information on these domains and our specific approach on reducing the risks associated with each domain.

QiC experts in R&D and manufacturing systems assessments routinely assist clients in:

• Implementing quality by design for successful commercialization
• Analyzing and managing risk in the R&D and manufacturing environments
• Developing requirements and performing audits for clinical material GMP (Phases I, II, and III)
• Assessing and streamlining development practices

In the realm of quality control and quality assurance systems, QiC’s consultants are the “go-to” people when needs include:

• Assessing and managing risk vis-à-vis quality systems
• Evaluating and enhancing quality unit roles and responsibilities
• Assessing and improving facilities and equipment systems, materials systems, production systems, and laboratory controls systems

We leverage are compliance, regulatory, scientific, and technical expertise to provide assistance in:

• Analyzing, developing, and/or enhancing engineering requirements, specifications, and drawings, including HVAC, water, sterilization, and dust-control systems
• Developing environmental and processing-room requirements
• Recommending effective flow of materials, equipment, and personnel
• Assessing and enhancing facilities requirements vis-à-vis manufacturing, assembly, packaging/labeling, and distribution operations
• Addressing the facilities requirements of laboratory operations
• Performing factory acceptance testing of equipment (FAT)
• Conducting audits during construction and installation phases
• Qualifying facilities for sterile, low-bioburden, and non-sterile products
• Qualifying facilities for intermediates, APIs, and finished drug products
• Qualifying facilities for medical device components and finished products

• Evaluating written procedures and standard operating procedures
• Helping to interpret regulations in concert with industry standards
• Developing laboratory quality, analytical methods, methods validations, and product component specifications
• Creating a program to meet current FDA expectations for GCP Compliance
• Consulting self-evaluations
• Building sampling plans
• Performing trend analysis
• Providing corporate oversight programs and enhancement—including good governance practices; corporate quality/compliance functions and oversight practices; and independent advice to CEOs, senior managers, and board members
• Implementing site oversight programs, including internal audits and performance metrics
• Reviewing and enhancing management controls
• Reviewing and enhancing organizational structures—including functions, reporting relationships, responsibilities, staffing and competence; communication systems and performance (vertical and horizontal); and independence, staffing, and competence of quality units