Quality in Core

  QUALITY TO THE CORE

Our Expertise

  • Spreadsheet Categorization and Assessment 

  • SSV Methodology, Best Practices, Tools & Templates

  • Statistical Sampling Plans for SSV Testing 

  • Creation, Execution & Implementation of Validation Protocols & Reports 

  • Implementation of Data Integrity Controls

  • Alternative Solutions to Spreadsheet Usage

  • Risk-based Prioritization of Remediation Projects 

  • ​Maintenance of Spreadsheet Validated Status (Standard Operating Procedures and Best Practices)

  • ​Spreadsheet Version Control and Change Management 

  • ​​Creation and Implementation of Training Materials (Key Concepts, Best Practices, Industry Trends, Implementation Requirements, Challenges, Potential Solutions and Case Studies)​

​​​We have a team of data integrity experts with over 20 years of experience working globally for various organizations such as Abbott Laboratories, AbbVie, Novartis, Edwards Lifesciences, Johnson & Johnson, Coviden, Endologix, PDL BioPharma, McNeil etc. With a wide array of knowledge and experience, our consultants bring the necessary expertise to tackle all types of data integrity issues. 


Our Expertise

  • Data Integrity Policy, Procedures & Requirements

  • Risk Based Approach for Analysis of Systems & Processes  

  • Prerequisite Checklists for Specific Areas 

  • Distinct Investigation Framework for Root Cause of Analysis​          ​          ​                                        (Laboratory & Manufacturing Areas)

  • Testing Procedures for Monitoring, Review & Verification

  • Best Practices for Electronic Records & Electronic Signatures (ERES) management 

  • ​Best Practices for Audit Trail Review 

  • Cost-efficient 21 CFR Part 11 & EU GMP Annex 11 Compliance Program

  • ERES Assessment & Remediation projects

  • 21 CFR Part 11 Inspection Readiness support

  • Generation, Execution, Review & Approval of Data Integrity related Protocols & Reports

  • Data Integrity Continuous Improvement Model (Best Practices for Paper and Electronic Records)

  • ​Data Integrity Compliance Training Program 

​​QIC uses an innovative approach to help clients meet the regulatory requirements and establish robust system validation lifecycle practices. Our experts provide support in creation, execution and approval of validation packages for all types of computerized systems - Management Information Systems, Computerized Systems used in Manufacturing Area, and Computerized Laboratory Systems.

Computer System Validation (CSV)

Our Expertise 

  • ​​Creation of GMP System Inventory

  • User Requirements and Process Mapping 

  • Computer System Validation Methodology, Best Practices, Tools & Templates

  • Application of Risk Management Best Practices to System Validation Lifecycle

  • Validation Planning, Documentation, Execution, Review & Approval Activities

  • System Testing (Unit & Integration Testing, User Acceptance Testing)

  • Risk-based Prioritization of Remediation Activities 

  • Continuous Improvement Best Practices to ensure Cost Efficiency & meet current Regulatory Expectations 

  • Periodic Review Best Practices 

  • ​Maintenance of System Validated Status (Standard Operating Procedures and Best Practices)

  • ​Validation Change Control and Change Management Process 

  • Creation and Implementation of Training Materials (Key Concepts, Best Practices, Industry Trends, Implementation Requirements, Challenges, Potential Solutions and Case Studies)​

As businesses are growing globally and are becoming more complex,  many organizations are increasingly relying on spreadsheets as a tool for data storage and analysis. Although easy-to-create and use, spreadsheets without adequate controls pose increased data integrity risk in GMP, GLP, and GCP environments. Here at QIC, we have a team of experts dedicated to help our clients with the following

  • Spreadsheet Verification and Validation needs

  • Implementation of data integrity controls that ensure compliance to 21 CFR Part 11 & EU Annex 11

  • Identification of alternative solutions for long term usage of spreadsheets 

Data Integrity Assurance (DIA)

Spreadsheet Verification and Validation (SSV)

We are your One Stop Shop for Validation. Besides our technical expertise, we offer clients following support services that allow us to provide you a holistic, competitive and cost-efficient solution.


  • Site Audit Support 

​​            Whether you need assistance with Quality Systems, Data Integrity, Risk Management or Vendor Assessments, we're ready to partner with you to support patient safety through our audit compliance program and lifecycle support. Our experts have decades of experience in compliance auditing and can help you prepare for inspections and mock audits. 


  • Project Management Support 

            Planning and budgeting are essentials for the success of any project. Without a well-planned budget, key objectives and timeline, projects can fall apart and be delayed or left incomplete. To ensure successful allocation of resources and timely execution of project activities, we offer business-enhancing agile PMO services. Our team of Certified Project Managers, Program Managers, Project Schedulers and Project Coordinators offer a full spectrum of project management services from planning and coordinating activities to execution and completion of work.  Regardless of the scale or complexity of the project, we employ and refine our processed to provide robust control, governance and transparency from inception to completion. At the point of every decision we make on behalf of our clients, we challenge the status quo and work diligently to find the smartest, most efficient and most cost-effective solution. 


  • Translation & Language Services 

            We speak your local language and provide translation services to ensure harmonized compliance. Our translators have experience in various discipline so they are familiar with the technical terms and concepts specific to the subject matter. Our translated work is validated through back translations and the translated content is verified by more than one expert linguist, so you can rely on its technical accuracy. 


  • Global Training Program 

      One of the commonly seen issue in industry is related to harmonization and standardization of knowledge, key concepts and best practices. We have trained professionals that blend together their scientific and business-process knowledge, along with world-class instructional design techniques to deliver a holistic training program per client's needs. Our training and communication solutions range from live instructor-led training and eLearning to technical writing and knowledge base development. 

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  • Center of Excellence (CoE)​

​​           Our mission is to provide total lifecycle support to our clients and one of the ways we do this is by providing  ​24x7 free access to our Center of Excellence. Our experts at CoE provide continuous improvement solutions and keep our clients abreast of the changing regulatory landscape. We also offer Helpline Sessions and Forums to discuss best practices, share expertise on industry hot topics and provide technical kno-hows on existing problems. Post-completion of the contract, our clients continue to have access to our CoE as well as our virtual library. 


  • Placement Services 

​​           We are committed to connecting great companies with great employees and opening up opportunities for both by providing the highest quality of outsourced employment and human resource services. Success for our customers is reached by empowering them to focus on what they do best. We help our clients to achieve sustained compliance via recruitment of trained professionals and subject matter experts. We facilitate the hiring process by understanding your need, identifying appropriate talent and coordinating interview process, as required. 

Support Services