Data Integrity Assurance

Data Integrity is of paramount importance in the healthcare and pharmaceutical industry. Our team at QiC with 20 years of experience, bring in the necessary expertise to tackle all types of data integrity issues and ensure accurate and validated data. We deal with Data Integrity Compliance for US, FDA, EU, Health Canada, ICH, ISO, TGA and other regulatory bodies.

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Conforming to GxP Compliance, every computer system must have documented evidence that the system does what it is intended, and that users of the system can detect when the system is not performing as intended. Our professionals at QiC apply an innovative approach for validation and help customers meet the regulatory requirements using the best practices.

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Computer System Validation

Spreadsheet Verification & Validation

Spreadsheets are widely used for storing and analysis of data in a structured way. To protect the data integrity of spreadsheets conforming to GxP compliance, our professionals at QiC expertise in spreadsheet verification and validation needs.

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QiC team helps in validation process, quality systems procedures and data management for Manufacturing & Laboratory Services.

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Manufacturing & Laboratory Support Services

GxP Compliance & Remediation Support

QiC’s professionals help our partners to develop, implement and maintain effective compliance programs which facilitate in meeting their business objectives.

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QiC experts specialize in cGMP requirements and are globally renowned in providing expertise in the creation, implementation and maintenance of cGMP compliance. To ensure compliance, our experts work with clients to implement an effective quality management system that aligns with clients’ cGMP vision.

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Quality Management System

Due Diligence Audit

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

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We have a team of skilled technical writers for developing customized content as per your business need.

Our technical writers work with a clear focused approach and develop clear, concise and structured content after thorough analysis of the end user requirements.

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Technical Writing

Project Management Support

A well-planned schedule, key objectives, timeline, deliverables, quality and communication are some of the key parameters on which the success of a project depends. To ensure successful allocation of resources and timely execution of project activities, we offer business-enhancing agile PMO services.

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Our training programs are designed by experienced Instructional Designers who design the training program with measurable leaning objectives. All the Validation and Compliance training focuses on Key Concepts, Best Practices, Industry Trends, Implementation Requirements, Challenges, Potential Solutions and Case Studies.

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Global Training Program Support

Automation Engineering Support

Our experts have experience in providing automation solution for your manufacturing process. We understand the requirement and propose the automation solution based on the requirements of the process.

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Digital technology is revolutionizing our industries. Artificial intelligence (AI), Robotics and the Internet of Things (IoT) are transforming the future of business at all levels.

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Digital Governance

Systems Evaluation

QiC partners with clients to provide world-class evaluations of their R&D systems,manufacturing systems and processes, and quality control/assurance systems. Our experts are globally recognized to evaluate and make effective recommendations for enhancing current systems and processes.

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QiC experts are skilled in providing facility design support and facility related compliance support.

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Facilities Design or Validation

Quality Assurance And Support

Quality in Core is particularly skilled in assessing and enhancing quality assurance and controls—from the way technical issues are handled to the organizational structure of quality units.

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For further inquiry, please CONTACT US.