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Computer System Validation

Mastering Compliance , Ensuring Integrity and Efficiency through Reliable CSV Solutions

We ensure that every detail is thoroughly verified and meets all requirements.

We validate by examination and provision of objective evidence that software parameters align with user needs and intended uses, and that specific requirements implemented through software can be consistently fulfilled.

At Zenovel, we uses the GAMP 5 “V-Model” to ensure the safety, accuracy, and quality of computerized systems used in GxP activities, including production, raw material receipt, storage, dispensing, exporting, and quality control. This risk-based methodology includes IT infrastructure verification, routine reviews, system shutdown, planning, specifications, setup, verification, and reporting.

  • Our Key Expert Services Involves

We are able to assist you in the following areas of services:

  • Computer Systems Validation for Manufacturing / Laboratory Instruments: It ensures the validation of instruments such as PLC, SCADA, BMS, MES,LIMS , ERP, EBMR-EBPR, DMS-LMS
  • CSV for Excel Validation and Clinical Research Software
  • Data Integrity Audit and GAP Analysis: Ensuring 21 CFR Part 11 and Annex 11 compliance, third party vendor audit, FAT- SAT for equipment
  • Remediation for CSV- DATA Integrity related issues.
  • Fool proof System owner validation tasks: Services like data integrity, backup – restoration, archival- retrieval data retention and migration check.
  • Compliance Training: Covering topics such as importance of validation, the role of FDA, 21 CFR part 11 compliance, Annex- 11, ALCOA+, GAMP5, risk assessment, CSV deliverables, data integrity, and insights from recent and historical 483- warning letters
  • Why Choose Zenovel ?
  • Cost Reduction and Time Efficiency
We utilizes appropriate CSV and CSA to ensure prompt compliance and reduce operating cost
  • Dedicated to Adherence

We apply audit trials and clear, unambiguous documentation to demonstrate compliance with Annex 11, and 21 CFR Part 11.

  • Assurance

Our procedure prioritizes data integrity, accuracy, dependability, and consistency, ensuring clients receive reliable and trustworthy results.

  • Flexible delivery model

We offer customized delivery options through the use of offshore, remote, and onsite resources.

Blogs and news

Our Latest Article

Nitrosamine Control

FDA’s Approach to Nitrosamine Control: Innovative Solutions for Drug Safety and Compliance

Understanding Nitrosamine Impurities in Pharmaceuticals: Nitrosamines, particularly N-nitrosamines, are probable or possible human carcinogens. They can form during the synthesis of active pharmaceutical ingredients (APIs) or during the storage of finished drug products. FDA guidance emphasizes the need for risk assessment, mitigation strategies, and regulatory compliance to control nitrosamine levels.

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Nitrosamine Control

In-Process Monitoring for BA/BE Studies: A Focus on DDIs

Introduction: In-process monitoring is a critical component of ensuring the quality and reliability of BA/BE studies, especially those involving drug-drug interactions (DDIs). For DDI studies, in-process monitoring is particularly crucial due to the complex nature of interactions, the need for precise data, and the potential impact on patient safety. Key

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Risk-Based Monitoring

Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)

Abstract For the past few years, regulatory bodies, industry advocacy groups, and private companies have been tackling the concept of incorporating risk into the design of clinical trials and customizing monitoring strategies based on those risks to achieve higher-quality outcomes. Regulatory guidance like ICH and FDA encourag sponsors to adopt

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Mastering Inhalation Studies

Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Introduction In the realm of inhalation studies, achieving consistent compliance and accurate results is a considerable challenge due to the complexities associated with trial conduct. Zenovel, a third-party monitoring company, boasts extensive experience in monitoring inhalation studies. This article sheds light on Zenovel’s recent involvement in the monitoring of three

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Data integrity

Ensuring Data Integrity: Best Practices and Considerations

Introduction There are multiple definitions of data integrity, yet the essence is the same. Data integrity is the overall accuracy, completeness, and consistency of data. Data integrity is the maintenance of, and the assurance of the accuracy and consistency of data over its entire life-cycle and is a critical aspect

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GCP Audit and Monitoring

Enhancing Clinical Studies with GCP Audit and Monitoring

Understanding GCP Audit and Monitoring GCP guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide a framework to ensure the ethical conduct, safety, and quality of clinical trials. Audit and monitoring are essential components of GCP compliance and play a

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We provide affordable, innovative, and high-quality solutions to pharma industry with ethics driven research and increasing accessibility to high quality medicine worldwide
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Contact Us

  • India
  • Australia
  • 9, Blaxland Avenue,
    Cranbourne North,
    Victoria-3977, Australia
  • Brazil 
  • Rua Praia do Tubarão, Quadra C,Loteamento Eco Vilas, Lote 13 – Vilas do Atlântico 42708-730 Lauro de Freitas, Bahia, Brazil
  • Brazil 
  • R. Álvaro Müler, 932 - Vila Angelino Rossi, Campinas-SP,13023-240, Sao Paulo, Brazil.
  • USA
  • 911 Hwy 6 Hitchcock,
    Texas, 77563, USA
  • Canada
  • 215 Moorlands Crescent,
    Kitchener, Ontario N2P 0C3
  • China
  • Zhenjiang Tech Park, Shanghai China
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