GMP CSV services
Mastering Compliance , Ensuring Integrity and Efficiency through Reliable CSV Solutions
We ensure that every detail is thoroughly verified and meets all requirements with our Computer System Validation Services
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 for GMP CSV Services?
- Cost Reduction and Time Efficiency
- 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
In the pharmaceutical and biotechnology industries, obtaining regulatory approval is essential prior to introducing new drugs or biologics to the market. A pivotal aspect of this approval process is the FDA Pre-Approval Inspection (PAI), which involves a comprehensive assessment of manufacturing facilities, processes, and data integrity to ensure adherence to
Risk-Based Monitoring (RBM) is a more efficient alternative to traditional clinical trials, focusing on high-risk areas through data-driven insights. It ensures patient safety, data integrity, and regulatory compliance while reducing costs and timelines. However, the success of RBM depends on the competency of monitors, who identify risks, analyze data, and
Welcome to the Zenovel Blog! We are a leading provider of drug regulatory consulting and education, focusing on advancing pharmaceutical innovation while ensuring safety and compliance. This blog delves into the essentials of Drug Regulatory Affairs (DRA), covering its scope, career opportunities, and intricate processes involved in bringing new drugs
The international pharmaceutical landscape is inherently connected to the global economy and global trade, which is consisted with the quality and safety assurance , well-controlled quality and safety. Compliance with international pharmaceutical standards has changed from an optional step to a requirement. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is the
Lipinski’s Rule of 5 (Ro5) is a crucial guideline in pharmaceutical development, helping researchers evaluate a compound’s likelihood of becoming an effective oral drug. However, with the rapid evolution of therapeutic strategies, it’s worth considering the relevance of Ro5 in the current drug design landscape. Understanding Lipinski’s Rule of 5
Regulatory affairs (RA) play a crucial role in the pharmaceutical industry; ensuring products meet quality, safety, and efficacy. As the industry grow further the need for qualified professionals to bridge gaps between companies and regulators increases. This blog explores Zenovel regulatory affairs expertise, our various facets, and valuable contribution to
