#Computer System Validation

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Ensure GMP compliance in your Indore pharmaceutical operations with Zenovel's expert Computer System Validation (CSV) services. We help you validate your critical systems for data integrity and regulatory adherence.

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Computer System Validation | Pharma Connections

Boost your expertise with our Online Computer System Validation Training Courses! Designed for both beginners and experienced professionals, our course includes assessments and certification to enhance your skills in CSV for the pharmaceutical industry. Enroll now and advance your career in compliance and validation!

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Indivirtus Healthcare Services

As a Contract Research Organization (CRO), Indivirtus Healthcare Services offers a wide range of services within the pharmaceutical and healthcare sectors. Initially, the company specialized in delivering Toxicological Risk Assessment Reports to pharmaceutical manufacturers. However, over time, it has expanded its service offerings to include numerous other services.

Established in 2018, Indivirtus Healthcare Services began its journey in a modest single-room office, staffed by just two individuals, led by Dr. Upendra Jain and Ms. Veena Kumari. Over the span of six years, this humble organization has evolved into a group of five companies, boasting seven offices worldwide and a workforce of over 100 employees. Indivirtus Healthcare Services has successfully served more than 500 clients across over 45 countries.

The range of services provided by Indivirtus Healthcare Services includes:

Toxicology:

Toxicology is the scientific field that involves the study of the harmful effects of chemicals on living organisms.

Cleaning Validation: This service ensures cleanliness to prevent contamination during production processes. It is achieved by calculating MACO (maximum allowable carryover) values based on health-based exposure limits such as PDE (Permitted Daily Exposure), ADE (Allowed Daily Exposure), and OEL (Occupational Exposure Limit), all established through thorough risk assessments. These reports adhere to guidelines set by EMA, ICH, APIC, AND PICS.

Genotoxic Evaluations of Impurities: Utilizing ICH M7 guidelines, this service assesses the genotoxicity and mutagenicity of impurities to determine their acceptability in drug substances and products.

Material Safety Data Sheets (MSDS): These provide detailed information on the safety and handling of materials.

GRAS Reports: These confirm the safety of substances for their intended use.

Regulatory Affairs/Regulatory Affairs (RA/Reg Affairs)

Preparation and Submission of CTD, ACTD & e-CTD Dossiers

Dossiers for Regulated, Semi-regulated, and WHO Regulated Market

CEP Filing & Submission on the EDQM Portal and DMF Filing to the FDA

Clinical & Non-Clinical Overviews and Summaries

Batch Releasing & Testing Site Service for Europe (BRS & BTS)

MAH & Local Agent Service for Europe & US

Pharmacovigilance and Drug Safety Services

PSMF Management

Single Case and Adverse Event Reporting

Aggregate Report Generation

Safety Physicians Support

Signal Management & Safety Surveillance

Literature Monitoring (Global and Local)

Medical Writing

Risk Management Plans (RMPs)

Electronic Submission Management

Medical Information Call Centre (MICC)

Qualified Person for Pharmacovigilance (QPPV) Support

Regulatory Authority Requests and Audit/Inspection Readiness

Social Media Monitoring for Adverse Events

Calibration Services

Indivirtus Healthcare Services is equipped to provide a variety of calibration services through a facility accredited by NABL (National Accreditation Board for Testing and Calibration Laboratories) (ISO/IEC: 17025:2017). Our calibration services cover a broad spectrum, including:

Calibration Facility in various dimensions, pressure, mass, volume, RPM, sound, electro-technical, and thermal.

Temperature Mapping and Validation Facility for Furnace, Chambers, Oven, and Cold Storage.

On-site Facility for Calibration.

Training on Quality Systems & Implementation.

Computerized System Validation (CSV)

Indivirtus Healthcare Services is dedicated to providing comprehensive services in CSV to ensure that systems are performing their intended tasks effectively. Our CSV services include:

Implementation and Validation of Computerized Systems.

Decommissioning of Computerized Systems.

Cloud Systems Validation.

Quality Systems for IT Departments and IT Service Suppliers.

Quality Systems for Software Validation.

Computer Infrastructure Qualification.

Audits for IT Solution Suppliers.

Training.

Clinical Research & Equivalence Studies

Indivirtus Healthcare Services provides a range of clinical research services, including feasibility assessments, participation in regulatory discussions, project oversight, management of clinical sites, handling of data and statistical analysis, and the conduct of Phase I, II, III clinical studies.

Technology Transfer (Tech Transfer)

Indivirtus Healthcare Services specializes in technology transfer services, facilitating the transition of drug substance production processes from research laboratories to commercial facilities. Our services include CMO (Commercial Manufacturing) site transfers and CMDO (Research and Development to Commercialization) services. We handle various aspects of technology transfer, such as:

Site transfers

Research and Development/Funding and Development

Dossiers/Know-how

Good Manufacturing Practices (GxP) and Auditing Services

Indivirtus Healthcare Services offers a variety of audit services to help identify and address deficiencies in processes, ensuring compliance. Our audit services include:

Internal audits and Good, Environment, Management, and Business Analysis (GEMBA) sessions

Third-party audits and Gap assessments

Pre-inspection and Due Diligence audits

Additional Services Provided by Indivirtus Healthcare Services include:

CMO/CDMO Facilities for the Sourcing of Formulations and Active Pharmaceutical Ingredients (APIs)

Greenfield/Brownfield Development Projects

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Managing Clinical Trial Data With Computer System Validation CSV

Managing Clinical Trial Data with Computer System Validation (CSV)

In the realm of clinical trials, ensuring the integrity, accuracy, and compliance of data is paramount. This is where Computer System Validation (CSV) comes into play, offering robust solutions to manage clinical trial master data effectively. CSV not only guarantees data accuracy and security but also ensures adherence to regulatory standards, optimizing the entire clinical trial process.

Understanding Computer System Validation (CSV)

Computer System Validation (CSV) is a documented process that helps ensure that both new and existing computer systems are fit for their intended use and operate in a reliable and consistent manner. For clinical trials, this means that the systems used to capture, process, and store data meet stringent regulatory requirements.

The Importance of CSV in Clinical Trials

Data Integrity: CSV ensures that the data collected and processed during clinical trials is accurate and reliable. This is crucial for making informed decisions about the safety and efficacy of new treatments.

Regulatory Compliance: Clinical trials are subject to strict regulations from bodies like the FDA and EMA. CSV ensures that all data handling systems comply with these regulations, reducing the risk of non-compliance and the associated penalties.

Data Security: Protecting sensitive patient data is a top priority in clinical trials. CSV includes measures to safeguard this data from unauthorized access, ensuring confidentiality and integrity.

Key Components of CSV in Clinical Trial Data Management

Validation Planning: This involves creating a detailed plan outlining the validation process, including objectives, scope, and responsibilities. A well-structured plan is the foundation of successful CSV implementation.

Requirement Specifications: Defining user and functional requirements is critical. These specifications serve as a benchmark to ensure that the system meets all necessary criteria.

Risk Assessment: Identifying and assessing risks associated with the system helps in prioritizing validation activities and implementing appropriate controls to mitigate these risks.

Testing and Documentation: Thorough testing is conducted to verify that the system functions as intended. All tests and results are meticulously documented to provide evidence of compliance.

Ongoing Monitoring and Maintenance: CSV is not a one-time activity. Continuous monitoring and periodic re-validation are essential to ensure that the system remains compliant and performs optimally over time.

Benefits of CSV in Clinical Trial Data Management

Enhanced Data Quality: With CSV, data is consistently accurate and reliable, which is crucial for the validity of clinical trial results.

Improved Efficiency: Automated systems validated through CSV streamline data management processes, reducing manual errors and saving time.

Regulatory Readiness: Systems that undergo CSV are always prepared for regulatory audits, ensuring smooth and compliant operations.

Increased Confidence: Stakeholders, including regulatory bodies, sponsors, and patients, have greater confidence in the trial outcomes when data is managed through validated systems.

Implementing CSV for Successful Clinical Trials

To successfully implement CSV in clinical trials, organizations should:

Develop a Comprehensive CSV Strategy: This should include a clear plan, defined roles and responsibilities, and a focus on continuous improvement.

Invest in Training and Resources: Ensure that all team members involved in the validation process are well-trained and have access to the necessary resources.

Leverage Technology: Utilize advanced validation tools and software to streamline the CSV process and enhance accuracy.

Engage with Experts: Collaborate with CSV experts to ensure that all aspects of the validation process are thoroughly addressed.

By embracing Computer System Validation, clinical trial organizations can ensure the integrity, security, and compliance of their data, ultimately supporting the success of their trials and the advancement of medical research.

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Precision Computer System Validation Consultants

Precision Computer System Validation Consultants are the architects of digital reliability, meticulously crafting systems that stand as beacons of accuracy and compliance in the digital realm. Masters of meticulous scrutiny, they navigate the intricate pathways of software and hardware integration, ensuring each component aligns seamlessly to uphold the highest standards of precision. With an arsenal of advanced tools and methodologies at their disposal, they meticulously assess, test, and refine systems, leaving no margin for error. These consultants are the guardians of data integrity, meticulously validating every line of code and every connection to guarantee flawless performance and compliance with regulatory standards. Their expertise serves as the cornerstone of digital trust, ensuring that systems not only function flawlessly but also inspire confidence in their reliability and precision.

[jsapharmaguideline]

SOPs Premium Template Download for Free

Welcome to JSA Pharma Guideline, your trusted source for All Department (QA/QC/MICRO/ENGG/HR/EHS/MFG) SOPs of Pharmaceutical and Medical Companies. Our SOPs Ready to implement with all annexures/Attachments included. Subscribe and download for free. For more info, visit our website: https://www.jsapharmaguideline.com/

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Computer System Validation in Pharma: Empowering Pharma Excellence and Unveiling Innovations in 2023

In the world of pharmaceuticals, precision and compliance are paramount. Involving every aspect of the process, from research and development to manufacturing and distribution, demands meticulous attention to detail.

Computer System Validation in Pharma (CSV), a linchpin in ensuring the seamless integration of technology while upholding regulatory standards.

READ MORE

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The CSV Training is Crucial to be Availed of

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Types of computer system

From personal computers to supercomputers, we shall examine several types of computer systems in this article. Try to comprehend their special qualities, uses, and contributions to various industries. Learn about the diversity and advances in computer technology that influence our contemporary world.

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Theory with no coherent proof on my part: brenner only visibly ages rapidly when a portal is open.

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Becoming a Certified Pharmacovigilance Professional: Importance of Computer System Validation for Professionals

In today’s rapidly evolving pharmaceutical and healthcare industries, the role of professionals who ensure the safety and efficacy of medicinal products is more critical than ever. The demand for qualified experts in pharmacovigilance (PV) is growing steadily, and one key aspect that enhances the expertise of these professionals is obtaining certification as a Pharmacovigilance Professional. Additionally, understanding the importance of Computer System Validation (CSV) has become a crucial part of their skill set, ensuring that systems used in the collection and processing of pharmacovigilance data are compliant, reliable, and efficient.

Understanding Pharmacovigilance and Its Importance

Pharmacovigilance refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Pharmacovigilance professionals play a significant role in ensuring that the public health remains protected while maintaining a robust regulatory framework for medicines. They are responsible for collecting data from clinical trials, post-marketing surveillance, and spontaneous reporting, then analyzing this information to identify potential safety concerns or trends.

With the rise of complex global healthcare systems and the increasing use of medications, the importance of pharmacovigilance cannot be overstated. Professionals working in this field must be well-versed in regulatory guidelines, adverse event reporting procedures, risk management strategies, and safety assessments to protect public health.

The Role of Certification in Pharmacovigilance

Becoming a Certified Pharmacovigilance Professional (CPP) is an essential step for anyone looking to build a successful career in this field. Certification demonstrates a comprehensive understanding of pharmacovigilance practices, pharmacology, regulatory guidelines, and safety monitoring of medicinal products. This certification is recognized by various regulatory bodies, ensuring that the individual is equipped with the necessary skills to contribute effectively to pharmacovigilance activities.

Certification programs typically cover topics such as clinical trial data analysis, regulatory compliance, risk management, and safety signal detection. By obtaining a CPP, professionals can position themselves as experts in pharmacovigilance, improving their career prospects and gaining a competitive edge in the job market. Furthermore, it helps professionals stay updated on the latest industry standards, safety guidelines, and technological advancements.

Computer System Validation (CSV): A Critical Component

As pharmacovigilance processes become increasingly digitized, professionals need to ensure that the systems used for managing sensitive drug safety data are reliable, compliant, and secure. This is where Computer System Validation (CSV) becomes vital. CSV is the process of ensuring that computer systems used in regulated industries, such as pharmaceuticals and healthcare, are functioning as intended and comply with regulatory requirements.

In pharmacovigilance, CSV ensures that the systems used for collecting, processing, and storing adverse event data adhere to industry standards like 21 CFR Part 11 (for electronic records) and Good Automated Manufacturing Practice (GxP) guidelines. This validation process involves rigorous testing, documentation, and continuous monitoring to confirm the accuracy, integrity, and security of the systems.

For pharmacovigilance professionals, understanding and implementing CSV practices is essential to maintain data integrity and meet regulatory requirements. Professionals need to be proficient in working with validated systems to ensure the quality and consistency of pharmacovigilance data, which directly impacts patient safety and regulatory compliance.

Conclusion

To excel in the field of pharmacovigilance, professionals need to possess a solid understanding of both safety monitoring and the technical systems used to support these processes. Becoming a Certified Pharmacovigilance Professional and gaining expertise in Computer System Validation for Professionals are two critical steps toward ensuring the reliability, efficiency, and regulatory compliance of pharmacovigilance activities. With the healthcare industry becoming increasingly data-driven, these qualifications not only enhance professional expertise but also play a crucial role in safeguarding public health and advancing the overall safety of medicinal products.

[zenovelsworld]

Zenovel delivers comprehensive CSV services, crucial for pharmaceutical and clinical trial success. We specialize in ensuring your CSV computer systems meet rigorous regulatory standards, vital in today's digital landscape. Our expertise addresses the unique challenges of CSV in pharma, where data integrity and compliance are paramount. We meticulously validate software and hardware, minimizing risks associated with data breaches and regulatory non-compliance. Our process ensures your systems are robust, reliable, and compliant with global regulations, safeguarding your critical data and streamlining your operations. Zenovel's tailored solutions help you navigate the complexities of CSV, enabling efficient and compliant clinical trials.

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Computer System Validation | Pharma Connections

Enhance your skills with our **Computer System Validation Training Courses** designed for beginners and experienced professionals in the pharmaceutical industry. Get certified with our online training that includes comprehensive assessments. Enroll now to boost your career in Computer System Validation!

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Cybercriminals are abusing Google’s infrastructure, creating emails that appear to come from Google in order to persuade people into handing over their Google account credentials. This attack, first flagged by Nick Johnson, the lead developer of the Ethereum Name Service (ENS), a blockchain equivalent of the popular internet naming convention known as the Domain Name System (DNS). Nick received a very official looking security alert about a subpoena allegedly issued to Google by law enforcement to information contained in Nick’s Google account. A URL in the email pointed Nick to a sites.google.com page that looked like an exact copy of the official Google support portal.

As a computer savvy person, Nick spotted that the official site should have been hosted on accounts.google.com and not sites.google.com. The difference is that anyone with a Google account can create a website on sites.google.com. And that is exactly what the cybercriminals did. Attackers increasingly use Google Sites to host phishing pages because the domain appears trustworthy to most users and can bypass many security filters. One of those filters is DKIM (DomainKeys Identified Mail), an email authentication protocol that allows the sending server to attach a digital signature to an email. If the target clicked either “Upload additional documents” or “View case”, they were redirected to an exact copy of the Google sign-in page designed to steal their login credentials. Your Google credentials are coveted prey, because they give access to core Google services like Gmail, Google Drive, Google Photos, Google Calendar, Google Contacts, Google Maps, Google Play, and YouTube, but also any third-party apps and services you have chosen to log in with your Google account. The signs to recognize this scam are the pages hosted at sites.google.com which should have been support.google.com and accounts.google.com and the sender address in the email header. Although it was signed by accounts.google.com, it was emailed by another address. If a person had all these accounts compromised in one go, this could easily lead to identity theft.

How to avoid scams like this

Don’t follow links in unsolicited emails or on unexpected websites.

Carefully look at the email headers when you receive an unexpected mail.

Verify the legitimacy of such emails through another, independent method.

Don’t use your Google account (or Facebook for that matter) to log in at other sites and services. Instead create an account on the service itself.

Technical details Analyzing the URL used in the attack on Nick, (https://sites.google.com[/]u/17918456/d/1W4M_jFajsC8YKeRJn6tt_b1Ja9Puh6_v/edit) where /u/17918456/ is a user or account identifier and /d/1W4M_jFajsC8YKeRJn6tt_b1Ja9Puh6_v/ identifies the exact page, the /edit part stands out like a sore thumb. DKIM-signed messages keep the signature during replays as long as the body remains unchanged. So if a malicious actor gets access to a previously legitimate DKIM-signed email, they can resend that exact message at any time, and it will still pass authentication. So, what the cybercriminals did was: Set up a Gmail account starting with me@ so the visible email would look as if it was addressed to “me.” Register an OAuth app and set the app name to match the phishing link Grant the OAuth app access to their Google account which triggers a legitimate security warning from no-reply@accounts.google.com This alert has a valid DKIM signature, with the content of the phishing email embedded in the body as the app name. Forward the message untouched which keeps the DKIM signature valid. Creating the application containing the entire text of the phishing message for its name, and preparing the landing page and fake login site may seem a lot of work. But once the criminals have completed the initial work, the procedure is easy enough to repeat once a page gets reported, which is not easy on sites.google.com. Nick submitted a bug report to Google about this. Google originally closed the report as ‘Working as Intended,’ but later Google got back to him and said it had reconsidered the matter and it will fix the OAuth bug.

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Computer System Validation | Pharma Connections

Enhance your expertise with our Online Computer System Validation Training Courses at Pharma Connections. Ideal for both beginners and experienced professionals, our courses include assessments and certifications. Enroll now to advance your career in Computer System Validation.

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Pill AOI case study, machine deep learning for pharmaceutical manufacturing