CSV

Computer system validation (CSV) is a documented process that a computer system should meet a set of defined system requirements.

Validation of computer systems is done to ensure their accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. It is a critical requirement for electronic record compliance.

Our computer system validation experts validate computer programs for all types of businesses, including pharmaceutical and biologics manufacturers, medical device manufacturers, clinical research organizations, and GLP laboratories. Regulatory agencies require the CSV process to ensure the accuracy and integrity of data in computerized systems and product safety and effectiveness. CSV should be done at the time of configuring a new system or updating an already validated system (upgrades, patches, extensions, etc.).

CSV processes should be done as per the regulations and guidelines. Best practices for the domain and the attributes of the system are being approved.

Case Study on Manufacturing/Quality Systems Validation

01

GAP ANALYSIS

Regulatory guidelines Vs Current practices/SOPs Vs Current practices.

02

REVALIDATION

Reusable documentation, CSV Validation as per 21 CFR Part 11, EU Annex 11 & GAMP 5

03

BUSINESS AS USUAL (BAU)

Conduct periodic reviews. Change Management and continuous Audit readiness.

Validation Activities under the current scope;
  • RRA - Regulatory Risk Assessment
  • FRA - Functional Risk Assessment
  • IQ - Installation Qualification
  • OQ - Operational Qualification
  • PQ - Performance Qualification
  • QRM - Quality Risk Management
  • DIRA - Data Integrity Risk Assessment
Associated with Major Indian Pharma Companies Across different locations in India Total 4000+ Systems covered ;
  • HPLC
  • GC
  • SCADA
  • HMI
  • Chromeleon
  • LabSolutions server
  • Empower
  • CDAS and
  • Serialization systems
Validation Deliverables as per current scope;
  • VMP - Validation Master Plan
  • EAR - Electronic-data Assessment Report
  • VAR - Vendor Assessment Report
  • SVP - Software Validation Plan
  • URS - User Requirement Specification
  • FRS - Functional Requirement Specification
  • DS - Design Specification
  • CS - Configuration Specification
  • RTM - Requirements Traceability Matrix
  • VSR - Validation Summary Report
  • SRC - System Release Certificate (SRS)
  • TL - Transport Log
  • PRR - Periodic Review Report

TESTIMONIALS Clients speak for us

Padmakar Jadhav

G.M. Warehouse.
Biological e Limited

Sharing my experience with Proven Tech (PT) during SAP WMS implementation. When our management decided to implement WMS for 3 vaccine plants in span of 3 months, we were looking for reliable, efficient technology partner, which we find in PT. Since beginning, PT team displayed a deep understanding of our business objectives & processes. Their expertise help use complete the project within timeline as per our business requirements. Recently visited auditors appreciated WMS system, proper documentation and its effectiveness. Overall support from PT were highly appreciable & finally our team is extremely satisfied after WMS implementation.

Anil Gopal Yellapragada,

Associate Director

I am happy to share my testimonial for our new service provider ProvenTech.
From the moment we partnered with them, we experienced a level of professionalism and dedication that surpassed all our expectations.
Their team is comprised of true experts in their field, and it's evident that they understand the business requirements and map the tailormade solutions to address day to day business user pain points. Whenever we had questions or required assistance, they were always just a phone call or email away, ready to provide prompt support. What impressed me the most was their commitment. Not only they delivered exceptional results, but they also did within the agreed-upon timeframe and budget.
I highly recommend ProvenTech to anyone seeking professional, reliable, and results-driven solutions. They have been an invaluable service provider to any organization, and I look forward to continuing this good relationship for future endeavours.

Mangesh Gupte

Sr. GM-Projects
USV Private Limited

Proventech has been associated with USV for 3 years now supporting the Serialisation -US DSCSA, EUFMD, DS & now QR code on blisters. We are happy to share our experience as a satisfied customer of ProvenTech, a company that has exceeded our expectations and has truly delivered their solutions to meet our business requirements. The team at ProvenTech demonstrated exceptional expertise, professionalism and dedication all the time. From the initial consultation to the implementation of their solutions, they exhibited a deep understanding of our business goals and objectives. Their ability to translate our complex requirements into efficient solutions through their expertise. One of the most remarkable aspects of working with ProvenTech was their commitment to providing top-notch customer service. Anytime we had a question or concern, their support team was quick to respond and resolve any issues promptly. They were patient with us and ensured that we fully understood the solutions they were implementing, empowering our team to make the most of their technology. We are fully satisfied with their support and look forward to a long-lasting association.

Kishore.

Head -QC
Neuland Laboratories Ltd Unit-1

When we have a urge to check all our chromatographic data for some of the critical aspects, Proventech team has given us a tool to verify the data and make us to complete the task with their support in very tiniest timelines. I really appreciate the team for their support though out the work , we are planning to get proventech support for all critical and time taking works. Once again thanks to the proventech team.