Computer System Validation (CSV) Services
for Life sciences industries
Risk-based validation built on US FDA, PIC/S, EU GMP, GAMP 5, CSA and other global regulations
20+ years validating GxP systems across pharma, biotech, cell & gene therapy, and medical device manufacturing.
CSV & CSA
From training to templates
Our approach is built on proven computer system validation guidelines and computer software assurance (CSA) best practices, equipping your team with modern CSV/CSA techniques.
CSV, CSA, and Data Integrity Training
General or system- specific training on ALCOA+ principles to empower your team.
Gap Assessments and Supplier Assessments
Identify and bridge compliance gaps, ensure suppliers are up to standard.
Comprehensive CSV Policies and Procedures
Implement a corporate-level policy and methodology aligned with your QMS for all types of systems, such as ERP, MES, and LIMS.
System Registration and Impact Assessment
A clear way to understand and assess the impact of all systems across your whole site, by applying a risk based methodology, aligned with GAMP 5 SE.
Validation Planning and Strategy
Implement a Validation Master Plan (VMP) and tailored Validation Plan(s) to streamline your validation process.
Risk Assessment and Modern Test Approaches
Learn to apply a range of risk assessment methodologies, from Failure Mode and Effects Analysis (FMEA) to a customised Process Risk Assessment, in a way that facilitate optimized testing strategies.
Document Templates
Leverage our document templates that include key project validation activities and SOP's.
Software Supplier Assessments to meet GxP Requirements
Ensure software suppliers implement a controlled Software Development Lifecycle (SDLC) within a QMS.
What systems do our CSV services validate or qualify?
Our CSV services validate and qualify GxP systems across IT, manufacturing, labs, supply chain, and infrastructure, from enterprise platforms to niche regulated systems.
Our risk-based approach helps ensure each system is compliant, reliable, and ready to support regulated operations.
Example systems that we validate
Lab Systems
+ Chromatography Data System software
+ HPLC
+ QC test devices
+ Excel based analytic tools
+ Lab Execution System (LES)
+ Lab Information Management System (LIMS)
Production Systems
+ Rotary Tableting Press Machine
+ Blister Packing Machine
+ Autoclave
+ Purified Water System
+ Sterile Vial filling line
+ Mixing Tank
+ Freeze dryer
+ Process Control System
Information Management Systems
+ Enterprise Resource Planning (ERP)
+ Electronic Quality Management (eQMS)
+ Manufacturing Execution (MES) & Electronic batch record (EBR)
+ Environmental/ Building Management Systems (EMS/BMS)
+ Warehouse Management System (WMS)
Production Systems
+ Cloud deployed systems
+ On-premise networks
+ IoT, OT-IT interfaces
“Factorytalk’s CSV expertise helped DHG confidently meet international audit and inspection requirements. With their support, we adopted the latest best practices and successfully prepared for EU GMP certification.
Factorytalk partnered closely with our management and project teams, enabling us to implement a practical and efficient CSV approach that ensured compliance without unnecessary complexity. We value their collaboration, whose commitment and professionalism contributed to the project’s success and strengthened DHG’s GMP knowledge and capability.”
Le Ha Ngoc Minh
Validation Supervisor, DHG Pharmaceutical Joint-Stock Company
“Factorytalk’s expert CSV training, aligned with GAMP 5 Second Edition and the latest regulatory trends, gave Schneider Electric’s global teams confidence in their compliance practices.
Their professional and insightful delivery made complex topics practical and easy to apply.”
Honghang Chen
Global Solution Architect – Life Science, Schneider Electric
“I challenged Factorytalk with co-creating an innovative risk-based CSV model for Tulip, a technology platform used globally across all sites, and to deliver it as apps managing data rather than using traditional documents.
Their mentality to partner with customers, creativity, and high quality services were instrumental in the projects success.”
Bob Buhlmann
Head of Quality Digital and Computer Strategy, AstraZeneca
Meet Our
CSV Consultants
Empowering your compliance journey with expert guidance and proven tools.
Chompunut Apinan
Senior CSV Consultant
Douglas John Isles
CSV Consultant
Frequently Asked Questions
Find answers to the questions we get asked the most. If you have questions that you can’t find the answer to. Please contact us.
CSV services typically cover the full validation lifecycle: risk assessment, Validation Master Planning, GAMP 5 classification, IQ/OQ/PQ testing, and ongoing compliance documentation.
For life sciences and healthcare companies, this scope often extendsbeyond enterprise software to lab equipment, production machinery, andnetwork infrastructure that fall under GxP oversight.
Factorytalk's CSV services cover this full range, from GAMP 5 SEclassification to inspection-ready documentation, across pharma, biotech,and medical device operations.
Implementing CSV in pharma generally follows a defined sequence: classify the system under GAMP 5, write a Validation Plan, define user requirements, execute verification testing such as IQ, OQ, PQ/UAT, prepare operational SOPs, then compile a Validation Summary Report.
Factorytalk's CSV services guide pharma teams through each of these steps.
In-house teams understand their systems well, but CSV projects can be limited by time, resources, and specialist knowledge in GAMP 5, CSA, and audit-ready documentation.
Outsourcing brings dedicated expertise and faster delivery, especially forcomplex or first-time projects. Many companies choose a hybrid model: externalsupport for key validation work, with internal training to maintain complianceafterward.
Factorytalk supports both approaches through hands-on CSV project delivery,CSV training, and data integrity training.
A strong CSV partner for medical device manufacturers needs proven experience in GAMP 5, FDA 21 CFR Part 820 and ISO 13485:2016.
Look for a firm that can provide CSV training and support you throughoutthe project to deliver audit-ready documentation rather than generictemplates.
Factorytalk brings over 20 years of GxP validation experience acrosspharma, biotech, and medical device manufacturing, spanning bothenterprise platforms and specialized equipment.
CSV project cost depends mainly on how many systems need validating,their GAMP 5 risk classification, how much documentation already exists,and whether it's a new implementation or retrospective validation.
Because scope varies this much, most CSV providers, includingFactorytalk, price a project after an initial scoping or gap assessment ratherthan quoting a flat rate.
While CSV has always been risk-based, CSA expands how that risk assessment can be applied to move away from rigid, document-heavy test execution toward critical-thinking-driven testing strategies, consistent with FDA guidance.
Factorytalk incorporates CSA principles from the start, helping your teamspend less time on unnecessary paperwork and more time confirming thatcritical systems perform as intended.
Get CSV services tailored to your systems
Tell us what you need to validate, whether it’s a new implementation,
a retrospective project, or
preparation for an upcoming inspection.
We’ll help you define the right
validation approach for your
projects.
