AI and non-AI validation technologies for Life Science companies

Product Description

We specialize in IA and non-AI Computer System Validation, equipment validation, utilities qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, and other key Life Science authorities across Europe and the Americas. With a proven track record of supporting over 200 clients through more than 1,000 validation projects, we are a trusted partner in the field.

FIVE Validation B.V

  • NL
  • 2023
    On CPHI since
  • 1 - 24
    Employees
Company types
IT/Software solution provider
Other
Start-up
Primary activities
Technology
Specifications
  • Details
    • Digital and agile framework with excellent cost-benefit, backed by extensive expertise in validation.
    • Templates for AI and traditional technologies
    • We facilitate the transfer of know-how during validation projects between FIVE and our clients, leveraging our familiarity with the GO!FIVE® tool
    • Our team is equipped to maximize the potential of agile and digital validation, utilizing built-in AI and non-AI libraries that expedite delivery while ensuring consistent validation
  • Model
    Service provision
  • Supplied from
    Brazil; Netherlands

FIVE Validation B.V

  • NL
  • 2023
    On CPHI since
  • 1 - 24
    Employees
Company types
IT/Software solution provider
Other
Start-up
Primary activities
Technology

More Products from FIVE Validation B.V (11)

  • AI Validation and Computer System Validation for Traditional Technologies using a digital and agile approach

    Product AI Validation and Computer System Validation for Traditional Technologies using a digital and agile approach

    We specialize in AI validation, Computer System Validation for traditional technologies, equipment validation, utility qualification, and IT/OT infrastructure qualification using digital and agile approach. Our services comply with the regulatory standards of the EMA, FDA, WHO, ANVISA, and other key Life ...
  • Equipment and Utilities Qualification, digital and agile method

    Product Equipment and Utilities Qualification, digital and agile method

    We specialize in equipment validation, utility qualification,, AI and non-AI Computer System Validation, IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, ANVISA, and other key Life Science authorities across Europe and the Americas. We are a truste...
  • GO!FIVE Digital Validation Solution

    Product GO!FIVE Digital Validation Solution

    Global Verification & Validation is a SaaS solution for Life Science companies that complies with EMA/FDA. FIVE Validation developed a SaaS platform that allows AI and traditional validation studies to proceed 6x faster than a manual (electronic or paper-based) process.
  • GO!FIVE: Digital Validation Solution, agile method, VLMS

    Product GO!FIVE: Digital Validation Solution, agile method, VLMS

    • 6x faster • Agile Framework • Automatic Traceability Matrix • Access several contents and libraries • Automatic document formatting • Get it right the first time • Off-the-shelf system • Quick and free deployment
  • IT and OT Infrastructure Qualification, digital and agile method

    Product IT and OT Infrastructure Qualification, digital and agile method

    We specialize in IT/OT infrastructure qualification, AI and non-AI Computer System Validation, equipment validation andutilities qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, ANVISA, and other key Life Science authorities across Europe and the Americas. We are a tru...
  • Validation of AI and non-AI technologies for Life Science companies, digital and agile method

    Product Validation of AI and non-AI technologies for Life Science companies, digital and agile method

    We specialize in AI and non-AI Computer System Validation, equipment validation, utility qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, ANVISA, and other key Life Science authorities across Europe and the Americas. We are a tru...
  • AI and non-AI Computerized System Validation, agile and digital method

    Product AI and non-AI Computerized System Validation, agile and digital method

    We specialize in AI and non-AI Computer System Validation, equipment validation, utilities qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, ANVISA and other key Life Science authorities across Europe and the Americas. With a ...
  • Equipment Validation, agile and digital method

    Product Equipment Validation, agile and digital method

    We specialize in Computer System Validation, equipment validation, utilities qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, ANVISA and other key Life Science authorities across Europe and the Americas. With a proven track r...
  • IT and OT Infrastructure Qualification

    Product IT and OT Infrastructure Qualification

    Global Verification & Validation is a SaaS solution for Life Science companies that complies with EMA/FDA. FIVE Validation developed a SaaS platform that allows validation studies to proceed 6x faster than a manual (electronic or paper-based) process.

  • IT and OT Infrastructure Qualification

    Product IT and OT Infrastructure Qualification

    FIVE resources have access to the GO!FIVE® digital validation software at no additional cost, accelerating the validation process and ensuring transparency. You can track the project's progress in real-time, enhancing communication and decision-making.

    For software validation, all validat...
  • Validation of AI and non-AI technologies for Life Science companies

    Product Validation of AI and non-AI technologies for Life Science companies

    We specialize in AI and non-AI Computer System Validation, equipment validation, utility qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, ANVISA, and other key Life Science authorities across Europe and the Americas. We are a ...

Frequently Viewed Together

  • Product Thermal Mapping

    We protect the integrity and quality of your temperature sensitive pharmaceutical products to meet all regulatory requirements

    PharmEng Technology has developed standards and methods to perform thermal process ratings according to your specifications. Our professionals are equipped with the righ...
  • Product Auditing

    Our pharmaceutical auditing and management services give you a transparent view of your supply chain enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes. Through our shared audit programs, delivered by our global network of specialist audit...
  • Product Computer System Validation (CSV) Solutions

    ProPharma's validation professionals leverage the latest risk-based Computer System Validation (CSV) and Computer Software Assurance (CSA) techniques to ensure that our clients' systems are ready for inspections from the FDA, EMA, MHRA, and other regulatory agencies. Our consultants have extensive experien...
  • Product Quality - QEdge - Enterprise Quality Management Suite

    Sarjen Systems' QEdge is an enterprise-wide Quality Management System (QMS) specifically designed for pharmaceutical manufacturing. This risk-based QMS offers a comprehensive suite of solutions, including:
    • Process Control • Document Control & Issuance • Training Management System • Ve...
  • Product USFDA Compliance & Regulatory

    Preparing for a USFDA Inspection and managing the post inspection situation requires a high level of expertise and PharmSol offers a comprehensive solution in that direction.-Compliance Management
    -Product Development
    -Regulatory Support
    -BD Support
  • Product Life Science: Computer System Validation

    Validation of computerized systems (CSV) according to GxP Guidelines has been a basic requirement in the life science industry for many years now. However, as the complexity of the IT landscape and the degree of automation has increased, the effort required to keep compliance has risen as well. Of cour...
  • Product Audits

    Due to recent regulatory developments concerning raw materials, suppliers, manufacturing and distribution, auditing has become a task of critical importance for Life Science businesses.PQE Group supports Pharma and MD companies in performing many types of certified audits, from routine monitoring to due di...
  • Product Commissioned GMP Audits

    Rephine's commissioned audit service gives our customers the opportunity to work with us to design exclusive audits tailored to the specifics of their operations. Customers can commission various audits including:

    -API Manufacture-Excipient Manufacture
    -Investigational Medicinal Product (IMP) M...
  • Product TechFile-Manager

    IntroductionGruppo SASI's offer for the management of the Technical File for Medical Devices is developed in full compliance with the legislation in force for the European community as illustrated in the REGULATION (EU) 2017/745 and 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 201...
  • Product GMP Services(Good Manufacturing Practices)

    We offer various GMP services which can help the clients across globe, ranging from audits to various consulting services.

    We provide following comprehensive GMP Quality Compliance services to the pharmaceutical industry.

    • Audits 

    • API Audit Reports 

    • QMS/Complia...
  • Product DataCollector - High performance IT Infrastructure for Manufacturing

    The plus10 DataCollector provides a high-performance data infrastructure for the acquisition and pre-processing of machine data from any source such as sensors, machine or robot controllers. Its simple configuration and implementation transforms machine data into Big Data and creates value through high-fre...
  • Product SLIMStat - Shelf-Life Projection Software

    SLIMStat is extremely easy-to-use software developed and validated specifically to determine the shelf life of drug products that have been placed on stability. This interactive and intuitive tool empowers non-statisticians the ability to generate statistical analyses with complete confidence. Fully v...
  • Product Sterilization services by GEMÜ

    GEMÜ offers a holistic approach to the implementation, validation, and management of sterilization processes, ensuring full regulatory compliance and process reliability. We serve as a strategic partner for manufacturers in medical technology, pharmaceuticals, and biotechnology, providing end-to-end steril...
  • Product GO!FIVE Digital Validation Solution

    Global Verification & Validation is a SaaS solution for Life Science companies that complies with EMA/FDA. FIVE Validation developed a SaaS platform that allows AI and traditional validation studies to proceed 6x faster than a manual (electronic or paper-based) process.
  • Product Custom Protein Synthesis

    We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...
  • Product Cortellis Drug Discovery Intelligence™

    Biology, chemistry and pharmacology data -all in one place. Accelerate drug development with early, comprehensive intelligence. Collating the necessary data to identify the likelihood of a drug's success as early as possible requires considerable resources. Cortellis Drug Discovery Intelligence(TM) ...
  • Product Quality Management System

    MasterControl Inc. is the most trusted provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is to help our customers bring life-changing products to more people sooner. MasterControl Quality Excellence is our flagship quality management syste...
  • Product Automatically tracking children's medication

    As a busy parent, managing a child's medication can be hard. Team Consulting integrated connectivity into a syringe to help parents keep track of their child's medication through a smartphone app.

    Using a small, low-cost sensor, this connected syringe automatically tracks when and how much drug...
  • Product Verify Brand (L4)

    POWERFUL SERIALIZATION AND TRACEABILITY SOLUTION FOR L4-L5, NOW PART OF THE OPTCHAIN™ PLATFORM OPTEL's L4-L5 serialization software, a powerful, enterprise-level serialization and traceability solution, has helped the world's best-known brands protect their assets. Optchain Verify is an essential tool ...
  • Product Autoinjector development services

    SHL Medical's commitment to innovation has driven our leadership in the drug delivery industry. We offer vertically integrated development services to ensure the production of our self-injection systems are delivered with unparalleled speed, quality, and reliability. 
  • Product SoftGroup® SaTT EU Hub Gateway

    SoftGroup® SaTT EU Hub Gatewayoffers an upload/update of PMD (Product Master Data) and PPD (Product Pack Data) to the EU HUB (EMVO). Via this Cloud solution, the MAH / Parallel distributor could select which serialized batch should be reported to EMVO. The system allows status verification o...
  • Product Laser Drilling Positive Controls in CCIT

    Oxford Lasers is a world-class supplier of precision laser-drilling to create positive controls in container closure integrity testing (CCIT). Positive controls are created by drilling a known, measured micro hole in a package. These are used in the production process to provide deterministic proof that ...
  • Product Supplier audits

    Critical supplier audits performed by industry experts.
  • Product Development

    Synerlab provides wide range of services which includes development. Contact us for more information.
  • Product Blister Change Parts

    We are manufacturing all type of blister & Alu Alu change parts for all standard Blister Machine
  • Product Inspection Readiness & Support

    • Inspection Event Planning • Personnel Training and Interview Preparation • Subject Matter Expert Support • Post-Inspection Analysis
  • Product GMP-Support: Qualification / Validation / Consulting

    Quasaar does not see itself as "processing office" of service contracts.

    As an outsourcing partner, Quasaar also focuses on problem solving, increasing efficiency and process optimization, including on-site consulting and project management.
    Our expertise includes i.a. following topics: ...
  • Product PLÜMAT Leak Detection

    This semiautomatic leak detection system is designed to serve in offline sample testing of filled solution bags to verify the bag tighness.

    For this purpose, a vacuum test method which is gentle on the product and packaging is used. This integral vacuum test is non-destructive and ha...
  • Product OC11 Word Platform

    The OC 11 Platform is not just another software; it's the next generation of Global GxP and Data Integrity solutions. It's designed to revolutionize how GxP records are generated and to ensure users comply with global GxP and Data Integrity regulatory requirements..

    Convert any Word form i...
  • Product Biocatalyst production

    Is the enzyme you are interested in not commercially available and a production needs to be developed? Enzymicals has extensive expertise with scale-up from lab to pilot-scale and technology transfers to industrial manufacturing sites. We can supply your protein by in-house production up to the kg-scale...
  • Product Counting station (reconciliation, position detection)

    Machine learning based flexible tool that can: • count, • detect shapes, • detect mix-ups, • reconciliate. We can adjust our algorithm for very specific needs that your production struggles with. The most universal use is to count samples like vials, syringes, blisters. Other business cases include mult...
  • Product QUALIPHARMA

    Qualipharma is a consulting company created in 2001 and specialized in GMP&GDP advisory and consultancy services for healthcare and pharmaceutical sectors. Nowadays, our company is made up by a team of 80 experienced professionals that guarantees the highest quality customer service experien...
  • Product e-Reg: management of Regulatory Affairs' big data

    OP Pharma has been providing all-around services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.

    Do you have lots of products and/or products' data which you cannot organize/archive interna...
  • Product COMPLIANCE

    AUDITING: - Support its clients on Vendor Audit; COMMISSIONING:- Manages and performs commissioning activities for new systems, equipments and facilities; 
    TESTING:- Performs the following testing activities using its own instrumentation saving costs and time on tests planning; 
    COMP...
  • Product Drug Development Consulting

    Our Drug Development Consultants work with you to design and implement successful drug development programs. With industry leading scientific expertise across a range of technical disciplines, we help customers across all stages of development, from candidate selection to commercial launch.

    Our cons...
  • Product Validation

    CSV Group high skilled team supports a wide range of GxP critical environments, with profiles dedicated to strategical GxP Activities for Risk Management as well as to computerized Systems and Data Integrity.

    COMMISSIONING
    • FAT/SAT assistance/ support • System balancing and troublesho...
  • Product Fully integrated high-speed line for IV-Bags

    IVB-40 is designed to handle a wide range of plastic IV-Bag containers, from 50ml to 1000ml, with precision and efficiency. This advanced system offers a fully customizable loading and unloading process, tailored to meet specific customer requirements, ensuring seamless integration into your production lin...
  • Product Reference Materials Management Services

    To support you in bringing even safer medicines to the market, we go far beyond supplying you with the right reference standards. From impurity profiling and working standards outsourcing services, all the way to managing inventory and logistics of your reference standards, we're fully equipped to provide ...
  • Product Automated Headspace Analysis

    The verification of quality relevant attributes of the headspace conditions e.g. in lyophilized and liquid filled vials, requires non-destructive and robust inspection technologies. The SPECTRA HSX platform is designed to meet the highest requirements in terms of sensitivity and throughput for automated He...
  • Product Rommelag Pharma Service

    With Rommelag Pharma Service, we offer those who purchase a bottelpack system a quick and economical complete concept for qualification and validation, which is recognized by the authorities. We know what matters and can perform the entire process more cost-effectively, successfully, and reliably than you....
  • Product Purcision™ - Platform for Direct to Target Drugs

    Purcision™ is a proven particle engineering technology used to develop new drugs and reformulate and repurpose existing drugs for multiple delivery systems.
    • Purcision technology is different from other particle engineering technologies (CESS, RESS, spray drying, milling)
    • Purcision technology ...
  • Product Value-added generic development

    Avivia offers full product development services to generic drug companies and specialty pharma focused on the development of new improved versions (value-added generics or generic plus) of established drug products.
    Although in general the overall aim of value-added generic development projects is focu...
  • Product Active Alignment Assembly & Test Platform

    Protect your Brand with Active Alignment Achieve high throughput and high-precision manufacturing using today's state-of-the-art optics. Active alignment is the most dependable method for smart assembly, because it is a dynamic process. During active alignment, a system's power is being manipulated while s...
  • Product Vision inspection systems for pharmaceuticals

    The quality control of the drugs and their packaging is essential to reduce risks of defective products, but also to automatize the production processes.

    SEA Vision has been developing industrial machine vision software for the pharmaceutical industry since 1995. Today the vi...
  • Product ANDA and NDA Technical Support

    As part of its commitment to full service support, Avéma Contract Services is pleased to offer our customers support with ANDA and NDA applications, including bio equivalency studies, collecting background data, supervising technology tranfers and reviewing applications to make sure that companies com...
  • Product SART System™ Enables a Sterile Liquid Transfer

    Secure Your Drug Product Transfer

    The SART System™, a smaller footprint RTP system (Rapid Transfer Port), preserves the integrity of your isolator and creates a sterile transfer of your drug product. The reduced footprint of the SART System™ meets the challenge of ergonomic optimization ...
  • Product Medical Device Assembly, Testing and Packaging

    DESOTEC offers all Services and Equipment for medical deive assembly, testing and packaging. This could be opthalmic devices, nasal devices, injectors, etc
  • Product CCI Container Closure Integrity Testing for Laboratory E-Scan MicroCur...

    The E-Scan 615 technology is a revolutionary CCIT (container closure integrity test) instrument that utilizes a new class of HVLD technology, MicroCurrent to inspect vials, syringes, and other liquid filled parenteral products for container closure integrity.


    The E-Scan 615 provides a...
  • Product Vacuum insulated cooling box VIXELL

     Engineered for the cold supply chain - with built-in wireless vacuum sensor

    Designed to meet the challenges of cold chain transportation for biopharmaceuticals, investigational drugs and vaccines that require strict temperature controls, VIXELL features patented vacuum insulation and healt...