Validation Services

R.S NESS Group offers a variety of Validation and Qualification services including documentation creation, consulting, Validation Planning & Implementation for Processes, Equipment, and Systems. We are leaders in providing Validation Services to a variety of industries in the Life Science network (Pharma, Biotech, Medical Device, Foodtech, and Cannabis), ranging from start-ups to international companies.

Our Services at R.S NESS - Solutions for Life Science companies

Validation Scope

Validation is a key step in going to market. Our highly skilled professionals are here to provide solutions to your every need and industry. Our capabilities include the following but are not limited to:
  • HVAC, Facility and Clean Room Validation
  • Equipment and Machinery Validation
  • Water System Validation
  • Gas Systems Validation (OFA, CAS)
  • Validation and Verification (V&V) including Software
  • Test Method Validation (TMV)
  • Software (Computer Systems) Validation- CSV
  • Cleaning Validation
  • Process Validation
  • Sterilization Validation
  • Packaging and Shipping Validation
  • Thermal Mapping
Our Services at R.S NESS - Solutions for Life Science companies

Validation Consulting Services

We have extensive experience and knowledge to help you navigate the entire validation process, using our know-how to help your company reach their goals. Allow us to help you with the following:
  • Project management, from project initiation to production
  • Validation planning, remediation, and optimization
  • Validation methods and processes according to regulatory requirements
  • Deviation management and closure
Our Services at R.S NESS - Solutions for Life Science companies

Validation Documentation

Our talented team of experts are here to help you with Validation document creation and review. We specialize in providing a high-quality and accurate service on all documentation required for your project, including but not limited to:
  • Validation Plans and Procedures, such as a Master Validation Plan (MVP)
  • Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports, including statistical analysis
  • Risk, Gap, and GxP Assessments
  • User Specification Requirements (URS)
  • Design Qualification (DQ),
  • Factory Acceptance Testing (FAT),
  • Site Acceptance Testing (SAT) protocols and reports

Validations - New sterile R&D suite including vials & syringes

         ➢ Filling lines (vials + syringes)
         ➢ Autoclaves
         ➢ Compounding vessels (including CIP/SIP systems)
         ➢ Washing machines
         ➢ Temperature mapping (Refrigerators , Freezers , Incubators, more…)
         ➢ Critical systems (HVAC, WFI, Pure steam , Gases )

Validations - Transferring one site to new site 

Validating entire biosimilar facility that includes critical systems,
equipment and providing all quality services for the project

New R&D site – RS Ness were responsible for all validation activities including:

 ➢ Bioreactors
 ➢ Centrifuge 
 ➢ Autoclaves
 ➢ Incubators, Freezers , Refrigerators , Cold rooms.
 ➢ Washing machine
 ➢ Biological Hoods
 ➢ Critical systems
  • Facility & HVAC
  • Purified Water (PW) & SW
  • Pure steam 
  • Gases (CAS,N2,O2,CO2)

Total units – 126 units of Equipment

Upgrading Coating Room

Upgrading coating room and installation of new coating machine
(Thomas Engineering – Flex 500) including 2 sizes of drums (150 & 350 liter)

  • Design Management
  • Construction Management in an operating facility
  • Equipment Characterization and Procurement Management
  • Implementing all EHS requirement of working in ATEX area and high potency
  • Facility Upgrades and Utility systems üHVAC changes üFacility (Clean rooms modification for new design)
    üPurified Water (New user points) , compressed air , nitrogen , electricity , breathing air, industrial steam.
    üCooling and heating system
  • Validation Execution– VMP , Protocols , testing and reports
Contact Us
Contact us and we will be happy to meet and assist you with your needs