Services

Services

We provide Contract Validation Services, Consultancy and cGxP Training. Our Validation Engineers and Specialists can write Validation Plans, Specifications and Qualification Protocols for Cleaning Validations, Equipment Validations and Process Validations.

Validation Resources Ireland works across both Europe and the US providing professional, efficient and cost effective services.

Call us today  for a consultation to discuss your business requirements.


Process Validation

Our Process Validation Services can provide you with the following deliverables:

  • Validation Master Planning
  • Validation SOPs
  • Validation Protocols
  • Validation Summary Reports

Our Knowledge Products can provide customers with a platform to quickly and successfully validate their manufacturing processes. Services can be tailored to meet individual equipment, manufacturing processes or software applications.


Equipment Validation

Our Knowledge Products and Templates are effective tools in completing validations on time and with low risk by using our templates and guidance documents. 

We also offer expertise in writing user requirements specifications (URS) and Equipment factory acceptance tests (FATs)  


Cleaning Validation

Our services include Cleaning validation documentation and support. We have particular expertise in Cleaning validations for Medical Devices.

We provide:

  • OQ  & PQ Protocols
  • Process Development Support

Outsourcing

Validation Resources can provide on-site Validation Engineering as required by your organisation. The role of validation in the regulated industry is central to success. However, many companies are increasingly integrating validation activities into Quality departments. 

If you wish to be flexible with your approach to validation then Validation Resources can be of service to you.


ISO Management and Business Systems

Do you want to implement and maintain ISO 9001 or  ISO 13485 Certification within your company?

Validation Resources Limited works with companies to take the journey to formal Certification.

ISO 9001 is a Quality Management System that is used across various different industries to grow and improve businesses. It fosters continuous improvement and measuring and responding to customer requirements. 

ISO 13485 is the Medical Device Standard for manufacturers of Medical Devices.


We also  offer an Enterprise Software Solution which provides an integrated Customer Relationship Management (CRM) system and Order Processing capability.

The structure of such projects depends on your requirements but can include two main elements- (1) ISO roll-out/implementation (2) Business Systems Provision (CRM, Ordering System, website and payment portals)

More specifically a package can be designed to suit your needs, some typical deliverables include: 

-Fact Finding Audit  completed onsite
-Training on ISO 9001 or ISO 13485
-Preliminary Assessment of Operations to scope out ISO Standard Implementation
-Onsite Support for up to 10 weeks (1 day per week) to assist in implementation plan
-Pre-Audit Readiness Dry Run


-Introduction of CRM System
-Order Processing Enterprise Software
-Website 
-Payment Gateways

For further information, please contact us with your business type and a brief profile of your company

Request information

For more information, please feel free to contact us.

 Process Validation Course “I thoroughly enjoyed the course and thought it was well presented”

Karl Walsh, Bsc (Hons) / Waterford City

Process Validation Course -“An insight into the requirements of  medical device manufacturing, practical with real life examples of how to implement the theory discussed.Very professional, I look forward to the next course."

M. Doyle-Kent / Department of Engineering Technology, W.I.T

Process Validation "genuinely interesting and will help me in my future work"

T. Bamboolal / Researcher, University of Leeds