PharmOut’s validation services is supported by the fact that PharmOut is a leading employer of well trained and experienced Validation Scientists and Engineers. We can offer Validation Consultants and/or Validation Contractors to support you throughout the validation life cycle projects. They will use a risk-based approach to focus scarce resources only on what needs to be validated to ensure product quality and patient safety. These services can be offered on both a fee for service basis and a fixed price basis any where in the world.
Whether it is an existing facility, or a brand new facility manufacturing pharmaceuticals, medical devices or biologics; our consultants can navigate their way through the regulations and help you set up a compliant system in which you can have confidence.
When you need ‘hands on deck’ to do the work associated with validating your processes, equipment and systems, we have many capable and professional validation contractors to choose from.
PharmOut are the largest employer of Validation Engineers in the Asia Pacific and are leaders in thinking about new and innovative ways to approach validation. Our engineers can navigate their way through the regulations and help you set up a compliant and practical validation approach in which you can have confidence.
PharmOut offers a wide range of equipment commissioning and qualification services – if you have a new piece of equipment it is highly likely we have seen it before! Our consultants will use their experience to ensure that Critical Quality Attributes and Critical Process Parameters are identified and considered during the equipment validation.
PharmOut is aligned with the thinking in ICH Q8, Q9 and Q10 and we believe that all process validation should start with a through understanding of how the process works before starting validation.
Computer Systems Validation
We have Computer System Validation consultants, engineers and specialists who can assess your computer systems compliance assessment or validation against regulatory and industry standards.
PharmOut offers services to validate the cleaning of equipment used in manufacturing pharmaceuticals (a critical part of a process validation checklist!) which allows you to outsource this time consuming task to experienced validation contractors.
GMP Temperature Mapping
There’s an increased regulatory emphasis on GMP temperature mapping requirements for controlled temperature storage and PharmOut has both the equipment and experienced professionals to help you achieve compliance in this area.
SharePoint Validation, Qualification, Certification
SharePoint is one of the mostly widely installed software platforms within companies around the world. We have found that SharePoint can be used as a cost effective electronic Quality Management System (eQMS) or electronic Document Management System (eDMS) suitable for use by regulated companies like pharmaceutical manufacturers.
Our partners, Qiksolve, have developed the Ibiqs system which is an integrated suite of modules developed using SharePoint that streamlines, automates and allows the effective management of the quality processes that are required in a GMP or ISO management system environment.
If you have any questions you would like to ask, please contact us contact us at one of our offices around the world.
If you want to read more about qualification and validation, why not check out our blogs?