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| Northern Ireland |
7 Mourne Wood, Kilbroney Road
Rostrevor, Newry Co. Down
BT34 3GG
Tel: +353 (0)48 417 39162 |
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| Republic of Ireland |
33 Connell Drive
Newbridge Co Kildare
Tel: +353 (0)48 417 39162 |
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| Validation Services |
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Absolute Technical Solutions provide a comprehensive validation service to our clients at every stage of the project life cycle. We can assist with all aspects of validation relating to equipment, facilities, GMP utilities and computer systems. It is our objective to support our clients in developing, implementing and achieving a validation strategy and programme that is designed to meet the customers’ timescales and budget whilst fully satisfying the cGMP requirements and the regulatory obligations of the licensing bodies.
Involvement can start from the design stages of a project i.e. during User Requirement Specification (URS) development, Design Reviews right through Vendor Factory Acceptance Testing (FAT) to site Commissioning, Installation Verification and Qualification (IQ), Operational Testing and Qualification (OQ) and Performance Qualification (PQ).
The validation services Absolute Technical Solutions can provide include, but are not limited to the activities below and will be tailored to meet the specific requirements of our clients; |
» Validation Master Plans / Validation Plans.
» Design Qualification
» Design Reviews Support
» Computer Systems Report
» Installation Qualification (IQ) Protocols
» Site Validation Execution
» Operation Qualification (OQ) Protocols
» Final Validation Summery Reports
» Performance Qualification (PQ) Protocols
» Cleaning / Sanitation Validation Protocols
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All projects are delivered with an appropriate level of Project Management, Scheduling and Cost Control Metrics to monitor progression. Operating within an integrated team approach, our aim is to minimise the risk of failures during site execution activities thus reducing expensive rework at all stages of the validation life cycle by challenging and enhancing and preceding each stage of the process, for example:- conducting comprehensive vendor document reviews to ensure that the user requirements, specifications and the cGMP guidelines have been captured by vendors and that sufficient definition is in place to support latter phases of FAT, commissioning and validation.
We can provide a spectrum of services, from developing a multidiscipline flexible team to deliver large scale expansion projects, to sourcing discrete individuals with required skills to integrate directly with the clients’ team. |
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