VALIDATION OF COMPUTER-BASED PHARMACEUTICAL EQUIPMENT
The support you need for project success
About us
The prevalence of computer-based equipment in pharmaceutical process and packaging halls has increased rapidly over the past twenty years, requiring particular expertise to ensure it complies with the design and construction requirements of cGMP.
Most machinery now has integrated computer technology, complete with an operating system, incorporating advanced user administration with access control, disaster recovery implementation and audit trail operation. Similar computer systems will also be found in most ancillary equipment, such as printers, bar code readers and vision systems.
Established in 2008, Performance PharmaTech has focused exclusively on this area of validation and today has a number of specialist pharmaceutical regulatory consultants.
We draw on our understanding of the pharmaceutical regulatory environment to create solutions and provide documented evidence which provides a high degree of assurance that systems, operated within their specified design parameters, are capable of repeatedly and reliably producing a finished product of the required quality.
This approach addresses the challenges typically faced by end user and supplier respectively:
This presents a number of challenges to both supplier and end user:
For the equipment specifier and purchaser:
how to specify computer-based equipment to meet the specific requirements of GAMP® classification, determining validation approach, implementation, followed by ongoing software support, hardware support, training and ERES issues.
For the pharmaceutical equipment supplier:
how to configure the equipment then create suitably structured validation packages in accordance with the pharmaceutical industry’s unique requirements. How to know what additional technical and regulatory support is required to answer customer questions, from both user requirement sources and during project development. Additionally, how to pass a customer audit of your company when requested.
Paul Osborne, Managing Director
Understanding how to employ and integrate computer technology in pharmaceutical process and packaging areas in a pragmatic and cost-effective manner is crucial to developing a proactive and unified strategy for success.
Our services
Core Services
Performance PharmaTech exists to support suppliers who wish to sell computer-based equipment into the highly regulated pharmaceutical environment operating under GAMP 5 guidance, as well as all other recent regulatory developments. We can help the equipment supplier in two ways:
- Development of a suitable validation documentation set. This is provided to the pharmaceutical company prior to the supply of equipment and can also be used for factory acceptance testing purposes. It is modular and can be easily reconfigured for different projects after the initial consultancy and preparation.
- Alternatively, training on the production of this material for supplier’s representatives who wish to provide this documentation directly.
Document Design and Creation
GAMP guidance aims to achieve computerised systems that are fit for their intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner – Introduction to GAMP 5 guide.
With our highly experienced team, we are your support for the creation of: Quality and Project Planning, User Requirement Specification interpretation, Functional Design Specification development, Installation & Operational Qualification development, Risk Analysis and Traceability Matrix generation.
Technical Support
We spend considerable time and effort keeping up with the latest trends in legislation – such as Annex 11 of the European GMP, Section 211.68 of the US cGMP regulations directive – and understanding the latest country-specific, serialisation guidelines. We can help you exercise appropriate documentary controls over computer or related systems in a pragmatic and cost-effective manner. We spend considerable time following trends in pharmaceutical packaging standards, evolving regulatory issues and evolving technology.
People who understand and create solutions to meet the pharmaceutical regulatory environment
Paul Osborne
Managing Director
Senior Validation Engineer
Haley Kubic
Validation
Engineer
Keith Fifield
Senior Validation Engineer
Paul Sculthorp
Validation
Engineer
Jo Wood
Validation
Engineer
What our clients say
Fabien Ramat
Anti-doping Testing Manager for Cycling at International Testing Agency
I first contacted Paul so he could train a few people at GW on the future of the FMD. Then we car- ried on working with Paul so he could help us on the design and implementation of a new pack- ing line including serialization. Paul has been a great support and driver in helping find the right technology for us. He was able to propose a solution that fitted a small-scale operation like ours.
Ray Johnson
Founder, Exit Experts
Paul demonstrated an exceptional ability to comprehend complex technical challenges and to de- velop uniquely creative solutions that were time and cost effec- tive. In addition to his extremely high technical competency, Paul also has a tremendous work ethic. I do not hesitate giving Paul my highest recommenda- tion both for his technical prob- lem solving and customer sup- port abilities.
Roberto Dell’Acqua
Technical Dept. Laetus
Many thanks for your IQ / OQ documents. I appreciate your experience and knowledge in the pharma field and Laetus equipment performance.
Stefano Gamberinit
Sales & Product Manager ARCA ETICHETTE S.p.A.
Thanks a lot for your support, teaching, assistance and co- operation during this important exam. Without your help, we couldn’t do anything at all and the final result would have been a disaster. This will also help us in managing future Audits, and that’s why we’re so grateful to you.
Make an enquiry
We are here to help – assistance is just one click or call away.
The information you supply will be used for the purposes of contacting you and to provide you with information that is relevant to Performance PhamaTech.