CASE STUDY: Post-audit Remediation and Compliance Consultancy
We began our engagement by developing a detailed IS compliance strategy, and using this as the road map for our initiatives, we overhauled the organisation; validating GxP-critical systems, qualifying the IT infrastructure, and remediating audit observations.
We ensured the sustainability of IS compliance by implementing a change control process and by documenting strategy and processes within a suite of well-written polices and procedures.
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CASE STUDY: Compliance Consultancy, Head Office of Large Pharmaceutical
Initially a department with an inadequate compliance framework and poor organisation of its IT landscape, Agile GxP helped transform it radically. By the end of our engagement, the department had a detailed inventory and regulatory assessment of all the systems it supported and was implementing changes on the applications and underlying infrastructure in a controlled and compliant manner.
The department underwent three comprehensive GxP audits, all without major observations. From an organisation sceptical of the value of IT compliance, it was developed into one where compliance was ingrained in the culture, and where Good Practice was exhibited daily.
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Pierre Covey - Head of LSB Project QA Qualification & Validation team - Merck Serono
Working for 3 years on a €400 million project at Merck-Serono's Vevey pharmaceutical biotechnology manufacturing site, Agile GxP were responsible for process automation qualification. As such they brought expertise for validation of hardware and software building such systems and valuable skills for the creation and organisation of complex technical and GMP documentation related to the activity. Mr Crutchfield built several computerised tools to manage the quantity of software modules created, corrected and re-tested until final approval. His positive attitude was key in coordinating the engineers executing the tests and liaising with the project management and Quality Assurance teams in charge of guaranteeing the appropriate level of documentation and of change control. As former head of the LSB project QA Qualification team, I thank him for his contribution to the success of the project.
Brian Collins, Associate Director - Validation, Wyeth Pharmaceuticals (2005 - 2008)
I had th epleasure of working with Clive for several years during a time when all IT based systems were being re-qualified/validated at the UK manufacturing site.
The team was very diligent in developing the right validation strategy to ensure that business objectives were met whilst respecting the requirements of the regulations that needed to be observed at the time. If the opportunity arose again to work with Clive and his team of skilled professionals, I would not hesitate.
About Agile GxP
Providing specialist IT / automation compliance and validation services to the healthcare and pharmaceuticals for 18 years.
- IT / Industrial Automation Compliance
- Project & Programme Managment
- Auditing & Audit Remediation
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