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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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.
Claire Myerson - CIO Nuffield Health
The team at Agile really are expert in all areas of IT regulatory compliance, risk and quality management. I have worked with them on a number of audit and IT governance related assignments over the past few years and I would not hesitate in recommending them to any CIO who needs specialist support from hardworking professionals.
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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