iNova Pharmaceuticals (“iNova”) is an international organisation that develops, markets and sells a wide-range of prescription medicines and non-prescription consumer health products to over 20 countries across Asia, Australia and New Zealand, and Africa. Employing over 500 industry professionals over 3 continents, iNova’s vision is to deliver trusted, market-leading brands that improve people’s health and well-being everyday. iNova’s broad product portfolio spans therapeutic areas including weight management, cough, cold & flu, pain management, health supplements, dermatology, sun care and female health products.
Following a business separation from a much larger parent organisation, iNova undertook a business review to assess the systems and procedures for its new operation. iNova identified the need to develop a Computer System Validation (CSV) operating model, to support governance, and provide overall robustness to its process and procedures related to IT systems and infrastructure impacting product quality.
From this business requirement, iNova approached SeerPharma to help define its strategic approach to CSV. SeerPharma was engaged to help define an overall operating model, which included:
- Review of CSVMP and existing SOP’s
- Reviewing and updating the current framework of CSV documentation
- Writing / updating content for Procedures Forms and Guidelines within the CSV framework
- Review and update (as required) the CSVMP
- Review and update (as required) the IT Infrastructure Qualification Plan
- Assistance with Impact Assessments, Gap Assessment, and remediation planning
SeerPharma was also tasked to conduct a gap assessment of all relevant IT systems at iNova , to determine the validation efforts required and the risk category they belonged to meet the regulatory requirements of US FDA 21 CFR Part 11 and TGA Annex 11. In addition, Seerpharma mentored and trained iNova personnel on the structured approach to CSV, to enable iNova to manage its system and validation requirements in the future.
“SeerPharma have been an absolute pleasure to work with. CSV is an extremely important capability area for us at iNova and during delivery of an extensive application program it is paramount to ensure all of our GxP systems are compliant with the regulatory standards. SeerPharma have provided us with a combination of highly valuable collateral and advice that has catalysed our journey towards a gold-standard CSV capability. The team have been available, knowledgeable and accommodating. We would not have been able to undertake this journey without them.”
Michael Smit, Associate Director – Technology and Business Transition
iNova Pharmaceuticals
SeerPharma has deep and significant experience in managing regulatory GxP requirements for IT systems used by Pharma and Med tech companies in the APAC region. With deep expertise in Computer System Validation (CSV), contact us should you require guidance on industry best-practices for your business.
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