CSA/CSV & 21 CFR Part 11 Training for Global Diagnostics Manufacturer

The Singaporean division of a global diagnostics equipment manufacturer engaged SeerPharma to deliver training on Computer Software Assurance/Validation and 21 CFR Part 11. Multiple workshops were delivered to over 50 staff, to help them appreciate the regulatory expectations of the US FDA , for the work performed on-site.

The CSA/CSV workshops from SeerPharma discussed the background of Production, Process and Quality System Software Validation. In addition, addressed the similarities and differences between CSA and traditional software validation. The training discussed key CSA concepts like critical thinking and risk management.

The workshop’s focus was to help the company devise an action plan and quality metrics to transition from the traditional approach of software validation to incorporate critical thinking to eliminate non-value added, burdensome validation activities.

Following the delivery of the CSA/CSV workshops, SeerPharma was asked to deliver a second set of training programs on 21 CFR Part 11. This program covered:

• Purpose, scope and history of 21 CFR Part 11
• Key definitions in 21 CFR Part 11
• Implications for computerised system in applying 21 CFR Part 11
• Achieving Compliant Systems
• Applying 21 CFR Pt 11 to new & existing systems
• Reviewing Example Scenarios

SeerPharma has extensive experience assisting firms with Computer Software Validation/Assurance issues, with a seasoned team of QA IT Professionals in its ranks. Our team of CSV experts can help you and make sure that your approach is compliant with relevant regulatory guidelines from the FDA and PIC/S.

Contact us to discuss how we can assist with your GxP-IT needs.