Ensuring Compliance, Data Integrity & Regulatory Confidence
Pharmaceutical, medical device, clinical trial and other life science companies rely on IT systems and applications to manage critical operations. Regulators such as the US FDA, MHRA, and TGA require appropriate controls to ensure that data used for decision-making — especially those impacting product quality — is reliable and trustworthy.
SeerPharma provides expert support in ensuring compliance with:
- 21 CFR Part 11
- PIC/S Annex 11
- EU Annex 11
- GAMP 5
- ICH E6 (R3)
- IEC 62304 – Medical Device Software - Software Life Cycle Processes
- ISO 90003
- Data Integrity guidelines
- Audit Trail review requirements
Computerised System Validation (CSV) / Computer Software Assurance (CSA Support
Ensure your validation approach is risk-based, fit-for-purpose and meets regulatory requirements. We provide:
- CSV Master Plans (CSVMP): Strategy, oversight & execution
- Validation Plans: Project specific approach
- Framework Development & Review: Updating validation documentation for compliance
- Pragmatic Risk Assessment based approach
- Procedures, Forms, Templates & Guidelines: Writing and refining key validation documentation
- IT Infrastructure Qualification Plans: Development, review, and updates
- Software as a Service (SaaS) / Cloud Computing support
- Training and Mentoring
Gap Assessments & Audits
Stay inspection-ready with proactive assessments. Learn more about our independent gap assessments and audits that:
- Identify compliance gaps before regulators do
- Provide actionable recommendations
- Strengthen systems and operations ahead of audits and inspections
