Pharmaceutical CDMO; electronic and paper GxP records
eQMS effectiveness review — pharmaceutical CDMO
The challenge, in operational terms
An electronic quality system had gone in quickly during the pandemic, driven by QA alone. Manual controls were still running alongside it and the people who'd built it had left the business.
What I did, including the assessment method
I ran a gap analysis against PIC/S data integrity guidance, mapped the processes, and delivered tailored QA training on what the assessment found.
What was delivered
The output was a short and long-term action plan.
The result
The client identified their compliance and data integrity gaps before a regulator did, re-planned resources and capital around replacing the system, and put remedial actions in place to hold the compliance position in the meantime.
Related services
GxP Compliance Assessments
An honest, prioritised picture of where you stand against the regulations that apply to you. Includes preparing for an inspection, addressing findings after one, and identifying areas for improvement.
For: companies who suspect something isn't right but can't name it or size it.
Data Integrity Assessments
Whether your GxP records would hold up to scrutiny. Paper, hybrid and electronic. Most integrity problems turn out to be workflow problems.
For: companies with documentation findings, or a laboratory environment they're unsure about.
Who you'd be working with.
I'm Antiksha Joshi. I've spent 28 years in pharmaceutical and life sciences quality across three continents. I am Chair of Women in Pharma, ISPE Australasia Affiliate.
I also write and speak on quality systems for various knowledge sharing organisations and online publications.
My background is in microbiology, and I hold a diploma in counselling, which sounds like an odd combination until you've watched a technically sound quality system fail because nobody could be persuaded to use it.
Whoever you speak to on the call is the person who does the work.
