Consultancy for Pharmaceutical Sector
Aurum-Data is an expert on Quality Management Systems in the pharmaceutical industry. Through our unique approach to combining Quality Consultancy and Quality Management Systems, which are CFR part 21 compliant, we ensure GMP compliance and reduction in deviations, errors and ultimately cost. We comply with the quality standards set by the FDA and follow the best Data Management practices for Pharmaceutical Organization based on ALCOA principles.
Our pharmaceutical consultants offer practical knowledge and experience in implementing or enhancing your Pharmaceutical Quality Systems (PQS) to meet GMP code requirements and those based on ICH Q10/ISO 9001:2015 for Pharmaceuticals. GMP Audits – We assist our clients with GCP, GLP and GMP gap audits/assessments/remediation plans to help you prepare for regulatory audits and inspections from agencies such as TGA/MHRA/US FDA.
We provide the following services to our clients:
Process validation– We offer pharmaceutical process validation that complies with US FDA, PIC/S, and EU EMA regulations.
Equipment validation– We validate whether your equipment complies with the pharmaceutical and international regulatory standards in accordance with current best manufacturing practices.
Cleaning validation – We validate the cleaning protocols for your pharmaceutical and medical device manufacturing facilities.
Computer systems validation– We validate whether your computer systems comply with the TGA, US FDA 21 CFR Part 11 EU, and PIC/S PE 009 Annex 11 regulations.