We are trained as lead auditors (FDA/IMB and ISO) and have extensive experience with clients in both pharmaceutical and medical device companies. Good Auditing Practices are applied throughout the preparation, execution and reporting of all our audits. Give us a call today to discuss your need. We are always willing to discuss needs with prospective or existing clients and share our perspective without charge.
Supplier Auditing
We perform both initial qualification audits to approve a new supplier and on-going audits to meet the requirements of your supplier management programme. In addition, investigative audits following process concerns are also undertaken.
API Auditing
Compliance to ICH Q7A (now incorporated into EU Volume 4 GMP guide) is assessed.
Pharmaceutical Finished Products
Compliance to either or both EU (IMB) and FDA regulations is assessed. Audit reports and the classification of observations are done according to regulatory guidelines aligned to the client requirements.
Healthcare - Medical Devices
Compliance to ISO 13485, FDA and EU regulations are provided as appropriate to the classification of your device(s) or of combination products.
New Suppliers to Pharmaceutical and Healthcare
We have experience of clients (Suppliers) requiring support to develop their quality systems and understand regulatory requirements as part of their entry plan to supply the pharmaceutical and healthcare industry.
Computer Validation Software Provider Audits
We have experience of auditing the providers of configured software as part of a lifecycle approach to the validation of computer systems and the leveraging of testing done by the provider to augment the validation for intended use.
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