Regulatory Compliance – Pharma

FDA 21 CFR 11 & EU GMP Annex 11

All topics around being compliant for the pharmaceutical industry and their suppliers have one obligation in common: all data and documents in the IT infrastructure have to be managed with a clearly defined workflow, must be protected against manipulation and have to long-term storable. The main focus of IT compliance is the audit-proof data and records management at all levels.

It takes account to the fact that the risk of counterfeits, misinterpretations and not verifiable changes is much higher regarding electronic data than if using paper based documentation and signatures. A specific manufacturing process, which is subject to approval, gets validated in accordance to 21CFR Part11.

In Europe the EMA (European Medicines Agency) gives or withdraws the authorization for a pharmaceutical product or genetically engineered preparations.

Every IT system, which is involved in the production process of pharmaceutical preparations for the USA, must be validated and in line with the FDA / GMP guidelines. Our service portfolio includes all technical and documentary preparations for your upcoming audits.

What we offer:

  • validation and qualification of computerized systems
  • access protection and audit trail
  • storage and protection of collected data
  • reproducibility and provision of data
  • electronic signature (eSig’s)
  • document management
  • audit preparation and support
  • applications for electronic submission

Get in touch today, we're happy to help!

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