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ELECTRONIC RECORDS AND SIGNATURES

   Vulcanbury Ltd. provide strategic approaches and solutions to ensure existing legacy computer systems and new projects meet the FDA Electronic Records and Signature 21CFR Part11 requirements and EU Directive 1999/99/EU.

Clear interpretation on the key requirements of 21CFR Part11 and EU Directive 1999/99/EU enable technical and procedural solutions to be correctly applied.


Electronic Records and Signatures
  Vulcanbury clearly define GMP data integrity requirements and associated Signature controls that may apply where GMP sentencing is used.

Open and Closed Systems
  Vulcanbury clearly define the requirements associated with Open and Closed systems that need to be considered for GMP data systems.

Legacy System Evaluation
  Vulcanbury can evaluate existing legacy systems and provide effective remediation strategies to prepare organisations for regulatory inspections and manufacturing CSV auditors.

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