We assist with ERP Project approach in Validation regulated industries such as Pharmaceutical, Medical Devices, Nutraceuticals and Chemicals. We can assist in consulting related to GMP relevant inputs, data records and outputs like Package Labels containing Batch or Lot Numbers, Serial Numbers, expiry information, validation of electronic (EDI, XML and other) transactions exchanged with trade partners.
Did you know that the way you approach your project and installations from the onset, already has an important influence on the cost and effort to have a Validated Computer System?
*Do you have Record Keeping on labels produced previously?
*Have you challenged your labeling process to make sure you obtain the required outputs consistently?
*Would label information be important for the purpose of tracking your product through international distribution channels and influence possible product recall decisions?
*Do you need to follow Good Distribution Practices and Good Warehousing Practices?
To achieve validation you need to ensure your data records are Attributable, Legible, Contemporaneous, Original, Accurate, Consistent, Complete, Available.
We can provide consultation services to assist you with your responsibility of achieving Qualification and Computer System Validation of your hardware and Software solutions based on GAMP5 practices according to FDA 21 CFR part 11 cGMP and EMA EU GMP EudraLex Annex11.
We can help you methodically establish risk, gapfit, project plans and achieve documented proof of validation.
Methodology! GAMP®5 stands for Good Automated Manufacturing Practice and is based on input from pharmaceutical industry professionals. GAMP®5 provides us with an excellent tool to ensure your business meets regulatory compliance.