Computer system validation as per 21 cfr part 11
Posted: Wed Aug 05, 2015 12:37 pm
by saikorem
Dear All,
Please suggest or provide protocol for computer system validation as per 21 cfr part 11 and what are the things look into it when performing validation.
Re: Computer system validation as per 21 cfr part 11
Posted: Wed Aug 05, 2015 1:20 pm
by tjbr
It's mainly about the maintaining the integrity of any raw data generated, having sufficient controls to prevent manipulation/deletion of that data and having a completely transparent and auditable data chain. Prevention of data fraud in essence.
Each company is responsible for interpreting the FDA guidelines and applying those to their SOP's and equipment validation procedures. Where a company does not have the expertise in house they would usually hire a consultant to facilitate this. There is no single correct way to approach this, as long as the guidelines are adhered to.