Automatic, mechanical, or electronic gear or other kinds of gear, including computer systems, or associated methods that can perform a perform satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. DQ should be sure that computer programs have all the necessary functions and efficiency standards that will allow them to be efficiently carried out for the intended application and to fulfill business requirements. Nevertheless, it is not advisable to easily writing up the seller's specifications because sometimes commercial software program has extra functions than the user ever will need. They're normally written by the developer of the system and should be reviewed by the person.
A backup file of data entered into the pc or associated system shall be maintained except where certain data, comparable to calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. Most detailed is the Industry Guide: General Principal of Software program Validation: (2).
Software usually contains working systems, commonplace purposes software and software written by of for a selected user. This primer gives an excellent overview and lists major Computer Software validation steps and duties however for an in depth understanding and for straightforward implementation readers are recommended to read additional references, for instance the SOPs and validation examples as included in the Pc System Validation Bundle from Labcompliance.