Soft Computer Consultants 12/4/98 Blood Bank Computer SoftwareDESIGN CONTROLS
1) Failure to establish and maintain plans that describe or reference the design and development activities, and define responsibility for implementation including the plans that describe the interfaces with different groups that provide input to the design and development process [21 CFR 820.30(b)].
2) Failure to establish and maintain a Design History File (DHF) containing or. referencing records necessary to demonstrate that the design was developed in accordance with the approved design plan and the Design Control requirements [21 CFR 820.30(j)].
3) Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses including testing of production units under actual or simulated use conditions. Failure to document the results of the design validation in the DHR. For example, Softbank II application software, Release 1.21, dated 7/14/98 was not validated using the original protocol. [21 CFR 820.30(g)]
4) Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review and approve of design changes before their implementation. For example, quality assurance and approval of design changes did not occur before release and implementation of Softbank II software. [21 CFR 820.30(i)]
7) Failure to establish and maintain procedures to control all documents in that, obsolete and/or unapproved standard operating procedures (SOP) are referenced in approved SOPs [21 CFR 820.40]. For example:
a. SOP 1053A, entitled Softbank II Change Control, which is an approved procedure, references use of unapproved procedure, SOP 1012;
b. SOP 1078, entitled Configuration Management, which is an approved procedure, references use of unapproved and/or obsolete procedures, SOP 1081, SOP 1011, and SOP 1024B; and
