Biomedical Engineering Reference
In-Depth Information
21 CFR 820.70
(g) Each manufacturer
shall ensure that all
equipment used in the
manufacturing process
meets specifi ed
requirements and is
appropriately designed,
constructed, placed,
and installed to facilitate
maintenance,
adjustment, cleaning,
and use
(1) Maintenance
activities, including the
date and individual(s)
performing the
maintenance activities,
shall be documented
(fi rst predicate rule) also stipulates that the cleaning and
maintenance must be recorded (second predicate rule).
16
The form of these typical regulations involves two aspects:
a requirement (one predicate rule) that a task or activity be
proceduralized and the SOP be followed, and a requirement
(a second predicate rule) that an associated record be kept of
the activity or task. The second predicate rule, dealing with
record-keeping, implicates Part 11 if the organization had
decided to manage the record electronically. Insofar as Part
11 is implicated, procedures and controls must ensure the
authenticity and integrity of electronic records. Moreover,
procedures and controls must hold individuals accountable
and responsible for actions initiated under their signatures.
11.3.1 Training records
By contrast, the documentation of training, including
training records and training assessments, is not covered by
such predicate rules. FDA regulations for areas such as
pharmaceutical and biopharmaceutical operations, clinical
trials, medical device operations, or human tissue processors
require that personnel be trained.
17
These are examples of
the fi rst predicate rule noted in Table 11.1.
