21 CFR Part11 Guidance Rules.
Part 11 latest guidance
now appears that the current
FDA Guidance rules pertaining to 21 CFR Part 11 may be with us for a
time than was originally anticipated. So
we have incorporated the guidance suggestions in this guidance
our current Validation Risk Assessment (now issue 10), which is now
for immediate download.
Part 11 will be interpreted narrowly; we are now
clarifying that fewer
records will be considered subject to part 11.
would appear to mean that the
original all embracing approach to all electronic records is to be
the rigors of part 11 applied only to the data that directly affects
quality and safety, and record (of the product) integrity.
For those records that are to remain the subject of
part 11, we will
apply discretion in the validation of audit trails, record retention,
This would appear to mean that if
in-house document control is secure and robust; then it will be
the matter of audit trail / record retention and record copying.
We will enforce all predicate rule requirements,
rule record and recordkeeping requirements.
a statement to the effect that
in all other ways 21 CFR Part 11 will be enforced.
Accordingly, we recommend that, for each record
required to be
maintained under predicate rules, you determine in advance whether you
rely on the electronic record or paper record to perform regulated
We recommend that you document this decision (e.g., in a Standard
Procedure (SOP), or specification document).
This is a new
requirement for a database of predicate (all) data records, giving a
and approved justification for the method of storage. Basically number:
1. It is not a predicate data.
2. It is predicate data, but does not
require to be stored in compliance with Part 11.
3. It is predicate data that must be
stored in compliance with current Part 11 requirements.
A predicate data record does not require to be Part
unless it is the master copy of the predicate data and is stored in an
the record is derived from an
electronic source and is downloaded into a hard copy format; which then
your master copy of the record; then this paper copy is not subject to
requirements; but must comply with all the other rules and regulations
governing the management of predicate data records.
Click here if you wish to read the whole guidance document.
Validation Risk Assessment (Issue10.) -- $125.00
This popular Validation Risk Assessment (VRA) has now been edited and enlarged to include Part 11 assessment tables for you to use in classifying which of your predicate records require to be stored in compliance with 21 Part 11, and which do not. It also includes an Excel spreadsheet to allow you to establish a permanent record of all such judgements, as is now mandated by the regulatory authorities.
Calibration of Humidity & Hygrometer Sensors.
Humidity sensors require frequent calibration and continual monitoring, they are, along with pH sensors, the most prone to error sensors in general facility use. They should be calibrated against a range of Chemical mixtures that establish a specified humidity calibration level in small atmospheric containers. These chemical mixtures are issued with UKAS traceable humidity calibration certification. They are supplied in a kit that includes three certified standards covering the low mid and high sectors of the relative humidity calibration percentage range.
The kit includes three ready to use enclosures (with certification of their values), a range of adaptors to suit your sensors, a sample FDA compliant calibration certificate and a complete detailed method statement on exactly what to do. All these items are contained in a robust neat and easy to handle carrying case.
To read more or purchase your test kit please click on link below.
Are you ready for an inspection?
With HEPA filters, the manufacturers recommended dirty filter change pressure differential (PD), is only correct if the filter is used at exactly the the same air flow as the makers specify. If there is any digression (there is often as much as 50% digression) then the makers PD must be corrected. If this is not carried out you can compromise the integrity of your room / machine pressure regimes. As you are no doubt aware this would be a very serious state to be in. There are also health and safety problems that can arise, if personnel are not getting the air flow protection that is sometimes designed into the system. This test script is not in the standard OQ, and is only available here as a download. Regulators ask to review your writen justification for these filter change PD's; make certain you have them.
Purchase your copy of this test script now at Special Price of $16.00.
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GO TO:- VALIDATION ONLINE DOCUMENT STORE