Part 11 latest guidance

It now appears that the current FDA Guidance rules pertaining to 21 CFR Part 11 may be with us for a longer time than was originally anticipated.  So we have incorporated the guidance suggestions in this guidance document, into our current Validation Risk Assessment (now issue 10), which is now available for immediate download.

Part 11 will be interpreted narrowly; we are now clarifying that fewer records will be considered subject to part 11.

This would appear to mean that the original all embracing approach to all electronic records is to be dropped and the rigors of part 11 applied only to the data that directly affects product 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, and record copying.

This would appear to mean that if your in-house document control is secure and robust; then it will be acceptable in the matter of audit trail / record retention and record copying. 

We will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements.

This is 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 plan to rely on the electronic record or paper record to perform regulated activities. We recommend that you document this decision (e.g., in a Standard Operating Procedure (SOP), or specification document).

This is a new requirement for a database of predicate (all) data records, giving a documented 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.

New Interpretation:

A predicate data record does not require to be Part 11 compliant; unless it is the master copy of the predicate data and is stored in an electronic format. 

I.E. if the record is derived from an electronic source and is downloaded into a hard copy format; which then becomes your master copy of the record; then this paper copy is not subject to Part 11 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.

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Calibration of Humidity & Hygrometer Sensors.

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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.
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The SOP for Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
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