21 CFR Part11 Guidance Rules.

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.

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.

GO TO:- VALIDATION ONLINE DOCUMENT STORE