This graphic depicts a city skyline where validation staff evaluation documentation is in use.

Validation Staff Evaluation Rationale.

Validation staff evaluations are carried out routinely to enable managers to recognise which staff are worthy of incremental salary increases and or promotions and which ones are not. These evaluations are normally divided into several sections or rather several attributes that the company values in an employee. For instance the military use a compact simple system comprising of three sections, namely; technical ability, organisation ability and personal deportment. The latter two attributes can usually be judged by any competent manager. The technical ability attribute often cannot be so accurately assessed since it is routinely the case that the manager’s skill set is radically different from the person (s)he is appraising.

This problem is also very apparent when recruiters are trying to establish an interview list from a bunch of CV’s. Just how factual is curriculum vitae content? Pressures drive people to overstate facts and at times to add embellishments. If you have thirty applications are you going to interview all thirty? How are you going to probe the depth and scope of their validation skills? How are you going to establish a shortlist that does not overlook a potential star? Often this list is produced using intuition and a little guess work.

So, what is the answer to this conundrum? Well our take on this is to produce multiple choice test papers that contains 100 or alternatively 50 questions designed to probe the candidate’s knowledge of cGMP validation. These test papers are derived from a question bank of over three thousand multi-choice questions stored in six sections (aspects of validation). The software design ensures that a predetermined number of questions are selected randomly from each of these sections.

These question papers are available from our shop. On completing the purchase forms the question papers will be sent out to the proposed candidate’s email address, at a date and time you have specified. The test has a time limit for each question and a total time limit of one hour for the 100 question paper and 35 minutes for the 50 question paper. The results are sent direct to the purchaser within minutes of the candidate’s examination being completed.

The Rationale for Using Multi-choice tests.

The use of an independently constructed multi-choice question paper is a spectacularly simple method of reducing your list of applicant’s, from a large unwieldy number of aspiring hopefuls, to a short manageable list of persons whose test results show to be technically fit for purpose. The interviewer can then concentrate on appraising the interviewee’s attitudes and attributes. This is a task that is usually well within the capabilities of most managers or supervisors.

These same line managers and supervisors are tasked with a similar problem of assessing their staff; usually annually. Since they work with them appraisal of attributes and attitudes should be relatively straight forward. However in validation just how competent are they? Are they leaching off others? Are they taking personal credit for other person’s initiatives?

So many of these problems lie dormant; never asked and never answered. They eventually cause ill feeling and develop friction between staff members. The use of a standard test for all staff is a uniform, justifiable and fair way of assessing individual validation abilities.

The mechanics of these tests.

The test papers are derived automatically from a data bank over a thousand questions (this is continually expanding). The software allows the arrangement of the answer choices to be randomly arranged along with randomly selecting a pre-set number of questions from each of seven sections. Having made the selection this same selection can be issued to multiple candidates. This ensures that the test is uniform and fair to all participants.


Question data banks quickly become eroded if questions are allowed to be plagiarised from it. For this reason we do not leave our question papers with anyone. The candidate will receive a multi-choice paper to an email address of their choice. They will have the allotted time to complete the paper then the paper will close down and the results will be emailed to the purchaser of the test paper. The candidate will require all this ‘paper open’ time to answer the questions. This will go a long way to preventing plagiarism and data bank erosion.


SOP for Spreadsheet Creation.

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.

SOP for Spreadsheet Creation. -- $125.00


SOP Equipment Validation.

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

Purchase your copy now at Special Price of $22.00.


Validation Risk Assessment (Issue11.) -- $125.00

The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).


Equipment combined IQ/OQ/PQ Protocol.

This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.