DENTAL VALIDATION
Dental Validation web page.
Dental Validation requires that all dental practices, workshops and manufacturers are compliant with the sections in 21 CFR Part 820 applicable to their activities. A trawl through current FDA Warning Letters however shows wide spread transgressions; many quite petty and simple to negate, others rather more serious and requiring a speedy in depth response.
It is imperative that companies which are in default respond to a regulatory default as soon as possible. Often it is not possible to immediately rectify all aspects of the default(s) – but it should be possible to design a concise defined remedial plan of action and present it to your regulators. After that it is paramount that the remedial plan; time lines and key-point dates are achieved and progress published. Such actions will give your auditors confidence that they can work with you rather than having to resort to citations.
Validation Online have produced a full complement of validation documents for dental facilities to use. Starting with the Validation Master Plan (VMP) continuing through the Validation Plan (VP) and on through the User Requirements Specification (URS) to the Validation Risk Assessment (VRA) and ending with the Design Qualification (DQ).
For the Installation, Operational and Performance Qualification protocols, we have opted to use a single combined IQ/OQ/PQ protocol. This document can easily be edited up or down in size and can be copied over as many times as is required.
Mandated Staff Positions.
This will be the individual with ultimate responsibility for decontamination equipment ownership and the definition and appointment of the following staff. In a dental practice, this could be the health service contractor, practice owner or a person of similar authority.
Decontamination Lead:
The Code of Practice makes it a requirement that an individual is given the responsibility for infection control and decontamination. This person should have the experience and authority to perform this task and should be accountable to the Registered Manager.
Designated Person:
This role acts as the interface between the practice and support services supplied externally, including service, maintenance and testing. This could be the general manager of the practice. The Decontamination Lead could also act as the Designated Person.
Authorizing Engineer (Decontamination):
This is an external role that provides guidance and advice on the compliance issues of decontamination, including the implementation of this Health Technical Memorandum and associated guidance documentation. A list of suitable persons is available from the voluntary register held by the Institute of Healthcare Engineering and Estate Management (IHEEM) (http://www.iheem.org.uk/Technical-Platforms).
Authorized Person (Decontamination):
The Authorized Person provides technical support to the Competent Person and liaises with the Authorizing Engineer. The Authorized Person may be directly employed by the practice or provided by a third party.
Competent Person (Decontamination):
The Competent Person is responsible for the servicing, testing and maintaining of the decontamination equipment within the practice. The Competent Person may be directly employed by the practice or provided by a third party.Competent Person (Pressure Systems):
Validation Risk Assessment (Issue 11) $125.00
Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online 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 Risk Mitigation in Validation template.
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).
Combined IQ-OQ-PQ Computer (Issue-4) $159.00
This Pharmaceutical Validation 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 and associated standard operating procedure TEMPLATE. The associated medical device validation Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.
The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; The User Requirements Specification template
Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020
The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (IQ), takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification template. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template.
Operational Qualification, SOP & Protocol (Issue 10.) $115.00
You will find this validation online intuitive Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.
Dental_Validation Package $695.00
The DVP contains all the regulatory mandated documents. The hyperlinks and cross references between them make the package; not only unique, but also highly cost effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are presented formally. All the documents are written in MS word, to facilitate simple editing of text, layout, tables and schematics.
10002001. Validation Master Plan: (VMP). $115.00.
The VMP must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview, to a reviewer, of how the company has integrated all applicable cGMP requirements into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks.
10002004 Validation Plan: (VP). $115.00.
The VP must specify methodologies, assign staff, designate responsibilities and give specific guidance on any contentious or ambiguous aspects of the VP validation task. Where it makes commercial sense and is compliant with cGMP rules and regulations; each VP can be written to cover multiple items.
10002008 User Requirements Specification: (URS). $115.00.
The URS is produced once the product is established. With the product concept documented – then the design / recipe can be further analysed. From these investigations the requirements for facilities, utilities, maintenance, calibration, operator skills, software, documented specifications and engineering drawings can all be extracted and provisioned for.
100042010 Validation Risk Assessment: (VRA) $125.00.
Risk Based Validation was introduced to apply a level of validation that was adequate to maintain confidence in the qualification process; but would reduce unnecessary repetitive testing. The Validation Risk Assessment (VRA) was therefore designed to ensure that this level of validation is consistently used.
10002016 Design Qualification: (DQ) $115.00.
With a company approved VP and URS produced; vendors can be invited to submit submissions. These submissions will be challenged by the execution of a DQ; which will or will not certify that the vendor’s submission; if proceeded with, will fully satisfy all the requirements listed in the URS.
10002021 Combined Protocol: IQ-OQ-PQ. $169.00.
The Installation Qualification (IQ) section shall include test scripts that when executed shall verify that each testable requirement applicable to installation is fully complied with. The Operational Qualification (OQ) section shall include test scripts that when executed shall verify that each testable requirement applicable to Operation is fully complied with. The Performance Qualification (PQ) section shall include test scripts that when executed shall verify that each testable requirement applicable to performance is fully complied with.