FDA GMP Part 11 Downloadable Packages & Protocols.

This schematic is a graphic presentation of  FDA GMP PART 11 requirements.

Just what does FDA GMP PART 11 requirements apply to: It has become obvious to all persons who use any IT facility; that electronic data is extremely easy and simple to manipulate or corrupt, either knowingly or unknowingly. The regulation protects predicate rule information from such corruption, and is designed and enforced to give assurance of the integrity of all such data.

Validation protocols such as DQ, IQ, OQ, PQ, along with the associated VMP, URS, VRA, and VP can be prepared electronically, however they are completed by hand and are manually signed and reviewed, and as such; are not required to comply with FDA GMP Part 11 procedures.

Full Life Cycle validation (FLCV), including FDA GMP Part 11 requirements are portrayed visually in the diagram below. In this diagram the standard requirements are shown in BLUE boxes whereas the additional requirements for Full Life Cycle Validation (FLCV) are shown in ORANGE boxes. This layout is not definitive, and reasoned alternatives work just as well. The whole concept is that the software design must be planned, managed, and subjected to documented reviews throughout the entire design stage. All of this must be laid out in the QUALITY PLAN (QP), which must be a peer reviewed and company approved document. Without a QP being in place, it is almost impossible to achieve satisfactory FLCV. If these requirements are rigorously applied, it becomes impossible to achieve retrospectively, and inhibits the use of commercial off the shelf software (COTS). We know that some COTS software has, and is, used in a number of Product Quality Critical (PQC) software systems. The judgment whether a COTS system can or cannot be used is fraught.

On the 21st of October 2005 the US Federal Court decision against FDA in the Utah Medical case. Once and for all affirmed (among other things) that FDA may not adopt "industry standards" as "current" Good Manufacturing Practices (cGMP's) by fiat or Guidance. In order to be an action-able item, the any practice or procedure must be specifically mandated within CFR's.......Actual Court Case.

FDA GMP PART 11 Requirements and FLCV

This graphic is a schematic of the inter-relationships of validation documentation used for FDA GMP PART 11 Requirements qualification..

How do you adapt procedures and processes for www.21cfrpart11.com?

One of three approaches can be used by organizations to address the on-going FDA GMP PART 11 requirements regulations throughout the pharmaceutical and medical devices industries.

The full FDA GMP Part 11 regulation still permits the full submission of paper-based documentation. The issues with this approach include high costs, decreased quality, information storage availability, information retrieval ability, and the general portability of information.

Partial Electronic.

The regulation allows for the electronic records to be stored as equivalent to paper records with handmade signatures executed. This approach requires a large amount of printed documentation that carries the same risks and challenges as a full-paper approach; mentioned above, regarding complacency with the regulations

This is the real intent of the FDA GMP PART 11 requirements regulatory requirements. This approach increases product quality, saves money with automation of processes, establishes easy data storage and retrieval, provides ease data analysis and reporting, increases the portability of information, and diminishes or eliminates human error.

Defined FDA-21-CFR-Part-11-requirements.

This graphic represent weight of opinion for fda 21 CFR Part 11 requirements.

What content will be in the new FDA GMP PART 11 requirement? Most end users feel that it will be patterned after the ‘Scope and application’ document, though with more emphasis on ‘how’ compliance can be achieved, and less on ‘what’ requirements must be satisfied.

FDA will more than likely defer to the predicate rules on most matters. And it will make significant concessions on having an audit trail for all systems. “Likely, they will simply remove the section in the current FDA GMP PART 11 requirements requirements for the audit trail,”

At a minimum, manufacturers might have to have a risk matrix for their computer systems. This includes an understanding of how systems impact risk to patients, and regulatory risk.

The full requirements as detailed in the current FDA GMP PART 11 will more than likely still be a requirement for data produced by electronic manufacturing controls for high-risk systems — such as quality controls for the release or rejection of product. These will still require you to have to have a validated system and ensure an audible backup.

Define the criticality of each record and, even more important, look at the entire life of a record from its origin to archiving. Identify steps where adulteration is possible and make sure these systems have an electronic audit trail built in.

FDA GMP Part 11.

12000068 FAT_SAT_SOP

This combination document gives you basically 2 for 1 value. The Factory Acceptance Testing (FAT) and the Site Acceptance Testing (SAT) are very closely related. In the 'FAT' instance (which should be executed in the suppliers establishment), all aspects of design will be verified for compliance with the cGMP functionality specified in the URS. Completion and approval of the FAT, should allow shipment to point of use to be made. The SAT, must replicate the FAT plus all the additional test and inspections that are required to verify that all the 'installation specifications' as documented in the URS, have been fully satisfied. It is essential that the FAT is used to verify that all aspects of the performance Qualification template specified in the URS are working as specified, before the equipment is verified as ready for commissioning and then validation.

Combined IQ-OQ-PQ Equipment. (Issue-7) 

This three-part, cGMP compliant, protocol template will arrive with you: fully detailed, with all test scripts, rationales and test methods laid-out in accordance with regulatory expectations. First issued as an equipment-validation document; end-user demand quickly forced us into widening the scope of IQ-OQ-PQ (formated protolcols - click to view).

This combined IQ-OQ-PQ protocol along with the appropriate interrelated plans and assessment documents will not only validate the item under qualification, but it will also ensure that the detailed audit trail needed to meet all internal or external regulatory reviews and or inspections is produced.

Design Qualification (Issue 

The Standard Operating Procedure attached to this generic design Performance qualification Template, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained

Issue - 4. 

This Validation Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format.  Resulting in the document becoming notably easier to use and quicker to review and amend.  This new format will make a very significant difference to the man hours required to produce and execute these documents.  There will also be a very noticeable reduction in the time required for the reviewing and approving tasks.  This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document. 

Issue - 4. 

4Q Equipment Validation4u Protocol (4Q-Equip) has been designed specifically to replace four standard protocols.   By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining validation4u  documentation by reducing protocol numbers by close to 75%.  The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & Performance qualification template P1Q) and now compliments our equally new VrrP Protocol.  By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, it is still written in word and compliant with FDA GMP Part 11 legislation.

12000008 4Q Equip Package 

This quite unique two document package is all that is required to fully validate; to cGMP standards, equipment used in a regulated facility. A lot of effort has gone into ensuring that repetitive instructions and actions have been designed out and innovative and intuitive risk-based methodologies have been incorporated.
Both documents are prefaced with a methods' Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; 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 written in MS word, to facilitate simple editing of text, layout, tables and schematics and are compliant with FDA GMP Part 11 regulations.