Paperless Manufacturing – The Easy to Implement Cost Effective Way!

All your records in one secure location

Flexible Approach

Kneat Manufacturing™ is the most flexible approach to paperless manufacturing yet. It delivers a large proportion of MES benefits with almost no disruption and for a fraction of the cost.

Kneat Manufacturing has all of the management documentation functionality required for regulated manufacturing in a simple affordable FDA compliant system.

The Kneat platform allows companies to build solutions around their business processes by using our 100% configurable software.

Simplify
Kneat Manufacturing has been designed to simplify the documentation processes associated with manufacturing and batch production.

Natural Alternative
Kneat is a natural alternative for manufacturing companies who are using MS Word and Excel generated paper documents to record elements of their manufacturing processes.

One Version of the Truth
A key feature of Kneat is not only can the batch or device history record be automatically generated on creation of the batch or lot number, but all associated forms from bill of materials, inventory requests, specifications, QC inspections, etc, can also be created at the same time so that they are available and easily accessed by operations personnel when required.

Instantiate All Related Batch Records
Once a new batch number is created in the Batch Number Assignment Form, the master manufacturing records are instantiated and all associated records for that batch are generated in one secure location

Full Visibility
Removing the paper and putting your production process online means that management can now have full visibility on the progress of all production lots in real time without having to enter the production environment.

Non Conformances
Non-conformances can be flagged and dealt with in real time, reducing delays and improving the use of resources.

No More Paper Chasing
Electronic work flow processes mean that the approval of a batch for release is now a collaborative process, gone are the days of chasing paper. Retrieval of critical records is only a button click away.

No Customisations
Customizations create a legacy problem when upgrading to newer system versions, because at least a part of the customizations will have to be re-implemented in the new version, creating cost in terms of development, testing, and re-validation.
Kneat’s .NET platform is 100% configurable ensuring no custom code or bespoke development is required

Part 11 & Annex 11 Ready
The Kneat.net platform conforms to compliance standards such as FDA’s 21 CFR part 11 (for electronic records and signatures) and EU’s Annex 11. Users of the Kneat Gx application can rest assured that their data is fully protected according to the regulatory requirements.

Contact Details

Kneat Solutions
National Technological Park
Limerick
Ireland

Website: www.kneat.com
Phone: +353 61 203826
General Inquiries: inquiry@kneat.com

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An Alternative View of the ICH Q10 Pharmaceutical Quality System (PQS)

The image below is that depicted by the International Conference of Harmonisation (ICH) Q10, Annex 2, and is supposed to depict a PQS or Pharmaceutical Quality System.

Typically, I really love the ICH. When we have to deal with outdated regulations from different global organizations it becomes a real nightmare trying to keep track of the nuances and the ICH has done a pretty good job of bringing several of the key organizations together and aligning them on how best to organize and meet the expected requirements.

That being said the diagram below and the depiction in Q10 of what a PQS should look like is greatly lacking.

Development Phases

In section 1.8 under the Quality Manual the ICH Q10 guidance states, “The description of the PQS should include: …(c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages and interdependencies.

Process maps and flow charts can be useful tools to facilitate depicting the pharmaceutical quality system processes in a visual manner”.

I completely agree.

The problem is using the graphical depiction they present in Annex 2 is completely worthless.

Basically they listed some of the PQS elements in a bar and then said they all apply to the entire product lifecycle, which simply isn’t true.

When we are in the development phase of our product lifecycle why would we do that under the change management system, or monitor process performance?

 

Controlling Change – No Value Add

There is no point in controlling changes for a product that is purposely being changed, nor does it offer any value to monitor the process performance for a process that has yet to be developed.

This isn’t a graphic depiction of the PQS, but rather a graphic of how they depict the lifecycle management (which also has some issues).

The PQS is the quality system and its subsystems and how they interrelate.

While it’s useful to look at how the PQS and product Lifecycle Management overlap and what elements of the PQS system are relevant at each lifecycle stage, it is not the point of the PQS, and even if that’s the end goal it’s not depicted here at all.

This image offers almost no value.

A Better Approach

So, what should this graphic look like?

While this is not a perfect view of a PQS, I would propose that the image below is a much better depiction of how the PQS should be visualized and a good place to start.

At the core of any quality system should be management. This goes back to Deming, who said, “Quality begins with the intent that is fixed by Management”.

Quality has to be rooted in the executive management team.

Define Core Quality Systems

Core quality systems then need to be defined. These are systems that impact all aspects of the business and include a Risk Management Policy, Resource Management, Document Control and CAPA systems.

All of the other subsystems, Deviations, Supplier Management, Equipment Qualifications, Validation, Material Management, etc, etc. all should be risk based or involve risk assessment, they all require resources and training, they call require documents (procedures, policies, records), and the CAPA system of course drives for process improvement regardless of the process.

Subsystems

All subsystems feed back into the main Management module. The subsystems listed, all are interconnected, with the exception of Post Market Systems.

The subsystems are important too, but they are farmed out to different groups and have different levels of importance depending on the stage of the product lifecycle.

Post Market Systems

The one exception is the Post Market Systems. This includes complaint management, product reviews, recall processes and other systems to support marketed products.

These generally do not interact with the other subsystems unless it is through the CAPA system or other management functions, but still utilizes all the systems under the management umbrella.

Alternate View

The PQS presented here, isn’t intended to be perfect, but I thought it was worth presenting an alternate view to the one presented by the ICH.

The ICH concept is a good one, and the ideas are fairly well laid out in the ICH, but the graphical representation of the PQS leaves a lot to be desired.

When establishing a PQS, it is better to start with something to what we’ve depicted here, and customize it as needed for the organization.

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How 21 CFR Part 11.3(7) Applies to Electronic Batch Records [Video]

When dealing with Part 11 it’s important to understand what an electronic signature actually means

The definition of electronic signatures or e-sigs can be found in 21 CFR Part 11.3(7).

Electronic Signature

An electronic signature or e-sig means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

Handwritten Signatures

We also need to understand what a handwritten signature means in the context of Part 11.
The definition of handwritten signatures can be found in 21 CFR Part 11.3(8).

Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form.

The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.

Electronic Batch Records

Eric works in a Pharmaceutical company and he is responsible for the filling process of the batch been manufactured.

Each time Eric performs the filling process he has to populate a batch record with the appropriate details

After each step Eric must also fill in his signature and date to verify that he actually performed each task.

Eric is manually handwriting these details and they are legally binding to Eric.

21 CFR Part 11.3(8)

This is when 21 CFR Part 11.3(8) applies.

Fast forward 12 months and Eric’s company has implemented a brand new Manufacturing Execution System (MES) where all details around the batch manufacturing process are recorded electronically.

21 CFR Part 11.3(7)

Now when Eric performs the filling process he now populates everything electronically and signs with his username and password combination to verify that he has performed those tasks.

This is when 21 CFR Part 11.3 (7) applies.

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