Kneat Manufacturing

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 the all the management documentation functionality of traditional MES solutions in a simple affordable FDA compliant system.

The Kneat platform allows companies to build their solutions around the business 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.

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.

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.

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

Benefits & Features

Accountability is a critical component of quality management and regulatory compliance. Production records, required by FDA regulations, demonstrate accountability and provide proof of proper handling for every step in the production process.

Establish greater global operational consistency, centralize best practices, reduce errors, and ultimately drive significant cost savings

Flexible Paperless Solution

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.

Some of our key features include:

• 100% paperless
• 100% configurable
• Simple business process modelling functionality
• Master batch/lot record management
• Easily configured workflows
• Collaboration in real time
• 21 CFR Part 11 and Annex 11 ready

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

Some of the key benefits include:

Quantifiable Benefits

Reduced Cycle Time	All manufacturing records are stored in one secure location allowing for rapid access from anywhere with fast review and approval cycles.
Improved accuracy & consistency of the batch records	The correct versions of all batch records and associated documentation are never in doubt
Reduction of paper work from the shop floor	Kneat Manufacturing stores all records in one central secure database
Reduced cost of compliance	Significant reduction of errors associated with traditional paper based systems
Increased productivity	Operators can focus solely on batch production and not the paper work over head
Increased speed of product introductions and process changes	Unlike bloated MES applications Kneat is easy to configure and make changes when required
Access of documents in speciality areas: Biotech Aseptic Fill finish Medical Devices Sterile Implants Baby food Eye care products Cytotoxic	It makes industrial professionals to access these documented instructions on smart screens in Sterile/Aseptic/Controlled environments thus reducing the usage of paper in these areas thus reducing potential source of contamination risk and also operations like sterilizing such papers. This not only reduces time but also cost to companies.

Solution Benefits

Elimination of all paper work from the shop floor	Kneat easily replaces all traditional paper processes
100% audit trailed	Who did what and when, all transactions are fully traceable
No process mapping required	Why re-engineer existing processes that work, Kneat makes it possible to directly map your production processes
Real time reporting	Our model based architecture ensures total visibility throughout the batch manufacturing process
Significant deviation reductions	Traditional paper related deviations are irradiated
Audit ready	Significantly reduces both internal and external audit prep time, as all manufacturing records can be found in one secure location and accessed from a browser anywhere
Enables process focussed manufacturing	Operators can now focus on batch production and not worry about the extensive management of paperwork
Can’t lose documents or data	No more time wasted looking for important documents and records that go missing at crucial times
Reduce QA/QC review time	A collaborative review process ensues quicker turn-around of product
Prevent anti-counterfeit measures and serialisation	Unique batch information is always standard throughout all related batch documentation
Maintain and competitive advantage	Removing slow traditional paper based production offers a unique competitive advantage

A Structured Approach to Electronic Batch Records

Kneat Manufacturing is particularly suited to companies who want a flexible paperless manufacturing environment which can accommodate many complex manufacturing records or MBR variants but do not want the cost and disruption associated with a complex MES.

Kneat.NET

The Kneat.net platform, allows companies to easily automate these existing processes in a cost effective and practical manner. “Electronic Batch Record Management” (EBR) and “Paper-on-Glass” are other common terms for electronic control and collection of all of this Batch/Job data and control information.

Instantiated from One Location

The master batch records and all associated records can be instantiated from one secure location, ensuring the correct records are always used.

From bill of materials to inventory control to QC Inspection, the correct records are always used for the manufacturing batches being manufactured.

With one version of the truth at all times anyone associated with the manufacturing process can concentrate on the manufacturing process.

Populate Records

As production progresses all stakeholders (Production, Laboratory, Warehouse, EHS, QC etc.) can enter their respective data into the live records and sign for it electronically. Supporting attachments in any format (pdf, word, excel etc.) such as a sample label can be attached electronically as part of the record.

Observations & Deviations

Observations or deviations can be created for further automatic processing according to your procedures. No problem if an observation results in an operator having to change a recorded value, the old value will receive a strike through and his signature will be captured again with the new recorded value.

View in Real Time

As production continues anyone with the correct privilege can view the data being entered in real time on their browser and from any place in the organization allowing total visibility.

Review & Approve

If required your quality person can review the electronic batch record at any time and sign-off to confirm that all is well at that particular stage. When production is complete all the records including the observations are available centrally for review, approval, closeout and release.

Challenges

The Paper Trail Problem

Companies have evolved process solutions to suit their particular business models over the years; a large paper trail of documentation will follow every work order or production job through the factory. This paper trail might typically include Inspection sheets, Set-up Sheets, Material Usage Forms, Specification Sheets and many more.

Therefore, while the overall business strategies and methodologies can be considered world class, the day-to-day business operations are often still stuck in the dark ages, swamped in paperwork, spreadsheets and pencils.

	Traditional Paper Problems	Our Solution
Production	Operators use incorrect versions of paper work instructions leading to confusion and rework.	One version of the truth is communicated instantly to the shop floor ensuring accurate information at all times.
Shop Floor Visibility	Supervisors and Management do not know the status of batches until the ERP system is updated.	Read only access to batch records allows visibility in real time.
Quality	Paper-driven NC/CAPA process creates a backlog of orders waiting for inspection or completion of an MRB process.	Quality is included as part of the production process eliminating laborious paper driven processes. Quality engineers are able to measure, direct and report on quality activities as they happen.
Document Control	Employees spend hours copying and collating paper work instructions for the shop floor often resulting in delayed production.	Employees have information available on demand ensuring accuracy and on-time delivery.
Document Control	Employees spend time tracking compliance standards or government regulations and chasing paper for as-built records and audit reports.	All interactions with the system are time, date and user stamped creating a complete audit trail. Electronic as-built records make manufacturers audit ready 24/7.

Ineffective Process

Paper-based systems are often used in regulated industries to manually record all the actions performed by operators and support staff during production of a drug product or medical device and each record is signed accordingly. These paper-based systems are difficult to administer, enforce and extremely time consuming to verify during batch/lot approval and release processes.

Production operations conducted manually are inherently slow, cumbersome, and error-prone. As regulations get more complicated, batch and lot history records become exponentially larger and more complex, taking more time to prepare and review.

US cGMPS

Subpart J — Records and Reports
Sec. 211.188 Batch production and control records

Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. These records shall include:

(a) An accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed;
(b) Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including:
(1) Dates;
(2) Identity of individual major equipment and lines used;
(3) Specific identification of each batch of component or in-process material used;
(4) Weights and measures of components used in the course of processing;
(5) In-process and laboratory control results;
(6) Inspection of the packaging and labeling area before and after use;
(7) A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing;
(8) Complete labeling control records, including specimens or copies of all labeling used;
(9) Description of drug product containers and closures;
(10) Any sampling performed;
(11) Identification of the persons performing and directly supervising or checking each significant step in the operation;
(12) Any investigation made according to Sec. 211.192.
(13) Results of examinations made in accordance with Sec. 211.134.

EC GMP Guide

Chapter 4 Documentation
Chapter 4 Documentation

4.17 A Batch Processing Record should be kept for each batch processed. It should be based on the relevant parts of the currently approved Manufacturing Formula and Processing Instructions. The method of preparation record should carry the number of the batch being manufactured.

Before any processing begins, there should be recorded checks that the equipment and work station are clear of previous products, documents or materials not required for the planned process, and that equipment is clean and suitable for use.

During processing, the following information should be recorded at the time each action is taken and, after completion, the record should be dated and signed in agreement by the person responsible for the processing operations:

(a) the name of the product;
(b) dates and times of commencement, of significant intermediate stages and of completion of production;
(c) name of the person responsible for each stage of production;
(d) initials of the operator of different significant steps of production and,
where appropriate, of the person who checked each of these operations (e.g., weighing);
(e) the batch number and/or analytical control number as well as the quantities of each starting material actually weighed (including the batch number and amount of any recovered or reprocessed material added);
(f) any relevant processing operation or event and major equipment used;
(g) a record of the in-process controls and the initials of the person(s) carrying them out,
and the results obtained;
(h) the product yield obtained at different and pertinent stages of manufacture;
(i) notes on special problems including details, with signed authorization for any deviation from the manufacturing formula and processing instructions.

Paperless Manufacturing - Brochure

If you would like to learn more about our product please click here to the download our Paperless Manufacturing Brochure.

If you would like to contact us directly about our Paperless Manufacturing Solutions please use the contact details below.

Email: inquiry@kneat.com
Phone: +353 61 203826

Paperless Manufacturing - Power-point

If you would like to learn more about our product please click here to the download our Paperless Manufacturing Power-point.

If you would like to contact us directly about our Paperless Manufacturing Solutions please use the contact details below.

Email: inquiry@kneat.com
Phone: +353 61 203826