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.

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 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

Phone: +353 61 203826
General Inquiries:


Similar articles:

8 Essential Tips to Prevent Unauthorized System Access – 21 CFR Part 11 [Video]

Part 11 compliant systems must be designed so that unauthorized attempts to use e-signatures are detected and reported to security management.

Access must be limited to authorized individuals.

The FDA recommends the following.

1. Individual Account

Each user of the system has an individual account.

2. Data Entry Session

Users should log into their accounts at the beginning of a data entry session, input information (including changes) on the electronic record, and log out at the completion of the data entry session.

3. Limit Number of Logins

The system be designed to limit the number of log-in attempts and to record unauthorized access log-in attempts.

4. Unique User ID

Users should work only under their own user profiles encompassing unique user IDs and individual passwords or other access keys and not share these with others.

5. Admin Functionality

The system will not allow an individual to log into the system to provide another person access to the system.

6. Admin Functionality

Passwords or other access keys can be changed at established intervals commensurate with a documented risk assessment.

7. Log Off System

When leaving a workstation, users should log off the system. Alternatively, an automatic log off may be appropriate for long idle periods.

8. Automatic Screen Saver

For short periods of inactivity, an automatic protection (for example, an automatic screen saver) be installed against unauthorized data entry.

ELM-115: 21 CFR Part 11 – Electronic Signatures

Click here to learn more about our online course on 21 CFR Part 11 – Electronic Signatures Subpart c


Similar articles:

7 Top Tips for Validating Computer Systems in a Regulated Environment [Video]

The validation of any computer system in a regulated environment is always a tricky task with so many areas to cover. Not only do you have to ensure that the application adheres to 21 CFR Part 11 but it must also be validated to ensure that data integrity is not compromised throughout it’s life cycle.

To help you successfully validate a computer system remember the following:

1. Development Methodology

Select a development methodology that best suits the nature of the system – the risk analysis you do will help decide what level of validation is required.

For example, if you purchase the system from a third party vendor you may be able to leverage some of the testing they have already performed to streamline the effort.

2. Hardware

Select hardware based on capacity and functionality – vendors and IT personnel will guide this part of the process.

3. Opertional Limits

Identify operational limits to establish production procedures

4. Opertional Functions

Identify operational functions associated with the

  1. Users
  2. Processes
  3. Regulations
  4. Company standards
  5. safety requirements

5. Worst Case Scenrios

Identify and test worst-case production scenarios

6. Master Validation Plan

Clearly document the validation process and start by creating a master validation plan to define the effort involved

7. Written Procedures

Ensure the availability of written procedures to maintain the validated state of the computer system.

21 CFR Part 11 - Electronic Records

This video is taken from our online course on 21 CFR Part 11 – Electronic records. Click here to find out more about this course.



Similar articles: