The Creation of Electronic Documents: Paper on Glass & More

Whether or not your company has implemented an MES system, a huge number of paper records remain, even for the largest manufactures. Examples of these can be:

Batch Records
SOPs and Work instructions
e-Log books
Shift registers.
Metrology
Validation Documentation
Automated Regulatory Documentation

These records tend to either supplement the batch records or device history records. Alternatively, they can be used for other internal GMP purposes, e.g. training and shift handovers.

Here at LZ Lifescience, we are now providing a solution which can rapidly convert paper records into electronic PDF form templates. The templates can be stored within the system under version control,

instantiated with input field data for read-only fields, drop down box selection lists, tables, checklists, etc. Electronic PDF forms can also be nested to facilitate a hierarchical, scalable enterprise level solutions.

Rapid Document Conversion

Using optical character recognition (OCR) and familiar PDF technology, we can convert existing paper documents into their electronic template equivalent. They can be kept almost identical to the look and feel of the paper version to aid familiarity. They can also be easily modified to match customer preferences.

Minimum Configuration to Upload the Electronic Document

Once the electronic template has been created, uploading it into the system couldn’t be easier via automated transactions. This creates the necessary system structures to support the document.

Document and Form Fields

The documents and forms can range from simple data entry to advanced data capture. The following are fully supported:

Mandatory fields.
Data Validation Fields. Entered data can be checked against data limits, text validation, inputs from other fields, calculation components and much more.
Fields can be colour coded to indicate adherence to the validation rules.
A variety of selection fields such as pre-populated drop-down lists, tick boxes, radio buttons, etc.
Perform real time calculations in the form where the result can be displayed immediately so that actions can be taken.
Data can be used between forms. Data entered in one form can be used as an input to a calculation or validation in another form.
Autosaving, Partial Submission and Complete Submission

To ensure data is never lost, the autosave function will save the form data in real time. The functionality includes partial and/or fully complete forms.

All submitted forms are stored in the system database for data integrity and traceability purposes. Partially completed forms allow additional entries by default.

Fully completed forms will not allow additional entries editing.

Electronic Signatures

When a form is submitted, electronic signature(s) can be applied and stored as formal records.

Individual Form Completion

Uploaded form templates can be accessed and completed individually if required. Where lots of PDF form templates exist, filters facilitate the search for a type, category, department, location, etc.

Forms completed individually can still automatically be attached to a work order or batch.

Virtual Form Flow (VFF)

Where there is a required order of execution and completion of more than one form, the solution provides the ability to sequence forms ranging from simple sequences to complex and with different review and approval cycles.

Virtual Form Flow (VFF) can also work seamlessly with our standard workflow functionality. Batch or device history records can then be a combination of the data coming from the forms, as well as other standard transactions for inventory creation and consumption, form review, and approval routings, etc.

This is often referred to as a paper on glass solution in life science manufacturing.

External Data Source Population of Forms

As an extension of the standard Virtual Form Flow (VFF) functionality, the ShopFloor Online solution has the capability to interface with other document management systems, historians and data lakes.

Data from these sources can be landed and used to subsequently populate instantiated forms.

ShopFloor Online can also perform additional calculations, concatenations and/or data analytics prior to populating the PDF forms. This helps to standardise the data transfer.
There are no functional restrictions to what the forms could be used for, but some of the common applications would be:

Automated annual product reviews (APR).
Tech transfer documentation.
Metrology documentation.
Validation documentation.
Technical data sheets.
Product introductions.
Paper on glass batch records.
Assembly records.
Molding records.