This article discusses how documents work and is helpful for technical / regulatory administrators. If you want to know about Printing Documents see related help below.
Many different types of documents can be produced in Formpak, these include Safety Data Sheets, hazard labels and allergen declarations. In addition to the documents and labels supplied upon installation, other documents are available. It is possible to modify existing documents or design new custom documents.
Documents include information such as:
This information needs to be organised in a specific way in order it displays as required and to facilitate management of document supply, versioning and resupply. The core elements to the behaviour are specified in the Document Type, Document Design, Supply Conditions and Automatic Processing:
Document Type – This contains the key details about how the document is supplied, versioned and re-supplied. A critical part of automatic updates (versioning) of documents is the Versioning Properties and these are specified in the Document Type. The Document Type also captures which Document Design and Document Supply Condition are used. An example of a Document Supply condition can be phrased as send the Safety Data Sheet for all sales and all samples of items, and resupply new versions of the Safety Data Sheet if the sample supply or sale was made in the last 12 months.
The document type also contains a Permissions tab where you can specify which users are allowed to print the document.
Document Design – The design specifies the layout and basic behaviour of the document. It can include page / label size, format for header and footer, font sizes, which document content and properties appear in what position and under what conditions, specifies any ad hoc parameters. The document design is produced outside of the software in Jasper reports and imported into the software for use. Jasper-report is a free document designing package which can interact with a database.
Automatic Processing – Documents are routinely printed for customers or other parties. When record supply is ‘Yes’ the document printed is recorded in the system as having been supplied to the customer. Properties are regularly re-calculated (usually daily) and if a property value changes which is a versioning property, then this causes the document to get updated, i.e. the document is versioned. When documents get updated an automatic routine checks to see which customer received a prior version of the document, checks if the supply condition is met and flags documents to be re-supplied based on the results.
When documents are updated, the prior versions of documents are all still available.
Producing Documents and Record Supply
When a Document is produced in Formpak, e.g. by using Print a Document for an Item, a PDF is generated. The application stores a copy of this PDF against the relevant Item in the Document tab, as a generic Document (in English, no cross reference or customer name).
If a Document is intended for a customer, or another party, it is advisable to record this information as it enables use of the Document traceability features. For example, if a Safety Data Sheet for a formulation was required by the company ‘Big & Global Co.’, by entering the Company you can choose to record the supply of the document. In this case, the application stores the generic copy of the SDS plus registers the specific document against the company ‘Big & Global Co.’. This means all documents sent to a company can be electronically stored, retrieved and tracked.
The Formpak application uses Automatic Processing to make ongoing assessments of the status of Items and the potential impact on documents supplied. This means if there is a change to an Item, or the regulatory environment, which would impact a document such as a Safety Data Sheet or other document the application will flag that a new version of the document should be supplied. This process can be automated to a very large degree, so that a User only has to view Documents Required and resupply any outstanding documents.
It is also possible to link the supply of Documents to Suitability Checking. For example, it may be that a Company like the Big & Global Co. has particular requirements that must be met for all of its products. If a product, legislation or the company requirements change, it is possible that the product no longer meets the requirements of the company. By linking Suitability Checking with documents, Formpak ongoing assessments will also flag any Documents required for Items which may no longer meet the requirements of the Company. This enables the circumstances to be reviewed prior to submitting the documents.
It is possible to log Documents to any Party, e.g. customers, suppliers or the TO (your company). If your company has complex policies and it is difficult to maintain ongoing compliant status of products, supplying a custom document to yourself, the TO, combined with Suitability Checking will make this task a lot easier.