"Complexity, volume and a high number of diverse users calls for built in power and bespoke design. Platina LS delivers enterprise level capabilities tailored for the Life Science industry." 

Platina LS is a fully integrated electronic quality management system (EQMS) that offers users complete control.

The enterprise level software ensures regulatory compliance across an organisation – from research and development to drug manufacturing and distribution. Developed specifically for Life Science organisations, it provides full support for meeting regulatory compliance with FDA Title 21 CFR Part 11 and EU Annex 11 requirements, including data security, data integrity, traceability/audit and electronic signatures. 


By using this powerful and flexible software solution it is possible to automate routine operations and improve efficiency on every level.

 

View screenshots of Platina LS by clicking the image below:

  • User workspace for a limited user of Platina LS system. The task area lists all active tasks for that user, both tasks originating from documents, Deviations, CAPA, CC or trainings in the same list. The symbols in each task are clickable and will ensure easy access direct to the object the task refers to. When the task has been executed it will automatically be removed from the list. The user in this case belongs to the function ‘Global manufacturing’. Folders listing all object owned by or related to ‘global manufacturing’ are available to the left. Eg If the user opens the SOP folder, she will easily find all effective SOPs in her function. All folders and documents are access controlled.
  • Platina LS has electronic signatures for approvals, training and administration of documents and cases. The different objects are signed directly from a fold out window in the task-list.
  • Predefined reports are easily accessible directly on the user’s startpage in Platina LS. Each report is access controlled.
  • Similar to reports, also advanced searches and initiation of new objects (eg new Deviation or new CAPA) in the system are easy to access directly from the user’s startpage. Each user can only initiate objects he / she have the right to.
  • By right clicking on an object anywhere in the system, the user will be given different alternatives on actions for that object.
  • Any object in the system (e.g. a document, a deviation, a CAPA, an Article etc) can be connected to a process /workflow. This enables the automatisation of tasks to be distributed or other actions for the object. An object with an active workflow connected to it has the cogwheel symbol seen to the right in the list. If clicking on that symbol the process / workflow for that exact object can be opened and the status of it can be followed. If hovering with the mouse over the ‘active’ box (marked orange), the system will show the user who is currently responsible for the object and what task has been sent to that person. The example above shows a process /workflow for a Deviation in the system.
  • Documents are created from templates the customer has predefined with their own logo, bookmarks etc.  Information about the document, eg the electronic signatures for approval can be printed on the document if required. Documents that are approved and valid are opened as PDFs, but the original word-file is still accessible in the system for those that have the rights to edit it for the next version. The system differentiates between Not registered copies (image) and registered copies. With the latter each print also has a unique number and is logged in the system.
  • To each document belongs a ‘document card’ with all required information about that specific document. For example, the training record of that document is found here, as are approval signatures, owner, date and responsible person for periodic review, log, template version, numbering in previous system, any relations to other documents or cases, enclosures, controlled copies and much more if required.
  • As every other object in Platina LS, each user also has an object card with descriptions of that user. Information such as which functions the user belongs to, what SOPs the user has signed off, other trainings he /she has participated in etc is all available at this card.
  • In Platina LS the same document or object (eg Deviaion, CAPA or CC) can be shown in several different contexts. This image shows the document (‘equipment cleaning instruction’) in the context of the function it belongs to – in the SOP folder where all effective SOPs in that functions are listed.
  • The same SOP (‘equipment cleaning instruction’) shown in the context of the Equipment it is connected to (the ‘container blender’) together with all other SOPs relevant to this equipment. Furthermore, from this view all other documents connected to this equipment are also directly accessible such as Technical information, Validation documents, Manuals etc.
  • Example of a Case card, in this case managing a deviation. A case card and the way it is managed in a workflow is very similar to how documents are managed from the document card. This makes the learning process easier for customers.
  • It is possible to connect Platina LS to a portal in which information from Platina QSM can be exposed, edited or initiated. The portal can be accessible from any mobile device. When the user had added the required information about e.g. a deviation, the portal sends it to Platina LS, using encrypted traffic if required. See next image.
  • The deviation initiated from the portal when viewed in Platina LS. The corresponding metadata fields are already filled in from the information given in the portal and can be further managed in Platina LS for e.g. investigation, evaluation, Risk assessment and sign off.