The FDA regulated life science industries are highly paper intensive and generate enormous amounts of documents to comply with various regulations in all areas (research, manufacturing, clinical, labs, etc.). Typically companies use document management systems, and as a result, information and data resides in unstructured documents.  Companies have a hard time converting this information into knowledge.

One of the ways companies can move to the knowledge management platform is to store information in a structured way and use it in that form.  They have to become knowledge centric and not remain document (“MS Word®”) centric. This is a document intensive industry where traceability and managing change is essential throughout any process life-cycle.

ValiMation has partnered with Telelogic, a leading global provider of software and services for Enterprise Lifecycle Management (ELM). ValiMation provides a system life-cycle management software that is database driven, yet works like a word processing package, has robust traceability, security, and audit trail features. This is built on Telelogic DOORS® platform which was ranked as the BEST Requirements Management product. Read More...

Our Traceability Solutions include:

We "Bio-Pharmacize" DOORS® - to meet the specific needs of the regulated
    life sciences industry.

We provide “Bio-Pharma DOORS®-IN-A-BOX” solution that our clients can plug
    into their networks and start using it without worrying about validating DOORS®
    itself. In other words, we provide vCOTS (Validated Commercial-Off-The-Shelf)
    version of DOORS® that include Telelogic DOORS®, hardware, customizations
    (if any), content and a validation package.

Provide a GxP Knowledgebase in DOORS® that will help clients validate and
    maintain the validated state of various systems (e.g.: provide validation
    lifecycle templates through DOORS®, automate DOORS® to word conversion,
    validation best practice templates in DOORS® format, etc.).

We can leverage our offices in Bangalore, India to develop these solutions at a
    cost-effective price – Provide a High Quality Next Generation System with High
    ROI.