Gain full visibility across your data landscape, find meaning in your data and improve the quality of business decisions.
Discover and download solutions and pre-built integrations for the Collibra Platform.
Get unparalleled value through the combined expertise and unique strengths of our people and technology.
See how security plays a key role in everything from how we build and deliver our platform to how we hire and train employees.
Collibra Privacy & Risk
Discover and understand data that matters so you can generate impactful insights that drive business value.
Understand your ever-growing amount of data in a way that scales with growth and change.
Show how data sets are built, aggregated, sourced and used, providing complete, end-to-end lineage visualization.
Build customer trust by operationalizing privacy policies and scaling compliance across new regulations.
Modernize your operations with a solution that is scalable, accessible and resilient: data in the cloud.
Drive digital growth and customer engagement by breaking down data silos and adding value to customer interactions.
Fuel your self-services analytics with the right data to develop unique business insights.
Innovate for the future while successfully navigating the complex web of regulations.
Transform decision making in the public sector with secure Data Intelligence that is FedRAMP Authorized.
Cloud ready data
Government and public sector
Tap into our knowledge base by connecting, sharing and learning from your peers in our Data Citizens community.
See how Collibra is helping global organizations unlock the value of their data.
Find the resources you need to accelerate time to value and fuel your growth.
Learn from the leaders in Data Intelligence through our individual courses, learning paths, and certification programs.
Data Citizens '20
Take your data strategy to the next level by arming yourself with the knowledge you need to achieve Data Intelligence.
Get advice, tips and tricks from our product experts and industry thought leaders to learn how to make your data meaningful.
Join the world’s largest virtual gathering of professionals focused on empowering businesses to deliver on strategic goals through Data Intelligence.
Check our upcoming events calendar to discover exciting opportunities to learn from our product and industry experts.
Connect the right data, insights, algorithms and people to optimize processes, increase efficiency and drive innovation.
Read our latest announcements, news coverage and thought leadership articles.
Find an opportunity to challenge and be challenged, and work with some of the most talented people in the business.
Get in touch with a member of our global team by locating an office near you, calling us or sending an email.
By 2018, all global vendors of medicinal products (pharmaceutical companies) that operate globally or in the European market will be obliged to ensure that all submissions of product information follow a standardized data model with standard vocabularies and code sets. This standardized data model is defined by the ISO IDMP set of standards. Companies can face hefty fines for non-compliance.
In the first of a series of articles, we present some basic IDMP concepts and why data governance is important for the industry to tackle the complexity and the data among their different systems.
IDMP – Identification of Medicinal Products – is a set of ISO global standards designed to support the unequivocal identification and description of medicinal products throughout their entire lifecycle. This lifecycle – from research to production, marketing and pharmacovigilance – involves a complex and variable set of attributes and a range of systems across departments. Even within the same company, this complexity already requires strong governance.
To support global identification of products, the IDMP standards harmonize key concepts, as well as their relations, meaning and attributes; this enables consistent terminologies, naming standards, etc.
Source: official graphic from ISO TC 215, WG6
The picture above shows the key concepts in IDMP, and how they relate to each other: Pharmaceutical Product (i.e. a formulation, which includes the substances and other attributes); Medicinal Product (the marketable form, or commercially available product); product characteristics like units of measure, dose form, etc.; and the many details and rules around these concepts.
Regulatory authorities (e.g. EMA in Europe) are relying on IDMP, and pharmaceutical companies are expected to submit their product information in an IDMP-compatible way. InThis means that pharmaceutical companies need to adopt IDMP and govern their data to ensure:
With such great complexity, and such business impact and penalties for non-compliance, IDMP adoption is not only an IT problem, but must be well governed by the business areas – Research, Regulatory, IP, etc.
This is where data governance shows its advantages. It brings the complexity to an understandable, traceable process, avoiding many spreadsheets and scattered technical communication.
Data governance does not mean ignoring details or creating shortcuts. It is about giving executives and non-technical people the insight into what data is need, where, and how much of that data respects the internal governance aspects.
Concrete IDMP example:
ISO 11616 defines some concepts and attributes and rules – e.g. the Pharmaceutical Product is identified bythe Pharmaceutical Product ID, and is defined by attributes like Substance, Strength, Dose Form, Device, etc. The details on substances are further harmonized by ISO 11238.
But the standard does not define the value sets for substances – they are defined elsewhere, e.g. by the GINAS system and value set, which is made available from the Global Substance Registration System (G-SRS)system, hosted by the WHO in Uppsala, Sweden. The same SRS value set is used in the UNII which can be accessed from the NLM/NIH. Similarly, the units of measure are harmonized by ISO 11240, and the code list is UCUM, which is available from unitsofmeasure.org. Dose Forms (among others) are normalized by 11239 and a reference value set is the Standard Terms dictionary, maintained by the EDQM. If multiple value sets can exist, this usually implies a need for governing each of these value sets.
ISO 11615 states that a Pharmaceutical product is present in the Medicinal Product, which is identified by a Medicinal Product ID, and has attributes like Marketing Authorisation Number, Classification, Name (where Name can have components like invented name, strength, intended use, etc). The Medicinal Product is packaged as Packaged Medicinal Product, which has other attributes… These many attributes are associated with a set of rules about cardinality, optionality, uniqueness, etc.
So this is fairly comprehensive, and companies must master this model and their IT systems must show to respect the rules. Instead of using many spreadsheets, data governance solutions enable these concepts to be visualized and traced in an accessible manner:
The figure above shows several types of concepts and their articulation:
Data governance enables organizations to capture the same concepts and structure described above in a simple, traceable manner, which enables organizations to understand and monitor all aspects without delving into the IT aspects. Without data governance, these relations would be much harder to manage, even just for the small sub-set above.
Focusing on business aspects makes it possible to include other governance aspects like the rules – e.g. attributes may be optional or mandatory, identifiers have to be unique in some conditions, and more. Data governance enables not only to explore these rules and their traceability to the other assets, but also to actually check whether those rules are properly enforced in the systems that hold the data. In other words, not just in the model, but monitoring the actual data in the IT systems. But that is for another article.
Together with its customers, Collibra is establishing a reference implementation for IDMP (among other areas where healthcare and life science industries can benefit from data governance), to enable a fast adoption of data governance throughout the institution and where it matters for compliance.
We accelerate trusted business outcomes by connecting the right data, insights, algorithms and people for all Data Citizens.
© 2020 Collibra. All Rights Reserved.
A message to our Collibra community on COVID-19. Read more from our CEO.