quality

Quality and Innovation From Bench to Clinic – the Role of Data Integrity

According to a recent PwC survey of pharma CEOs, 35% consider strengthening innovation a top priority. At the same time, they are facing increasing challenges from more stringent regulatory requirements and rising standards of quality.

The Life Sciences track at this year’s Enterprise World looks at the benefits of building the quality-centric enterprise within Life Sciences. Data integrity is a foundation stone of quality and at the very heart of Digital Transformation. How can organizations gain visibility and control over all their data?

Digital Transformation, for me, is not just about replacing paper with digital-based processes. It is about releasing the value that an enterprise has in the data it holds. The challenge is that most organizations have developed as a series of departmental silos.

This is certainly true for quality. Separate departments or business units have created their own home-grown or legacy systems – often on Excel spreadsheets – to manage product and process quality. Apart from being hugely expensive to maintain and prone to error, these systems lack any enterprise-wide visibility, ability to share information across the organization and its partners, or to manage by exception.

How reliable is your quality data?

Despite best efforts, the data held within many of these quality systems must be considered less than reliable. Estimates indicate that bringing a new drug to market costs more than a billion dollars and takes up to 15 years so the effective use of quality data can help drive innovation and reduce costs.

For example, a new product submission to the FDA can run to 600,000 pages containing data from a wide range of sources. The proper document management of that submission is essential to remove error and cost from the process.

Companies are faced with regulatory requirements such as GxPs, reporting mandates, international quality standards and other compliance issues. This is simply part of daily operations and assuring the integrity of data feeding and driving these systems is paramount.

This situation would be challenging enough if it were only internal data that the organization had to worry about – neatly held within enterprise applications and databases.

However, every Life Sciences company operates in an ecosystem of customers, supplier and research partners. The amount of data is exploding and most of it is unstructured. According to The Economist, as of 2017, more than 1.7 billion healthcare and fitness apps have been downloaded onto smart phones. These apps are collecting mountains of valuable data that companies can use to improve product development and inform innovation.

Towards the quality-centric organization

To become a quality-centric organization, you have to be able to effectively many multiple data types from multiple sources. This data has to be reliable and available to drive quality through your entire ecosystem (See figure 1).

Figure 1: Key drivers for the end-to-end, quality-centric Life Sciences organization

Supplier Enterprise Customer
Supplier audit

Containment & failure analysis

Supplier corrective action

Cost recovery

Supplier KPI/scorecard

Inspection/audits

Non-conformance

CAPA

Containment & failure analysis

Document control & records management

Change control

Digital marketing & communication

Training

Equipment calibration

Safety management

Quality scorecard

Customer issue & complaint management

CAPA

Containment & failure analysis

Change control

Document control & records management

Product change notification

Quality scorecard

 

It is difficult – if not impossible – to achieve this level of data integrity without a central platform to manage that data and content.

With the Documentum acquisition, OpenText is uniquely positioned to provide the most comprehensive Enterprise Information Management platform to Life Sciences companies. Enterprise application integration, B2B integration and advanced analytics build out the ECM solution to give you new levels of visibility and control of the data across end-to-end business processes.

This is the focus for Enterprise World. There will be speakers from some of the world’s largest Life Sciences brands talking about their experiences of driving quality and innovation within their companies.

There are still a few spaces available so register today. It would be great to see you there.

About Jaleel Shujath

Jaleel Shujath
Jaleel is an Industry Strategist in Life Sciences for OpenText, based near Washington DC.

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