Pharmaceutical companies are often among the largest and most complicated organisations in the private sector, and while their size is often a measure of their success, it can also cause them significant operational problems – not least with their information management.
A large pharma firm can have tens or hundreds of thousands of employees in offices all around the globe; furthermore, there is the sheer variety of different departments and roles within the organisation, encompassing chemists, pharmacists, biologists, patent attorneys, marketing, legal staff and many more.
These different departments all generate huge amounts of data, contained within reams of digital documentation. Indeed, one major European drug manufacturer recently admitted that its data volumes are doubling every 15 months. The problem facing pharmaceutical companies is that much of the data generated by different departments is needed across the organisation; however, it is often extremely difficult, if not impossible to share this information among different people, premises and departments.
Nor is internal data sharing the only issue. The pharmaceutical industry is also unique within the private sector for the close scrutiny and complex regulation to which it is subject. While this level of bureaucracy is necessary for ensuring the highest standards of public health and safety, it can cause major headaches for pharma companies when they are required to provide information, such as clinical trial data or audit trails, to external authorities.
The problem stems from the multiplicity of software and systems in use across all the different departments within a large pharma organisation. Naturally, this goes far beyond the word processing, spreadsheet and presentation applications used by businesses in other sectors. For example, the chemists alone can use around 200 separate pieces of highly specialised software to design, refine and test drugs; including biomolecular modelling, semi-empirical, molecular mechanics and valence bonds programs, to name just four types. Unsurprisingly, these software applications are not supported by off-the-shelf collaboration tools such as Microsoft SharePoint.
All these different applications use different codes, languages and standards, and it is usually either extremely difficult or completely impossible to share and integrate content among them. Yet even if there were one single standard for content pharma companies would still have to overcome the problems inherent in the complexity, size and geographic diversity of their operations. In large, complex organisations like these, valuable data and content are usually siloed in a plethora of different machines, desktops, servers, premises and potentially even in different countries and continents.
The difficulties involved in finding, obtaining and integrating data slows still further the long process of getting a new drug or device onto the market. And, like any delays, they are harming pharma firms’ profitability.
The information management needs of the industry require more specialised collaborative working systems than generic software used by other businesses. But while most, if not all, pharma companies have specialised enterprise content management (ECM) technology, even systems specifically designed for the pharma industry are rarely more than a suite of off-the-shelf components.
At a recent roundtable held by Open Text, senior players in the pharma industries highlighted several key challenges that traditional ECM software has so far been unable to solve. One of the issues raised was the management of regulated content – in other words, data collected and submitted to regulatory authorities or subject to legal, regulatory and ethical constraints, such as medical records. It is vital that access to regulated content is restricted to those with legitimate authority to view it; at the same time, this information must be structured and searchable to ensure that information can easily be found when it is requested by outside agencies such as regulators, auditors, investigators or insurers.
Another concern highlighted at the event was the issue of data integration. This needs to be done in a federated manner by implementing data exchange standards and introducing a semantic layer to facilitate navigation and data recall across the multitude of different systems and formats.
Closely related to this issue is the challenge of managing content itself, rather than just the documents in which that content resides. The inability to access or share data across an organisation means that it is often very difficult to find, access and re-use the ‘intelligence’ within pharma companies’ legacy documents. This slows down document workflow, as well as any associated auditing process, which ultimately slows down the time-to-market of the products involved.
These were only the standout issues raised at Open Text’s pharma roundtable, and there were many other problems raised and discussed at the event. But if there was one theme that united many of the problems identified, it was the urgent necessity of semantic, or ‘sense-making’ technologies that enable users to find relevant content quickly and easily, wherever it may reside in the organisation.
As noted above, there are a number of different content management technologies specifically designed to meet the needs of the pharma industry. Yet the fact that the roundtable attendees were able to identify – and agree on – several significant content management difficulties speaks volumes about the failure of these systems to meet pharma companies’ requirements.
While there is no single silver bullet, no overarching technology suite or process methodology available for solving these problems, doing nothing and sticking with the same old systems is merely a counsel of despair.
What, then, is the answer? Open Text believes that pharma companies cannot simply wait around for technology providers to come up with a panacea to all their problems. Content management vendors can produce systems for separate business functions, departments and processes; but if we are to solve the wider issue of effective data sharing across the whole organisation, a new, holistic approach is needed. This can be achieved only with the direct input of pharma firms themselves.
The industry therefore needs to engage actively in the development of new standards, processes and technologies. They can best do this by working closely with content manage-ment vendors to help identify the specific challenges they face in creating, managing, auditing and sharing the superabundance of invaluable data that they hold.
No content management vendor can truthfully claim to have the answer to the multitudinous issues surrounding information management in this industry. Nor will they, unless they begin reaching out to pharmaceutical companies, listening to their experience and fully understanding their needs.
This will not be a quick win; and pharma firms cannot expect a miracle cure to appear overnight. But the prize is one of real and lasting value: an holistic information management system that will transform data sharing across organisations, leading to more rigorous safeguards, faster time-to-market and increased profitability. It is imperative that the industry starts to take responsibility for coming up with effective data management systems, because the current dearth of such technology shows the unwisdom of inaction.
Genzyme invests in global document management
Biotech company Genzyme has approximately 9,500 employees in more than 70 locations across 30 countries, including 17 manufacturing sites and nine generic testing labs. With multiple worldwide locations and strict compliance regulations to adhere to, it is no wonder that Genzyme’s biggest document and knowledge management challenges were keeping everything organised and everybody informed.
‘Remote sites were experiencing significant delays in document download, upload and viewing,’ says Mark Wescott, Genzyme Senior IT manager, ECM. ‘For example, a 10MB file that might take a few seconds in the area where our server is located here in eastern Massachusetts, could take several minutes at some of our remote sites due to three factors: bandwidth, latency and congestion. Unfortunately, these factors play together to reduce the speed of the document transfers.’
To accommodate better its users on a global scale Genzyme rolled out Open Text Document Management (DM) globally. ‘We need to ensure we have access to and the most recent versions of business critical documents such as SOPs for our manufacturing, quality and any operation that has an effect on our products. This includes the IT systems that support these functions. These SOPs need to be tracked through their entire document lifecycle including the creation, approval revision superseding and obsolescence of the document,’ says Wescott. Open Text ECM suite is the document management system that Genzyme uses to meet these requirements.
The Open Text document repository functions allow Genzyme to store every version of the document along with the meta data. ‘The audit trail gives us complete information on all transactions performed in the documents. Plus, the Electronic Signature module electronically approves documents and keeps us 21 CFR Part 11 compliant.’
‘Open Text is centrally deployed,’ says Wescott. ‘We currently have two Open Text systems at Genzyme. Our controlled system, which is the smaller validated instance, has Workflow, Electronic Signature, Adlib, Forms and it has an interface to our Learning Management System. This is where our SOPs, validation documents and other controlled documents are kept. And we also have our production instance, or our much larger, more collaborative instance, which stores other corporate information. This instance has Open Text Explore Professional and serves as our back end storage for the content on our portal intranet.’
Genzyme first deployed a single department roll-out of the Open Text system to its Regulatory Affairs organisation. Gradually it built upon this document management infrastructure adding Workflow, Remote Cache and Electronic Signatures, the first solution to give regulated industries an electronic process for managing legally binding e-signatures to key documents across a large enterprise.
‘We use Open Text forms as a front end for many of our workflows. This allows users to perform the necessary transaction using a form-based interface that they are already familiar with,’ says Wescott. ‘For instance, previously we used a paper DCR form. With DM, we can make the electronic one mimic the paper form, so it reduces the learning curve.’
‘Open Text provides a great way to share information across many business units, across different geographical boundaries...anything from meeting agendas and minutes to detailed project plans,’ says Wescott. ‘And the notification feature is a critical part of that collaboration. Project teams or individuals can be notified by e-mail when something of interest changes. For example, with documents that have been added or deleted, or versions have been added or deleted, or when tasks or workflow steps are due or require their attention.’
Many of the Genzyme sites have adopted Open Text Workflow for their document approval process. ‘We have workflows in place for SOP approval, routine change control, product label control and lab systems change control, as well as periodic review of documents. These workflows vary from very simple to very complex, depending on the business process that they are automating. The nice thing about it is that you don’t have to mould the business process to fit the tool, you can mould the tool to fit the business process,’ says Wescott.
