Business Accent

Balancing data issues

L V Sastry talks about the effective document management in pharmaceutical industry, which is the panacea for regulatory compliance.

The pharmaceutical industry is subject to stringent regulatory framework, and the industry has no choice but to comply. The industry is looking at prioritising investments to comply with current and future environmental directives. Most of the current and expected investments are in the areas of new technology or adoption of new business process innovations or spend in IT investments. Companies need business intelligence (BI), business process management (BPM), and product lifecycle management (PLM) expertise to deal with these regulations. Development of biotechnology, R&D performance, and regulatory compliance are the three key imperatives, which have become important for the traditional Indian pharma industry.

Content and documentation

Extensive information is considered to be the lifeline of a company and the repository of this information is scattered throughout the organisation. To address these requirements, enterprises must constantly reconsider and optimise the way they do business and change their information systems and applications, to support evolving business processes. In the pharmaceutical sector, workflow technologies facilitate these by providing methodologies and software to support by :

• Business process modelling to capture business processes as workflow specifications
• Business process re-engineering to optimise specified processes
• Workflow automation to generate implementations from workflow specifications

Traditionally, pharmaceutical companies and life sciences organisations have created and maintained large amounts of information—unstructured electronic data and paper-based content, ranging from information relating to the discovery of a molecule, through the development of the drug to clinical trials, regulatory reporting, marketing, sales and its eventual withdrawal. The effective management of unstructured information stored in documents in any organisation needs immediate attention. These documents may include research documentation, R&D documents, process manuals, quality manuals, audit documents, process inputs and outputs, drawings, training manuals, invoices, brochures, reports, video and audio files, photographs, faxes and others relating to compliance and regulatory processes. However, there are three important challenges with respect to the role of documents in the pharmaceutical industry in terms of efficiency, cost and regulatory compliance.

The efficiency challenge

A lot of information lives in unconnected, and in many cases, contradictory data relating to the location of the original research, the regulatory process in use where the clinical trials were conducted and where the product was to be marketed. The majority of the 550 medium or large organisations, which were studied, strongly agree that effective document management or workflow drives productivity (68 percent), customer service (66 percent), and a significant minority strongly agree that it drives competitive innovation (48 percent), profitability (47 percent) and revenue (38 percent). Fifty percent of organisations rate their organisation's document management less than effective in meeting their business priorities.

The cost challenge

According to Gartner, upto three percent of corporate revenues could be spent on printing and office output fleet (printers, copiers and faxes, and MFDs). As per International Data Corporation (IDC), 90 percent of companies do not track how much they spend on producing, printing and maintaining documents or the costs associated with output device management.

IDC calculates that changes brought about by new technologies, such as ERP systems, the Internet and intranets, print output volumes in offices are increasing by up to 21 percent per annum. This means that costs are increasing year-on-year in an area which is traditionally not measured and not managed. However, most of the organisations currently do not measure and monitor their printing output device related costs in the areas of copying, printing and faxing (costs towards asset acquisition, maintenance and running costs). So, the second very important issue remains spiralling costs, which can hamper the organisation's cost advantages seriously in a very competitive market place.

Regulatory compliance challenge

As mentioned earlier, the pharmaceutical industry is probably subject to the most regulatory framework in the world. This regulation by governmental agencies is to ensure that manufactured drugs have the correct identity, strength, quality, purity and potency. Besides, in the current business environment, with scandals such as Enron and Parmalat, companies now more than ever, need to operate an efficient documentation retention policy. All documents have to be fully retrievable, accessible and auditable throughout their lifecycle.

Also, with the ever-increasing volume of documents and their changing uses and formats, an effective document management system will greatly aid corporate compliance and continuity. A business continuity plan will demonstrate where the areas of highest risk are within the organisation.

Once the risk is quantified, the need would be to consider what contingencies need to be put in place, in order to reduce the impact of business disruption. Document management processes can help one achieve the right balance between cost and the likelihood of needing to implement the contingency. Another focus area for content management is the application process relating to analytical methods used to generate data for drug acceptance or release. It is a regulatory requirement that companies have to provide the auditors with such data, which gives information regarding specifications and documents relating to methods used to analyse raw materials.

In the event of error, this data also provides the precise audit trail back to the most detailed level of compound and usage. Hence, effective document management technologies, integrated workflow and content management appear to be the only panacea.

The cure

To address challenges as mentioned above and meet requirements, enterprises must constantly reconsider and optimise the way they do business and change their information systems and applications to support evolving business processes. Document management is one of the core areas of focus for implementing either a robust workflow process, or a regulatory compliance mechanism. Technology adoption in all areas in the pharmaceutical industry has become the single most important determinant for success in the twenty-first century. Using technology to manage information, especially unstructured content and documents, thus, becomes imperative for growth for this industry too. Effective and efficient document management is a large challenge for today's pharmaceutical companies. With such a wide variety of documents, everything from a company's specific departmental procedures to regulatory submission documentation organising and leveraging information is difficult and increasingly more important.

Effective document management can improve the way in which pharmaceutical companies store, manage and access business information; at their most advanced, they can transform business processes and the way the enterprise works.

All the efficiencies that can be gained in the model have been achieved. The entire document lifecycle is regulated from creation and editing to approval, publication and record management.

The EDMS way

Electronic Document Management Systems (EDMS) is a computer-based system used for managing electronic and paper-based documents. An EDMS generally offers a means of checking documents into the system, searching for documents in the system, and version control.

Many systems also provide workflow and collaboration capabilities. It is a subset of document management, electronic document management concentrates on data collected on web forms and internal administrative systems to ensure accurate handling of information. Electronic document management will also be the central hub of a digital rights management system. While the 'paperless office' remains the elusive myth, the aim is to move to 'less paper environment' Thus, EDMS aids this journey.

(The author is the Associate Director of Xerox Global Services)