The importance of information control for compliance in the pharmaceuticals industry

Tim Taylor, Chief Business Development Officer at McLaren, looks at the role that IT can play in the improvement of process automation and control to positively benefit business strategies. An effective information management strategy can support companies, rather than hamper them, enabling them to build an organisation and systems that can manage extended global business applications in a compliant and efficient fashion.

Compliance and validation are two key words in the pharmaceutical dictionary and they both shape organisations' information management strategies.

With electronic signatures and the audit trail now a key focus under the draft guidance of early 2003 for 21CFR Part 11, there has been a rise in the demand for validated software solutions to help companies become compliant. However, software solutions needing extensive customisation often involve expensive and time-consuming consultancy work, holding up the eventual validation of documents, systems and processes and delaying compliance. This is perhaps missing the crux of the information management debate.

Truly successful information management is about the effective handling and evolution of company-wide business processes, regardless of the system chosen. The solution chosen should map onto these processes, rather than vice versa. Currently, many businesses are finding that technology is dictating business operations. This common scenario is slowing down organisational change, at the exact point when time to market is the key driver in the pharmaceutical sector.

Time to market

The process of bringing a drug to market is spread out over years and spans multiple departments within a company, which makes keeping track of progress on individual projects a complicated task. Document management solutions are installed to allow the manufacturer to maintain control over the flow of documents, keep on track with approvals and grant access permissions. An effective document management system encourages accountability through the creation of audit trails to determine where documents have been amended and by whom. This control is essential if drug dossiers are to be submitted to the FDA for approval in a timely manner.

Any documents submitted to the FDA for validation, under 21CFR Part 11, are recommended to be easily searched, sorted and trended in a human readable form, and audit trails in particular must be time-stamped to ensure their trustworthiness and reliability. This means that document management must be enterprise-wide, in order that deliverables from third-party contractors, for example, the engineering documentation for the pharmaceutical manufacturing plants, or in-house developers, can be easily accessed and collated by the project managers, cutting down on the time needed for an organisation to prepare for validation.

Configuration versus customisation

Databases and other information management software have been developed to deal with structured data such as spreadsheets and accounts. However, configurable out-of-the-box applications are now available, designed to manage inherently unstructured data (e.g. drawings, designs, written material - the types of document a pharmaceutical company needs to deal in), affording them a great deal more flexibility than a customised solution.

Configurable applications have developed from Rapid Application Development (RAD) tools, allowing businesses to tailor a generic platform to meet specific business requirements. They come with best practice heritage as standard, including common business rules and a historical perspective on how the final application was developed, which is a crucial consideration for businesses operating in a heavily regulated environment. The pharmaceutical industry can profit from this approach more than other sectors as any system changes or amendments have to be fully validated and compliant with GMP guidelines and the recent ER/ES rules for managing electronic information. Configurable applications remove complex software alterations for system upgrades and so eliminate the need for lengthy system re-validation - a significant cost saving.

All of this means that configurable document management systems within the pharmaceutical industry can reduce implementation times, return the ownership of the applications to the customer rather than the consultant, and reduce costs of future changes as internal staff can manage the process.

Concurrent document modification

Particularly within the pharmaceutical industry, demand is high for concurrent working - i.e. multiple parallel authoring of drawings and documents. Effective information management software should also support this, accelerating project management and completion, saving time, cost and effort as well as delivering a faster ROI on complex projects.

Often several parties will be working on different projects but will need access to the same drawings and documents. Good concurrent engineering applications should allow each particular project worker to make a copy of the required drawings and documents, based upon a predefined project policy template, and work on that copy.

The template details relevant project information, such as required attribute information, as well as a full audit history of accessed documentation. Once complete, the first project merges back into the master documents and a new revision is created that can then be approved and released as the new master document.

As subsequent parties request project copies, email notification is sent to the relevant responsible person(s) to highlight that a new project copy of the document is being accessed elsewhere. When subsequent drawings are re-submitted, concurrent engineering applications should recognise whether the master document that was used by this project copy has subsequently been revised and hence whether or not a manual check is required before the merge process can be completed.

Maximise intellectual property

Collaborative working can give more control to a business as information is handled and managed on an enterprise-wide basis. Having configurable applications also means that documentation can be validated in a shorter time, as often if a system is amended through customisation it needs revalidating.

The DM market is evolving, particularly in the pharmaceutical industry, where customisable software has not been meeting particular needs. Now there are out-of-the-box applications which can help organisations share information across the enterprise, eliminating departmental "tunnel vision" (where one department concentrates on just one function) and allowing organisations to marry contact with business processes, maximising their intellectual property through control and thus delivering real competitive advantage.