DOCUMENT MANAGEMENT

Electronic Document Management Gets Small

These systems can prevent small companies from drowning in paperwork

T he pharmaceutical industry's highly regulated environment means that effective document management processes are increasingly important. In addition to the strict regulatory environment that encompasses pharmaceutical documentation, pharmaceutical companies must also find ways of dealing with the increasing amount of information that must be processed.

A recent report pointed out that the average information worker spends up to a quarter of each day searching for relevant information, with each document unnecessarily copied an average of 19 times. In order to overcome these challenges, many pharmaceutical companies are now using electronic document management systems (EDMS) to streamline document storage and retrieval.

EDMS are clearly needed in the pharmaceutical industry, but there are a number of questions regarding the regulatory issues that affect the use of an effective system for pharmaceutical document management.

Document Management

A screen shot of an electronic data management system. These systems can help streamline work flow and maximize resources.

Pharmaceutical companies traditionally produce and store large amounts of information, both electronic and paper-based. This information can exist in many divisions of a company, including drug development, marketing, and sales reporting. Documentation within the pharmaceutical industry is subject to strict regulation by both governmental rulings and agency guidelines, and there are a number of rules covering electronic documents.

The U.S. Food and Drug Administration (FDA) Title 21 CFR Part 11 guidelines deal with electronic records and electronic signatures and define the criteria under which these are considered to be trustworthy, reliable, and equivalent to paper records. The regulations require pharmaceutical and biotech companies and medical device manufacturers to implement certain controls-such as audit trails, validation systems, and electronic signatures-as part of business processes and product development. This requirement means that all electronic documents within a pharmaceutical organization must be fully retrievable and accessible, with a clear audit trail.

Regulatory submissions traditionally involve large amounts of paper-based documentation that must be physically sent to the relevant authorities. This can be an extremely time-consuming and expensive process, considering reviews or modifications often made to the documents throughout the development life cycle.

In 2002, the Sarbanes-Oxley Act (also known as the Public Company Accounting Reform and Investor Protection Act) added requirements to FDA guidelines. The act, which was introduced in response to a number of major corporate scandals, including Enron, covers issues such as auditor independence and corporate governance and aims to ensure that directors have a legal responsibility to verify that certain standards are met within an organization.

Many documents within a pharmaceutical organization can now be signed electronically. Electronically signed documents, sealed and encrypted in an EDMS, protect both the signer and the company and follow a standards-based format that allows third-party agencies to easily verify the document. If the document is changed after the signature has been saved, verification will fail, ensuring that non-repudiation works as well as it does with paper-based signatures.

Regulatory submissions using the Electronic Common Technical Document (eCTD) are becoming increasingly common in the pharmaceutical industry; agencies may soon insist upon this method as part of FDA 21 CFR Part 11 guidelines. By using eCTD for regulatory submissions, pharmaceutical companies can minimize the time and costs spent on product development.

Regulatory submissions traditionally involve large amounts of paper-based documentation that must be physically sent to the relevant authorities. This can be an extremely time-consuming and expensive process, considering reviews or modifications often made to the documents throughout the development life cycle. Using eCTD can help to improve and standardize the process of regulatory submissions; however, pharmaceutical companies must ensure that electronic documentation is subject to the same audit controls as paper-based information.

In order to streamline work flows and facilitate compliance, pharmaceutical organizations should have an EDMS in place that underpins these stringent regulations. Additionally, companies dealing with electronic regulatory submissions often ask that the relevant electronic documents be in a standardized format and that they have a full version history and audit trail. By using an EDMS, pharmaceutical organizations can standardize regulatory submissions and manage documentation in a compliant way.

A Regulatory Compliance Aid

Many documents within a pharmaceutical organization can now be signed electronically within an electronic data management system.

With the ever-increasing volume of documents in the pharmaceutical industry, an effective document management system can be a significant help in regulatory compliance. EDMS are already used by large pharmaceutical organizations, providing an effective and streamlined system for managing information. Although the cost of buying and implementing such systems can be prohibitive for small to mid-size companies, there is now an even greater emphasis for compliance with a number of standards, and smaller companies put themselves at risk of becoming overwhelmed with paperwork.

Good Products, Ltd. (Nottingham, United Kingdom) has developed its EDMS portfolio (g-docs, g-train, and CoSign) with the aim of reducing the costs involved with software licenses, implementation, and hardware infrastructure. A number of factors can help to minimize these costs; for example, some new EDMS are built on commonly used platforms such as Microsoft Share-Point, part of the Microsoft Office suite. By using an existing platform, EDMS providers can reduce the amount of original software development required, resulting in a more cost-effective product that can be easily integrated with other line-of-business applications. Additionally, Microsoft is a platform and program format with which most users are already familiar, a benefit that reduces product training.

Digital signatures have now been upheld in U.S. court as the equivalent of wet signatures and cover every requirement of the FDA 21 CFR Part 11 guidelines. Many electronic signature solutions are also easily integrated into commonly used programs such as Microsoft Office and Adobe.

Large project implementation costs will be increased by the need to purchase additional hardware to host the EDMS. For smaller pharmaceutical organizations, the software can be hosted externally, with the solution accessed via the Internet. A Web-based EDMS provides an easy-to-use environment where documents are interfaced with Microsoft Office, keeping training time to a minimum.

In order to further reduce the cost and resources involved with the implementation of EDMS, some software providers offer a consultancy service to help organizations install EDMS at the lowest cost and with optimum efficiency. With larger established document management systems, inflexibility makes it necessary to change existing management processes to suit the software, but Good Products and its g-docs product provide an EDMS that can adapt to the pharmaceutical customer's work flow. This approach can help to lower the overall cost of implementing such a system.

Small to mid-size pharmaceutical companies can now implement an effective EDMS. With the deployment of flexible EDMS, companies can enjoy benefits like CoSign, with digital signatures. Digital signatures have now been upheld in U.S. court as the equivalent of wet signatures and cover every requirement of the FDA 21 CFR Part 11 guidelines. Many electronic signature solutions are also easily integrated into commonly used programs such as Microsoft Office and Adobe.

With document management regulations becoming more stringent, and with the increasing amount of information being processed by pharmaceutical organizations, it is now essential even for smaller companies to implement document management solutions. While prohibitive costs have traditionally excluded small to mid-size businesses, companies such as Good Products recognize the importance of providing all organizations with a credible alternative to expensive EDMS solutions that require extensive installation and training programs. It is now possible to integrate additional processes into an EDMS-for example, digital signing-to further streamline work flows and maximize resources for pharmaceutical organizations. �