Making the Switch to Electronic Record Keeping

Electronic records and signatures have significant advantages over paper records and handwritten signatures and are expected to accelerate drug development and approval. This is especially true in the US where the Food and Drug Administration (FDA) issued regulations in 1997 that govern the electronic record keeping of companies that market their products in the US. This rule, which is known as the 21 Code of Federal Regulations (CFR) Part 11, was welcomed by the pharmaceutical industry to facilitate the maintenance and retrieval of analytical records and reduce space requirements. But the implementation of electronic record keeping can require significant changes in instrumentation, work processes, and software functionality. For background information and a general overview of these provisions, you may wish to access an earlier feature article, Following a Paperless Paper Trail .

21 CFR Part 11 has a tremendous impact on the business model of any drug sold in the US. The FDA can inspect any aspect of a company's electronic operations, from new drug identification and development to manufacturing, and in cases of noncompliance, deny that company the right to sell a drug in the US, resulting in millions of dollars of unrealized revenue. For this reason, these provisions continue to generate a great deal of debate about the most effective methods to satisfy the FDA's requirements. This article will focus on two key issues addressed by 21 CFR Part 11: data integrity and traceability, areas in which the FDA has recently cited a number of deficiencies.

Ensuring the ability to recreate results

Perhaps the most demanding portions of 21 CFR Part 11 are those that have to do with data integrity and traceability. These provisions require electronic records that allow the FDA to recreate the final results from the raw data by using the same tools the user had when the original data was generated.

Data integrity: To meet data integrity requirements, final results must be stored with both the raw data and the procedures for processing that data (also called metadata) in a way that protects them from accidental or intentional modification, falsification, or deletion. And test procedures must be recorded as they occur, so data is in context and follows the FDA's permitted workflow sequence.

In addition, a record must be kept of any instrument and processing errors that caused test results to be rejected. In chromatography data, for example, all changes made to the integration parameters of a specific injection within a sequence must be recorded as well as the reason the analysis result was excluded. Referential integrity between all of these related electronic records must be maintained.

Traceability: This refers to the computerized audit trail of the laboratory's data system. This record of who did what to a record when must be computer-generated, time-stamped, and stored securely. All entries in the audit trail must be unobscured by any subsequent deletions or modifications.

Record keeping with this level of detail can add 15% to 30% to the cost of research and development. In many pharmaceutical laboratories, one-size-fits-all software programs that require the manual transfer of data from one system to another exacerbate this problem.

Providing support and solutions

21 CFR Part 11 presents many challenges that increase the importance of cooperation between pharmaceutical manufacturers and the companies who provide them with high technology solutions. Agilent Technology's vendor assistance program in support of FDA compliance is recognized by many as an industry standard. It begins with software solutions that provide secure, operator-independent audit trails, and systems that store metadata with the raw data file so that the originally obtained final results can be reconstructed instantly. Agilent's Networked Data Systems focus on lab-specific software that mimics the way analysts work to provide workflow support from sample registration through final report. This reduces the need for manual entries and calculations, resulting in lower validation costs and higher productivity. A scalable client/server architecture makes it possible to connect a few hundred chromatographic instruments, and eliminates the need for multiple data systems.

Networked Data Systems provide fast and error-free data collection from multiple Agilent chemical analysis instruments.

For more information

Agilent is committed to providing compliance solutions and support for its partners. To learn about the wide range of choices, please visit the Networked Data Systems section of our Web site. An extensive curriculum of related courses, as well as a complete portfolio of compliance services, are also available on the Customer Support Services section of this Web site.

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