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SAS Validation in the Pharmaceutical Industry

Edward D. Helton, Ph.D. SAS Institute Inc., Cary, NC James McNealy, SAS Institute Inc., Cary, NC Patricia Halley, SAS Institute Inc., Cary, NC Audun S. Runde, Ph.D., SAS Institute Inc., Cary, NC
SAS Institute Inc. has historically provided the standard analytic software to the pharmaceutical industry for the analysis and reporting of safety and efficacy data for drugs, biopharmaceuticals, and devices. Title 21 Part 11 has now placed a requirement on the industry to capture the day-to-day compliance of GXPs in a validated system. A validated system requires not only a development process that is accurate, is compliant, and provides the intended performance, but also a matrix of functionality that meets the predicate rules of the GXPs. SAS Institute Inc. has chosen to address these needs in two approaches that are compatible and can be integrated. The first represents the continued extension and upgrade of the SAS Quality Imperative through initiation of a new Quality Management System. Additionally, tools in Base SAS such as the Installation Verification Test (IQ) and the Feature Test Tool (OQ) in Version 9 are being added to the already present Part 11 enabling technologies such as the audit trail and data integrity constraint functions in Version 8.2. The second approach has been to develop de novo the SAS Drug Development (SDD) application or platform that from concept has been designed to enable Part 11 compliance. Similarly, a SAS Research Data Management application was developed to enable GLP compliance for the collection and warehousing of discovery data. These systems, applications and tools, can be integrated. In this presentation, we will present the ongoing work in the first of these areas. As we know Base SAS is a software language that can generate applications and GXP tools that will access, manage, analyze and report data. We also know that 21 CFR requires that GXP tools or technology must be calibrated, tested, standardized, and/or validated. The industry has done this repeatedly with Base SAS to develop GXP tools/applications. Compliant processes for requirements gathering, design, coding, testing and maintenance are routinely wrapped with SOPs by the industry. Migration from an earlier version of the SAS System to a more current version requires first assurances regarding installation qualification, as well as, operational qualification. The Installation Verification Tool (IVT) is presented as a means of assisting the regulated customer in demonstrating compliance and installation qualification. The IVT can be used as part of the installation process, as interim check on the state of the SAS System, and as an automated tool to maintain an audit history. The IVT will provide a binary signature for each file in the SAS System in the form of a 128 bit checksum. These checksums will be used to compare the files placed on media with the files in the customer image. Reports on the outcome of each IVT execution will provided in the form of traversable html and printable PDF. Examples of automated processes using the IVT will be discussed. The Feature Testing Tool (FTT) is presented as a means of assisting the regulated customer in demonstrating compliance and operational qualification. The FTT can be used as part of the initial qualification process, and as an automated tool to maintain an audit history. The FTT will provide the execution, processing, and reporting on tests provided by SAS Institute Inc. and customer written tests. The tests provided by SAS Institute Inc. are self-validating and require no benchmark file. The tool set will provide the necessary means of comparing test output with benchmark files that are maintained as the customer written test suite. The reporting aspect of the tool set will provide traversable html and printable PDF files. Examples of automation will be discussed. In summary, this paper and presentation will review in detail the ongoing efforts at SAS Institute Inc. to meet the elements of Part 11 compliance through enhancements of core SAS Products. SAS Institute Inc. recognizes that the product sponsor in the regulatory development and review process must go through a qualification process supported by SOPs for migration to new versions of the SAS System. The available tools and strategies with SOPs will be reviewed with relevant migration requirements. We also plan to address migration and integration solutions for new Base SAS technology with the new releases of Part 11 compliance enabling technology. CONTACT INFORMATION Your comments and questions are valued and encouraged. Contact the authors at: Edward D. Helton, Ph.D. SAS Institute Inc. SAS Campus Drive Cary, NC 27513 Phone: (919) 531-4062 Fax: (919) 677-4444 Email: ed.helton@sas.com Web: www.sas.com James McNealy SAS Institute Inc. SAS Campus Drive Cary, NC 27513 Phone: (919) 531-5174 Fax: (919) 677-4444 Email: james.mcnealy@sas.com Web: www.sas.com Patricia Halley SAS Institute Inc. SAS Campus Drive Cary, NC 27513 Phone: (919) 531-0566 Fax: (919) 677-4444 Email: trish.halley@sas.com Web: www.sas.com Audun S. Runde, Ph.D. SAS Institute Inc. SAS Campus Drive Cary, NC 27513 Phone: (919) 531-3265 Fax: (919) 677-4444 Email: audun.runde@sas.com Web: www.sas.com
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