Software research and assessment firm Technology Evaluation Centers, Inc. has partnered with pharmaceutical software provider Deacom, Inc. to release an industry executive report discussing technology issues that complicate Food and Drug Administration compliance and offering guidelines for implementing a compliance plan and evaluating regulatory compliance software.
The report, “Strategies for Overcoming Compliancy Issues in the Pharmaceutical Industry,” explores requirements of 21 CFR Part 11 and current Good Manufacturing Practices (cGMPs) that can be difficult to meet for pharmaceutical manufacturers using siloed systems, legacy software programs, and manual processes to manage their businesses. Achieving standards for electronic record security and traceability and enforcing process controls in production and laboratory management are particularly challenging in this type of technology environment.
By providing guidelines for developing and implementing an internal compliance policy, and a detailed checklist for vetting regulatory compliance software solutions, the report aims to help manufacturers meet these requirements more easily.
“We recommend a structured, four-step process for creating a compliance plan,” says Aleksey Osintsev, research analyst at TEC. “Combine that with the regulatory compliance software criteria TEC has developed through experience with pharmaceutical manufacturers and ERP systems designed for the industry, this report is a valuable tool.”
“Strategies for Overcoming Compliancy Issues in the Pharmaceutical Industry” is available for download at www.technologyevaluation.com.
To learn more about the DEACOM Integrated Accounting and ERP Software System or to schedule an online demonstration, call 610-971-2278 ext. 15 or visit www.deacom.net.
About Technology Evaluation Centers, Inc.
Technology Evaluation Centers (TEC) provides insight and expertise in offering impartial resources and services to minimize the costs, risks, and time associated with software selection. Over 3.5 million technology decision-makers visit TEC’s Web sites each month, to find information on hundreds of solutions, and to access articles, white papers, and podcasts. TEC’s decision support system (DSS) and analyst data assist with the evaluation, comparison, and selection of enterprise solutions and services. TEC’s offerings include in-depth research, detailed product information, and software selection services for any industry or company size.