21 CFR Part 11

The healthcare industry is increasing its use of computer systems, networking technology and use of electronic information systems to improve the efficiency of their operations. This drive to implement time, safety and cost-saving practices across the healthcare supply chain has created a need for enhanced security policies to protect electronic data.

The U.S. Food and Drug (FDA) Administration established 21 Code of Federal Regulations (CFR) Part 11, in 1997, to ensure the reliability and trustworthiness of electronic records and signatures. These regulations render e-signatures and records equivalent to paper records and handwritten signatures.

To be compliant with 21 CFR Part 11, an organization must develop, implement and enforce policies and procedures that specifically meet these requirements, including training and monitoring employees and deploying the appropriate technical infrastructure.

Companies must select solution providers with a proven record of meeting the FDA's regulations. TECSYS has a reputation of ensuring that its healthcare distribution customers meet with FDA approval, including 21 CFR Part 11, through proven solutions and methods of implementation.

TECSYS' EliteSeries healthcare software has the ability to secure and audit user, date, time and transaction detail information on key business data. The ability to secure and audit this information is the very cornerstone of the FDA's 21 CFR Part 11 regulation. Our Professional Services staff has vast amounts of healthcare distribution industry experience to help identify non-compliant areas of your business process and recommend solutions that fit you and your customers. Our Professional Services staff has the healthcare distribution industry experience to assist with your business processes and recommend solutions that fit you and your customers.

EliteSeries solutions enable healthcare enterprises to increase patient safety and reduce organizational risk, by complying with FDA regulations. A precious value as healthcare distribution continues to evolve under the watchful eye of government policies and standards.