Complying with U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry - SAP White Paper
Source: SAP Americas
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•Complying with U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry
Although the infrastructure and solutions provided by pharmaceutical, medical diagnostics and devices, and biotechnology companies are varied, life science companies have a common key business requirement: regulatory compliance. Given that almost all life sciences companies want to compete in the lucrative United States market, they all must then comply with U.S. FDA regulations – including those requirement that regulate the use of computerized systems that support good clinical, laboratory, and manufacturing practice. Another regulation, 21 CFR Part 11 Electronic Records; Electronic Signature; Final Rule, signaled FDA's awareness of the transition from paper-based, manual systems to computerized systems occurring within the life sciences industry.
Applying these requirements to the numerous computerized systems within life sciences companies translates into millions of dollars in project costs to validate these systems and significant annual costs to maintain them in a "validated state" for their productive lifetime.
The purpose of this document is to describe the functions and features of mySAP ERP that demonstrates technical compliance with U.S. FDA 21 CFR Part 11 Electronic Records; Electronic Signature; Final Rule and several international good manufacturing practice guidelines (GMP) having similar requirements. Click Here To Download:
•Complying with U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry
•Complying with U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry
Although the infrastructure and solutions provided by pharmaceutical, medical diagnostics and devices, and biotechnology companies are varied, life science companies have a common key business requirement: regulatory compliance. Given that almost all life sciences companies want to compete in the lucrative United States market, they all must then comply with U.S. FDA regulations – including those requirement that regulate the use of computerized systems that support good clinical, laboratory, and manufacturing practice. Another regulation, 21 CFR Part 11 Electronic Records; Electronic Signature; Final Rule, signaled FDA's awareness of the transition from paper-based, manual systems to computerized systems occurring within the life sciences industry.
Applying these requirements to the numerous computerized systems within life sciences companies translates into millions of dollars in project costs to validate these systems and significant annual costs to maintain them in a "validated state" for their productive lifetime.
The purpose of this document is to describe the functions and features of mySAP ERP that demonstrates technical compliance with U.S. FDA 21 CFR Part 11 Electronic Records; Electronic Signature; Final Rule and several international good manufacturing practice guidelines (GMP) having similar requirements. Click Here To Download:
•Complying with U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry
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