In August 1997, the regulation 21 CFR Part 11 "Electronic Records; Electronic Signatures" of the US Food and Drug Administration (FDA) came into effect. 21 CFR Part 11 (in short: Part 11) defines the FDA acceptance criteria for the use of electronic records and electronic signatures in place of paper records and handwritten signatures on paper. In this regard, electronic records and signatures must be as trustworthy, reliable and equivalent as conventional records. Siemens solutions (SIMATIC DCS and SIMATIC HMI/SCADA) fully meet the functional requirements for the use of electronic records and electronic signatures.

Electronic Records / Electronic Signatures

Requirements of 21 CFR Part 11

Presented by Uwe Mayer, Director GMP, Siemens AG, Vertical Market Management Pharma

Products and evidence

Presented by Uwe Mayer, Director GMP, Siemens AG, Vertical Market Management Pharma

Testimonials

Janssen Pharmaceutica

"Janssen Pharmaceutica has been using SIMATIC PCS 7 in combination with SIMATIC Batch in several applications in different plants. Our evaluation of the Siemens' DCS and the successful completion of Janssen's computerised system validation projects demonstrated the compliance of SIMATIC PCS 7 to the requirements of 21 CFR Part 11 (regarding Electronic Records/Electronic Signatures) for our applications."

Danny Wouters

Sr. Principal Engineer Automation Platform Solutions within World Wide Engineering & Technical Operations (WWE&TO)

Baxter

"Baxter has selected SIMATIC PCS 7, including SIMATIC Batch, for a recent very big automation project in Singapore.The full compliance to requirements for Electronic Records and Electronic Signatures as of US 21 CFR Part 11 is a mandatory criterion for Baxter and our evaluation of SIMATIC PCS 7 showed that it meets and exceeds our expections and standards."

Bernhard Baldaszti

Sr. Manager Engineering Services Projects & Support