Displaying 1 - 10 of 201 results for DocuLex; compliance software (0.044 seconds)
Product Safety Case Study Compliance Testing and Certification
Moore Industries believes it is of vital importance to have third-party SIS evaluation for plant safety provided by a company with global coverage and reputation....
Achieving 21 CFR Part 11 Compliance Using CENTUM VP
This technical white paper will discuss Yokogawa's CENTUM VP DCS (Distributed Control System) product, hereafter referred to as "CENTUM VP", and the extent of its...
Establishing Compliance of Batch SCADA Systems with FDA cGMP 21 CFR Part 11
FDA enforcement of a 1997 cGMP regulation, 21 CFR Part 11, for electronic records and signatures, is imminent. Compliance policy Guidelines were issued May 1999 to...
Compliance Testing and Certification
Moore Industries believes it is of vital importance to have third-party SIS evaluation for plant safety provided by a company with global coverage and reputation....
Benefits of Advanced Engineering Methodologies for the Design and Support of Batch Projects in the Pharmaceutical Industry
A cost breakdown of any major batch project reveals that the a major part of the engineering effort is spent on the coding of the logic and sequences. This applies...
21CFR11 Compliance and Automated Manufacturing
21CFR11 took effect in August 1997 with little observed regulatory activity. However, that has changed and increasing numbers of FDA warning letters are being...
Planning and Developing Effective Emergency Mass Notification Strategies for Hazardous Industrial Applications in the Post 9/11 Era.
Emergency mass notification for hazardous industrial processing operations has traditionally focused on audible and visual signaling devices such as sirens, horns,...
M2E (Machine to Enterprise) Integration Has Never Been Easier
Are you taking advantage of it?</p> <p>Over the years, we've had sensor upgrades for process measurement, improved controllers for automation, HMI/SCADA...
Impact of Batch Software Upgrades on Validated Batch Applications
Batch software upgrades on validated batch applications raises many issues. This paper talks about guidelines on how much revalidation evidence is needed to meet...
GAMP4 guidelines concerning the use of process simulation software
This paper discusses GAMP4 guidelines concerning the use of process simulation software, the impact of system testing and qualification of the software on project...
