Suhail MughalContrasting frameworks: 21 CFR Part 11 vs. ISO 27001We often observe a blurring of lines when it comes to distinguishing between 21 CFR Part 11 and ISO 27001 compliance in the industry…Nov 8, 2023
MSB21 CFR Part 11 and Good Documentation Practices in Pharmaceutical IndustriesIt has been said that in the pharmaceutical industry, “If it isn’t documented, it didn’t happen.”Sep 25, 2019
Kristof HorvathinIntland Software blogTitle 21 CFR Part 11: FDA Requirements ExplainedThe FDA’s Title 21 CFR Part 11 regulation governs the way life sciences organizations are permitted to use electronic records and…Nov 11, 2020Nov 11, 2020
PERFEQTACapturing Data Electronically in Clinical Research with PERFEQTAIt seems as though every week we are coming up with a new use for our fully flexible SaaS platform, PERFEQTA. Perhaps, I will have to start…Mar 21, 2022Mar 21, 2022
Suhail MughalContrasting frameworks: 21 CFR Part 11 vs. ISO 27001We often observe a blurring of lines when it comes to distinguishing between 21 CFR Part 11 and ISO 27001 compliance in the industry…Nov 8, 2023
MSB21 CFR Part 11 and Good Documentation Practices in Pharmaceutical IndustriesIt has been said that in the pharmaceutical industry, “If it isn’t documented, it didn’t happen.”Sep 25, 2019
Kristof HorvathinIntland Software blogTitle 21 CFR Part 11: FDA Requirements ExplainedThe FDA’s Title 21 CFR Part 11 regulation governs the way life sciences organizations are permitted to use electronic records and…Nov 11, 2020
PERFEQTACapturing Data Electronically in Clinical Research with PERFEQTAIt seems as though every week we are coming up with a new use for our fully flexible SaaS platform, PERFEQTA. Perhaps, I will have to start…Mar 21, 2022
Don Weobong21 CFR Part 11 Compliance: Electronic Signatures and Your LMS21 CFR Part 11 Compliance: Electronic…Complying with the FDA’s 21 CFR Part 11 can be pretty challenging. In large part, that is because the government’s requirements seem…Nov 20, 2020
Terri Hanson MeadinTerri Hanson MeadSaaS System Validation: Validating for Intended UseI’ve consulted with life sciences companies on system selection, system implementation, and computer validation for nearly 14 years (and…Apr 23, 2019
Terri Hanson MeadinTerri Hanson MeadValidating a SaaS SolutionWe need to start with a base assumption and that is: the life sciences company is responsible for validating a software solution for its…Mar 2, 20181
