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Efficient Software Testing for a Regulated Environment 23 Jul 2012 | 10:13 pm
Testing, as with all validation activities, is not only performed to demonstrate regulatory compliance but to ensure that the system operates correctly. The level of testing performed should be depen...
Engineering with an S88 Approach (Part 3) 17 Jul 2012 | 02:20 am
S88 and the Functional Specification both play vital roles in conceptual and preliminary design and the Functional Specification actually produces a brand new deliverable to the first design altogethe...
Engineering with an S88 Approach (Part 2) 10 Jul 2012 | 03:46 pm
The S88 approach was used in designing a multi-product plant of biotech manufacturing where modularity, flexibility, cGMP compliance, and time to market were the main goals. Learn how it is used throu...
Top Tips for Cleaning Method Development 29 Jun 2012 | 09:20 pm
Cleaning validation should only start once there is a well-developed, capable, and consistent cleaning process in place along with agreed limits, validated sampling and detection methods, and a docum...
Electronic Records – CSV FDA Warning Letters 26 Jun 2012 | 05:46 pm
In addition, we remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-da...
Quality Improvement in Pharmaceutical Manufacturing 18 Jun 2012 | 10:10 pm
Pharmaceutical and medical products quality control has taken a backseat to innovative science and compelling marketing, as poor quality and related compliance issues have cost the pharmaceutical indu...
EU Annex 11 – Computer System Inventory 12 Jun 2012 | 04:36 pm
EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines Annex 11 for computerised systems includes the requirement for the regulated company to maintain an up to date listing of relevant syst...
Challenges in Pharmaceutical Product Life Cycle Management 5 Jun 2012 | 05:29 pm
Challenges in Pharmaceutical Product Life Cycle Management All products and services have certain life cycles. The life cycle refers to the period from the product’s first launch into the market until...
Challenges in Pharmaceutical Product Life Cycle Management 4 Jun 2012 | 11:28 pm
All products and services have certain life cycles. The life cycle refers to the period from the product’s first launch into the market until its final withdrawal. During this period significant chang...
Computer System Validation – Periodic Review 29 May 2012 | 07:47 pm
Both the FDA and EU GMP’s detail the requirement for demonstrating that a computer system remains in a validated state throughout its operating history. FDA 21 CFR 211.68(b) States: “Input to and ou...
