FDA’s 21 CFR Part 11 is a regulatory framework guiding companies on creating and managing digital records and signatures. Facilitating regulatory oversight is the core focus of 21 CFR Part 11, while the driving force is to ease the cost and burden of maintaining paper records to satisfy regulators.

21 CFR part 11 compliance checklist helps evaluate a system’s CFR 21 part 11…

A general Corrective and Preventive Action (CAPA) process follows the Plan-Do-Check-Act (PDCA) cycle to resolve unexpected events. The first process will be the identification phase where you will identify non-conformities in your processes and determine what kind of problem you are looking at. Non-conformities may be determined during an internal or external audit, through customer…

GMP training is a requirement as it emphasizes employees performing all the tasks in accordance with GMP expectations and established procedures. GMP training is an essential requirement for pharmaceutical manufacturers as per 21 CFR 211.25 (a) – Personnel Qualifications. The GMP training is mandatory for both drug manufacturers and ingredient suppliers. Notably, GMP training and certification are considered a…

cGMP compliance assures consumers that the drugs are manufactured following the stipulated quality practices. As cGMP emphasizes quality control, the facilities are built as per a regulated design and manufacturing process. The FDA emphasizes the need for cGMP compliance to ensure the drugs that reach the market are safe for consumption. Notably, the recent cGMP regulations were published in 2016. cGMP compliance…

GxP stands for Good (G) and Practices(P) where x is a variable. Examples of GxP are GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices) etc. Comply with FDA Compliance and GxP Compliance.

GxP compliance ensures that the product under development meets requirements and is fit for the intended purpose. Applying relevant GxP process regulations is necessary for highly…

Compliance training is defined as employee training about law, regulations and company policies. Compliance training helps employees to reduce risk, maintain reputation and improve the workplace environment.

Compliance training is employee training authorized by regulation, legislation or policy that helps to reduce risk, maintain your reputation and improve the workplace environment to improve worker…