Our Software application is fully compliance with 21 CFR Part 11 requirements. We provide full validation package and support needed for compliance with 21 CFR Part 11 requirements.
We provide solutions to help our customers to design processes that complies with FDA QSR (21CFR 820, 21CFR211) without sacrificing the productivity. Following are some of the highlights of our solutions.
Sec. 820.20 Management responsibility.Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.
We provide solution for document management system to establish quality system procedures and instructions
Sec. 820.22 Quality audit.Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.
Our audit system makes it easy to manage the audits and keep records that will help comply with the section 820.22
Sec. 820.25 Personnel- Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented
Our training system helps assignment of the training items and documentation of completed trainings.
Sec. 820.100 Corrective and preventive action.(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.
OuCAPA systemr helps establish and maintain procedures for implementing corrective and preventive action.