The right pharmaceutical quality assurance software plan can spell out success for FDA-regulated companies seeking the peace of mind sustained regulatory compliance can bring.
While the FDA encourages modernization and harmonization with other quality system requirements, the agency is also required to ensure that pharmaceutical quality assurance software includes compliance with CGMPs (21 CFR Parts 210, 211) and electronic system requirements (21 CFR Part 11).
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The Q&A session based on the FDA's Quality Control Systems Approach to Pharmaceutical cGMPs addresses topics related to the Guidance for Industry Pharmaceutical Quality Control Systems Approach to cGMP Regulations and answers the following questions:
MasterControl Inc. is leading global provider of web-based process and document management software solutions and helps regulated companies sustain regulatory compliance with an unmatched combination of industry experience and innovation.
MasterControl's pharmaceutical quality assurance software system offers complete solutions to solve the challenges of regulatory compliance. Knowledgeable MasterControl representatives can help each company decide on the specific software that is right for them, and can then configure a complete QA software plan that meets their unique needs.
The solutions that lie within any pharmaceutical quality assurance software plan include the latest technology and the organizational know-how to make any FDA regulated company's day-to-day processes more efficient and effective. MasterControl's Pharmaceutical Quality Control & Assurance Software include the following:
For pharmaceutical companies, MasterControl can provide an array of web-based pharmaceutical quality assurance software systems that automate, streamline and funnel quality processes, quality documentation and CAPA controls into a fast and effective quality management system. The system includes the control of quality assurance (QA) processes such as audits, deviations, nonconformance, change control, CAPA, etc. To learn more about automating a Total Quality Management (TQM) system please feel free to contact a MasterControl representative.
MasterControl, Inc., a developer of software solutions, provides more than the technology for pharmaceutical quality control. MasterControl's solutions address the needs of all departments within ISO-standardized and FDA-regulated companies from engineering to quality, and from development to regulatory. To learn more about MasterControl's pharmaceutical quality control software systems for faster speed-to-market and surer compliance, please feel free to contact a MasterControl representative.