Dietary Supplements Software Systems
Quality Management Software for Dietary Supplement Companies Automates Processes Essential to Good Manufacturing Practices
In June 2007, the FDA issued the Current Good Manufacturing Practice (CGMP) requirements for Dietary Supplements (21 CFR Part 111). In essence, the ruling requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations.
Companies that manufacture, package, label, or hold dietary supplements are required to follow the GMP rule.
Schiff Nutrition International (4:36)
Creating a Paperless Process Using MasterControl (3:38)
Using MasterControl for FDA Compliance (3:53)
Integrated Dietary Supplements Software Solutions for Manufacturers of Dietary Supplements
As a manufacturer of dietary supplements, you may be looking for integrated solutions for document control or document management, training and CAPA that are reasonably priced and assure compliance with 21 CFR Part 111. MasterControl can provide these solutions, and all of the solutions you need to establish procedures for quality control operations, effectively handle deviations (planned and unplanned), keep written records of customer complaints related to the Current Good Manufacturing Practice (CGMP) requirements, etc.
Dietary Supplements System Quality Challenges
To ensure that the good manufacturing practices specified by the FDA are met, a company involved in the manufacturing, packaging, labeling, or holding of dietary supplements must address a number of challenges, including:
- Inefficient Quality System: Establishing good manufacturing practices and maintaining records for manufacturing operations, customer complaints, corrective actions, deviations and nonconformances, employee competencies, etc., can be extremely challenging without an automated quality control system that integrates and documents the various quality processes.
- Disconnected Processes: Quality processes that are not connected to one another can lead to delays and poor results. For example, a corrective action system that's not connected to the rest of the quality system may produce an unreliable root cause investigation due to inadequate information. In contrast, a corrective action system that is connected to detailed customer complaint and product investigation records ensures an effective corrective action process.
- Unprepared for a GMP Inspection by the FDA: During an FDA inspection, companies must be able to quickly access their records in order to prove that, for example, customer complaints regarding a product defect were properly investigated. As part of this process, companies must also be able to show that the necessary corrective action(s) were taken, the relevant SOPs were updated, employees affected by the updated SOPs were retrained, etc. Without a unified quality control system for automating and tracking the appropriate actions, it can be very difficult to quickly access records or, worse, access them at all.
For More Information on Dietary Supplements Software Systems
For more information about the solutions provided by MasterControl for manufacturers of dietary supplements, please feel free to contact a MasterControl representative.
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