MasterControl, Inc software

MasterControl`s Corrective Actions - CAPA Software Systems are designed for Automating the CAPA Process in any Enterprise. MasterControl`s CAPA Systems are designed by industry practitioners for automating the Corrective and Preventive Action (CAPA) process in any organization. A CAPA software system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated CAPA system reduces audit time and findings, and decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

Training software systems help companies to manage training tasks and related compliance requirements for less by automating and streamlining training processes from start to finish. MasterControl`s training software is a learning management system (LMS ) designed to help you integrate quality into your daily operations and facilitate compliance. The training system provides tools to help prevent quality problems and to show regulators that your quality standards and policies work. FDA rules, ISO standards, and other international regulations require training as an integral part of quality, so it`s crucial for you to choose the right training software.

Automate EBR Systems with MasterControl Electronic Batch Records Software Systems to Ensure Compliance with FDA CGMP Requirements. For pharmaceutical companies, accountability is an important component of quality management and FDA compliance. Electronic batch records systems, required by FDA Current Good Manufacturing Practice (CGMP) regulations, demonstrate accountability by providing proof of proper handling for every step in the production of each batch of a drug product. In addition, manufacturers that execute and document batch records electronically must comply with 21 CFR Part 11 requirements.

Is the `Beauty` of Your Food Safety Software Systems Only Skin Deep? MasterControl`s Food Safety Software Can Help You Maintain Quality Inside Out. The food safety landscape is changing rapidly. Public scrutiny has increased and stricter regulations such as the Food Safety Modernization Act (FSMA) are in place. In the past, your paper-based or hybrid system may have been good enough, but today`s regulatory environment demands more. It`s time to dig deeper into your internal quality and compliance processes. Will you benefit from food safety software systems? Is your existing food safety system efficient and effective? Can it handle new FSMA requirements?

Nonconformance Management Software Systems Integrates Nonconformance, CAPA, and other Quality Processes to Ensure Compliance with FDA Regulations and ISO Quality Standards. Nonconformance management software systems can make nonconformance management more efficient and compliance with FDA regulations and ISO standards easier. There are several references to the importance of material and product conformance to accepted specifications in the FDA`s Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. For example, it requires testing of components for conformity with all appropriate written specifications for purity, strength, and quality. CGMP also requires that laboratory controls include the establishment of appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, materials, and drug products conform to appropriate standards of identity, strength, quality, and purity. ( 21 CFR Part 211.84 ).

MasterControl Offers Bill of Materials (BOM) Software Systems to Automate Bill of Material / BOM Management. Each manufacturing company has its own unique production flow. But every company`s production is reliant on a bill of materials systems that can accurately identify and list the components required to produce a particular product at any given revision level. Bill of materials software can help companies simplify and standardize BOM management across departments to ensure dynamic and profitable manufacturing.

Deviation Management Software Systems by MasterControl Help in Automating and Integrating Deviations Management Processes FDA-Regulated and ISO-Quality Environments. In the FDA and ISO environments, the concept of quality is made tangible by written procedures and specifications, and any deviation from them must be documented and either justified or investigated. Such deviations may occur during sampling and testing, raw material and finished product acceptance, manufacturing and product distribution. The deviation management software system helps in conducting effective investigation and resolution of deviations which are an essential component of quality improvement and compliance.

Customer complaints management software helps regulated companies reduce complaint resolution time. Mistakes are inevitable. That’s not an excuse; it’s a fact of doing business. Unfortunately, in the life sciences and general manufacturing industries, mistakes can result in more than disgruntled customers and a barrage of complaints; they can result in serious safety issues, even death. With stakes this high, many regulated companies are automating their paper-based customer complaint management systems with electronic customer complaints management software to manage their complaint resolution process and maintain FDA and ISO compliance.

Electronic Device History Record (eDHR) Software Systems by MasterControl Automates Electronic Device History Records and Electronic Device Master Records (eDMR) to Comply with 21 CFR Part 820 and 21 CFR Part 11. The FDA`s Quality System Regulation (21 CFR Part 820) requires medical device manufacturers to establish and maintain device history records for each batch, lot, and unit they produce. The eDHR software is a compilation of all records pertaining to the production of a finished medical device. It entails extensive documentation that includes dates of manufacture, quantity manufactured and when they were released, acceptance records to show that the device was produced according to device master records (DMR), identification labeling, and device identification and lot numbers.

MasterControl Process Module in eProcess Automation Software Systems Help in Automating Business and Quality Processes to Improve Efficiency and Save Money Sustaining Compliance with ISO Environments. For oil and gas companies, forms whether paper or electronic ( eforms ), are necessary to perform data-capture activities. They are especially critical in gathering, securing, and processing information for quality processes necessary to conform to ISO international standards, such as audits, nonconformance, corrective/preventive actions, and customer complaints. To be effective, electronic forms-based processes should be flexible in meeting an organization`s needs. They should be efficient in getting input and approval from everyone involved and should allow collaboration among several people or departments.