Regulatory
ISO 9000 requirements stipulate the improvement of quality processes. For ISO-compliant and other regulated companies, forms are necessary to gather, capture, and process the quality data that need to be reported and analyzed as part of compliance. ISO forms, especially electronic forms, are valuable in integrating various quality processes and automating those processes.
Select all the resources you’re interested in downloading
For regulated companies, forms are necessary to perform data-capture activities on a regular basis. ISO forms are especially critical in gathering, securing, and processing information for quality processes necessary to conform to ISO quality standards, including processes such as audit, nonconformance, corrective and preventive action (CAPA), customer complaint, and change control. Investigations, corrections, and prevention are regulatory necessities that ISO auditors consider singularly critical, and electronic ISO forms can be used to streamline the data and information used in a number of these quality processes.
Regulated companies commonly use electronic ISO forms for the following quality processes:
Automate, streamline, and effectively manage the audit process, from scheduling and planning through execution and completion.
Integrate the CAPA process with other quality processes compliant to ISO 9000, and launch CAPA forms directly from nonconformance reports and other forms.
Streamline the entire change control process, and leverage customizable reports that provide the real-time status of change control tasks and the entire QMS compliant to ISO 9000.
Automate the customer complaint-handling process, and reduce the lifecycle from submission to resolution according to ISO 9000 regulations.
Automate, streamline, and effectively manage the process for identifying, evaluating, reviewing, and handling nonconforming materials, components, parts, and finished products.
Electronic ISO forms like those offered by MasterControl make data entry, collaboration, routing, approval, and archiving achievable in a fraction of the time it takes many companies that currently manage ISO 9000 forms and ISO 9001 documentation.
MasterControl provides validation tools and services within electronic ISO forms to make validation far less time-intensive.
MasterControl QMS solutions:
Provide forms that can be integrated with document-based processes in one secure repository.
Easily control essential ISO 9000 forms and ISO 9001 documentation.
Automate routing, notification, escalation, and approval of any forms-based process.
Reduce manual data entry and avoid human-error mistakes common in manual data entry.
Provide time-stamped audit trails, robust reporting, and e-signature capabilities.
Facilitate connections between essential quality processes, such as audits and CAPAs.
To be effective, electronic forms-based processes must efficiently obtain input and approval from everyone involved, and they should allow for collaboration among several people, departments, and locations. The following best practices will help those who build electronic ISO forms for compliance purposes or those whose work involves forms-based processes.
Applying these electronic ISO form best practices will better position regulated companies to continuously improve quality processes, improve customer satisfaction, and maintain regulatory compliance.
Keep forms as simple as possible by using standard fonts, etc.
Break the form up into sections according to data type.
Use the form as part of a process rather than as the process itself.
Be agile in iteration: Make a plan, execute it, and revise the design as needed.
Be conscientious about gathering user requirements to provide greater user value.
Include user testing to identify issues not anticipated by the form designer.
Ensure software-specific training is provided to all users.
MasterControl automates the control of all the documentation essential for compliance with the ISO 9000 series of standards, with solutions that streamline and integrate critical quality processes. In addition to ISO forms-related control solutions, MasterControl also offers implementation, validation, training, and project management services. For more than 25 years, MasterControl has helped regulated companies around the world transition from manual paper-based processes to electronic operations designed to bring compliant products and services to market sooner.
MasterControl solutions are used by the most trusted leaders in life sciences and manufacturing industries. Since 2009, the U.S. Food and Drug Administration (FDA) has been using a variety of MasterControl’s Quality Excellence™ solutions to improve the quality processes of the Office of Regulatory Affairs (ORA) and the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER). In addition, MasterControl reiterated its commitment to continued leadership in the field of quality and compliance software when it became one of the first companies in the world to successfully complete a certification audit to the ISO 9001:2015 standard.
To learn more about MasterControl's software systems, please contact a MasterControl representative.
