FDA 21 CFR Part 820 Regulation - Quality System

ISO 9000 is a set of quality management standards approved by the International Standards Organization (ISO) that defines a quality assurance program. It can be applied to all kinds of organizations in a variety of areas. Adherence is accomplished through an application process for ISO 9000 certification in company standards for inspecting production processes, updating records, maintaining equipment, training employees, and handling customer relations. The standards require that a basic quality system be in place to ensure that the company has the capabilities and systems to provide its customers with quality products and services. It is not a standard for ensuring a product or service is of quality; rather, it attests to the process of production, and how it will be managed and reviewed.

Benefits

Some of the perceived - and actual - benefits experienced by certified companies include:

• Well defined and documented procedures improve the consistency of output.
• Documented procedures are easier for new employees to follow.
• Reduction and variability resulting from both documentation and the use of statistical techniques to monitor the system.
• Using their registration to help develop and expand business, particularly those areas where registration is a prerequisite for doing business.
• Reduction or elimination of customer audits.
• Increased profitability/reduced costs.
• Improved communications, both internal and external.
• Greater awareness of quality by employees, accompanied by enhanced pride in their jobs and contribution to the company's quality system.
• Supplying training to all personnel.
• Ability to remain/become competitive in the markets.
• Realization that meeting the requirements is not rocket science but common sense.
• Elimination of redundancy.
• Quality is constantly measured.
• Customer satisfaction, and more importantly, customer loyalty, grows.
• Procedures ensure corrective action is taken whenever defects occur.
• Defect rates decrease.
• Defects are caught earlier and are corrected at a lower cost.
• Defining procedures identifies current practices that are obsolete or inefficient.
• Organizations retain or increase market share, increasing sales or revenues.

The Challenge

The following issues may impact a company in its registration efforts:

• Limited resources ­ when asked, most companies will normally identify money, personnel, and time as their most problematic resources.
• Lack of analysis tools for managing the portfolio.
• Overlapping of responsibilities - each employee most likely wears a number of hats, thus limiting the amount of responsibility that can be placed on each person. The challenge for the company becomes finding ways not to overburden its employees.
• Difficulty in adoption and standardization of quality management initiatives across the organization.
• Time - the company may be pressured by customers to implement a quality management system within a certain time frame or potentially lose their business.
• Supporting cultural change throughout implementation.
• Unable to analyze interdependencies across different projects.
• Implementing an effective team structure with management support.
• And many others.

All of these are significant challenges. However, the implementation and registration of a management system helps an organization achieve continuous performance improvement.

To deal with all these challenges, an integrated and automated management system can certainly be of great help.

SoftExpert Excellence Suite is a web-based management system, designed to help you to meet ISO requirements easily and effortlessly.

SoftExpert Excellence Suite provides organizational efficiency, process control, and flexibility to help simplify the tasks involved in managing data and information. It will also help your organization make better decisions in managing the content and process that drive your business.

 

Each SoftExpert Excellence Suite module meets key regulatory requirements, as shown below:

Module	Compliance and Requirements
SE Action	Manages the entire process by: Recording real or potential nonconformities and their causes. Offering the planning and implementation actions required to eliminate detected nonconformities. Authorizing use, release or acceptance under the concession of the nonconforming product by a relevant authority and, where applicable, by the customer. Planning and taking action to preclude its original intended use or application of nonconforming product. Planning and taking action appropriate for the effects, or potential effects, of the nonconformity when a nonconforming product is detected after delivery or use has started. Reviewing real and potential nonconformities, including customer complaints. Determining the causes of real and potential nonconformities. Evaluating the need for action to ensure that nonconformities do not reoccur. Determining and implementing the action needed to eliminate real and potential nonconformities. Recording the results of the action taken, including: corrective, preventive or predictive. Reviewing the effectiveness of the corrective and preventive action taken.
SE Audit	Manages the entire process by: Planning and executing first, second and third part audits. Programming audits, taking into consideration the scope, status and importance of the processes and/or areas to be audited. Defining the criteria, methods, responsibilities and requirements to be audited. Selecting auditors, according to their skills, ensuring that they will not audit their own work. Maintenance of records: Audits and their results. Evidence ocurrences¹. Disposition action and CAPA¹. Cause analysis¹. Follow-up activities¹. Verification of the actions taken¹.
SE Asset **	Manages the entire process by: Determining the infrastructure needed to achieve conformity with product requirements. Determining the work environment needed to achieve conformity with product requirements.
SE BI	Helps identify, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the management system.
SE Calibration **	Manages the entire process by: Performing calibration and/or verification, or both, at specified intervals, or prior to use, based on measurement standards. Tracing measurement standards. Adjusting or re-adjusting as necessary. Performing identification in order to determine calibration status Safeguarding the system from adjustments that would invalidate the measurement result.  Maintenance of records: Validity of the previous measuring results. Results of calibration and verification. Evidence ocurrences¹. Disposition action and CAPA appropriate for equipment and any product affected¹. Cause analysis¹. Follow-up activities¹. Verification of the actions taken¹.
SE Competence *	Manages the entire process by: Determining the necessary competence for the personnel performing work affecting conformity with product requirements. Evaluating the effectiveness of the actions taken. Making users aware of the relevance and importance of their activities and how they help achieve the objectives established by the organization. Maintaining the appropriate records of education, skills and experience.
SE Document	Manages the entire process by: Elaborating, reviewing and approving documents for adequacy prior to issue. Reviewing and updating as necessary and re-approving documents. Identifying, storing, protecting, retrieving, retaining and disposing of records. Ensures that: Changes and the current revision status of documents are identified. Relevant versions of applicable documents are available. Documents and records remain legible and readily identifiable. Documents of external origin determined by the organization are identified and their distribution controlled. Prevents the unintended use of obsolete documents, and suitably identifies them if they are retained for any purpose.
SE Inspection **	Ensures: That the purchased product conforms to the specified purchase requirements. That the type and extent of control applied to the supplier and purchased product will be dependent on the effect the purchased product has on subsequent product development or the final product. The maintenance of records: The results of supplier evaluations. The results of inspections conducted on products purchased prior to use. Any necessary actions¹.
SE Maintenance **	Manages the entire process by: Maintaining and managing the infrastructure needed to achieve conformity with product requirements. Maintaining and manages the work environment needed to achieve conformity with product requirements.
SE PDM **	Automates the definition of product characteristics so that your call can then be checked at the appropriate stages of the product development process.
SE Performance	Manages the entire process by: Defining objectives, indicators, targets and action plans (planning) to follow the policy established by the organization. Deploying objectives, indicators, targets and action plans in the relevant functions and levels within the organization. Defining the appropriate methods to monitor and, where applicable, measure objectives, indicators, targets, action plans and process established by the organization.
SE Process	Manages the entire process by: Defining the processes needed and their application throughout the organization. Planning and developing the processes needed for product development. Determining the sequence and interaction between these processes. Determining the criteria and methods required to ensure that both the operation and control of these processes are effective. Defining the resources and information necessary to support the operation and monitoring of these processes. Defining the monitoring and measurement points, where applicable, and analyzes these processes. Implementing the actions necessary to achieve planned results and continually improve these processes.
SE Project **	Manages the entire design and development process, including: Planning and control. Determination of the appropriate stages. Record review, verification and validation appropriate to each stage. Definition of responsibilities and authorities. Determination of inputs, outputs and records needed. Verification. Validation. Control of changes.
SE Request	Manages the entire identification process through: Requirements specified by the customer or others with interested parties (shareholders, employees, suppliers and the community). Requirements not stated by the customer but necessary for specified or intended use, where known. Statutory and regulatory requirements applicable to the product and the process. Any additional requirements considered necessary by the organization with aims of enhancing customer satisfaction.
SE Risk *	Helps the organization manage the risks associated with its organizational environment and related changes.
SE SPC **	Manages the entire process by: Determining the monitoring and measuring equipment needed to provide evidence of product conformity with determined requirements. Ensuring that monitoring and measurement can be performed and are done so in a manner that is consistent with the monitoring and measurement requirements. Monitoring and measurement the characteristics of the product at appropriate stages of the product development processes in order to verify that their requirements have been met in accordance with the planned arrangements.
SE Training *	Manages the entire process by: Providing training or taking other actions to achieve the necessary competence. Evaluating the effectiveness of the training. Raising user awareness as to the relevance of the assigned activities and how they help achieve the objectives established by the organization. Maintaining the appropriate records of training.

* Premium Package
** SE Suite Package
¹ Activities performed through the interface with SE Action