Regulation 21 CFR Part 820

Transcription

1 Regulation 21 CFR Part 820

2 Regulation 21 CFR Part 820 Medical Device manufacturers have the ability to produce goods that can improve the quality of life, and at times, even save them. With this capacity, however, comes the responsibility to comply with government regulations, and to consistently manufacture and distribute safe and reliable products. In the 21st century, the impact of FDA inspections and fines levied for noncompliance and high-profile product recalls are driving a powerful reaction among Medical Device organizations. The immediate challenge lies in proactively eliminating risk. Today, compliance with Good Manufacturing Practices (GMP) in a global environment means understanding the increasingly complex industry regulations. Failing to adhere to these regulations can erode shareholder confidence and damage brand equity. As a result, regulated companies seek to implement enterprise-wide compliance and quality management solutions that can quickly address customer and regulatory issues consistent with worldwide requirements, while simultaneously being leveraged to enhance business processes. 21 CFR Part 820, also known as the Quality System Regulation QSR outlines Current Good Manufacturing Practice CGMP regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe and effective. Medical device manufacturers undergo FDA inspections to ensure QSR compliance. Pilgrim Software 21 CFR Part 820 Reference Chart Subpart Section (s) B Audit Management, CAPA Management Training Management D Document Management E Audit Management, Document Management, Supplier Quality Management G Document Management, Training Management, Equipment Management Equipment Management H Document Management, CAPA Management, Supplier Quality Management I CAPA Management J CAPA Management M SmartSolve Complaints Management 2

3 (Subpart B Section )* Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a re-audit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and re-audits shall be documented. (Subpart B Section )* Each manufacturer must have sufficient personnel with the necessary background, training, and experience. It must have established procedures for identifying training needs and ensuring that employees are adequately trained to perform their jobs. Training should be documented. (Subpart D Section a)* Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use. Pilgrim s Training Management application maintains employee skills and training history to ensure that employees are adequately trained to perform their jobs. Training Management maintains training and qualification history for each employee. Managers can query and report on employee qualifications to ensure that each person is qualified to ensure competent performance of his assigned job functions. Training Management provides notifications to keep managers informed of upcoming employee training needs. Pilgrim s Equipment Management solution maintains equipment records and calibration procedures. Equipment Management provides a calibration schedule with automatic electronic notifications to ensure that calibration is performed in a timely manner. Pilgrim s Document Management solution s approval and distribution features ensure that approvals occur in a timely manner and that documents are available to employees who need them. Each document approval record contains the approval date, approver comments and approver signatures. This data is maintained in the document s history for each build of every document revision. Document Management limits end user document viewing to only current and applicable documents. Obsolete and in-works (draft) documents are automatically removed from end user access. Document Management is a web-based application, which facilitates document access for all employees. 3

4 (Subpart D Section b)* Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective. (Subpart E Section a)* to ensure that all purchased or otherwise received product and services conform to specified requirements. Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall: (evaluate suppliers, establish and maintain supplier records, etc.) (Subpart G Section )* Requirements in Subpart G include further requirements for trained personnel, the establishment of SOPs, equipment inspection and maintenance, and other process control requirements. Document Management s change management capabilities track changes from their initial request to their final implementation. Each change record includes the information described in section , including change approval and notification workflow, change description, identification of affected documents, signatures, approval dates and effective date of the change. Change owners are automatically provided the names and or functions/organization of the original document reviewer to be used in the change review/approval process. Supplier audits and evaluations are managed within Pilgrim s Audit Management application. Audit Management maintains all relevant supplier audit records. Audit Management s features are available for internal, supplier and third party audits. This includes the capability for re-audit, follow-up investigations through integration with CAPA Management and audit reporting. In addition, Pilgrim s Supplier Quality Management application maintains receiving inspection procedures and the corresponding inspection for purchased products. Document Management manages any type of SOP created within an organization. This includes the approval, release, training, distribution and obsolescence of each SOP. Training Management manages personnel training and history. Pilgrim s Equipment Management solution maintains equipment schedules and records. 4

5 (Subpart G Section a)* to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented. (Subpart G Section b)* Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device s quality. These activities shall be documented. This section further defines requirements for calibration standards and calibration records. (Subpart H Section a)* for acceptance activities. Acceptance activities include inspections, tests, or other verification activities. (Subpart H Section b)* for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented. Pilgrim s Equipment Management allows for the establishment of procedures to calibrate, inspect, check and otherwise maintain measuring equipment. All relevant equipment management activities may be documented within the system. Pilgrim s Equipment Management s procedure function allows for the establishment of calibration limits and the provisions for remedial action for each piece of equipment. Calibration history includes traceability to national requirements and the documentation and maintenance of calibration records. Equipment identification, the individual performing calibration, calibration date and the expected next calibration dates are also documented in the calibration record. Pilgrim s Document Management manages any type of procedure created within an organization. This includes the approval, release, training, distribution and obsolescence of the procedure. In the event that a product does not meet inspection specifications, Pilgrim s CAPA Management manages the nonconformance and corrective action process. Pilgrim s Supplier Quality Management application manages receiving acceptance activities such as inspection and testing. Acceptance or rejection is documented and tied to each supplier s performance and rating record. 5

6 (Subpart I Section )* to control product that does not conform to specified requirements. Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. Each manufacturer shall establish and maintain procedures for rework,etc. (Subpart J Section a)* for implementing corrective and preventive action. The procedures shall include requirements for: (analysis, investigation, corrective and preventive actions, change implementation, notifications, management review and documentation). (Subpart M Section )* Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not limited to, the records required by Each manufacturer shall ensure that the QSR is prepared and approved in accordance with Pilgrim s CAPA Management helps identify the occurrence of nonconformances, incidents, discrepancies, out-of-specifications or any other quality issue. Once an issue is identified, CAPA Management manages the workflow and notifications needed to resolve the problem. This includes workflow and notifications for rework activities. Approved rework work instructions are linked to the rework disposition through builtin integration with Document Management. Pilgrim s CAPA Management application is a closedloop CAPA management system that allows users in any department to initiate a corrective and preventive action process to address and resolve an issue. The application is extremely flexible and allows for the definition of one or more steps of Corrections, Analysis, Detailed Root Cause investigation, CA and PA documentation, approvals of proposed changes, implement and track the approved changes and finally effectiveness reviews. By facilitating an effective CAPA process, CAPA Management helps to resolve issues quickly and prevent recurrence ensuring compliance with industry and regulatory requirements. SmartSolve maintains a centralized, 21 CFR Part 11 compliant system of all quality records including audit records, documents and document records, training history, CAPA workflows and history, equipment records and supplier history. Users are provided quick and easy access to quality records through standard searches, reports and queries. 6

7 (Subpart M Section )* Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary, etc. Pilgrim s Complaints Management s configurable, easy-to-use Web form captures complaint information from the entire organization, including complaints from off-site personnel, such as field services representatives. Complaints Management allows for complaint review and identify the need for detailed investigations. Furthermore, Complaints Management streamlines the submission and tracking of reports to the appropriate regulatory body. The application s standard automated decision trees, which are highly configurable, assist in medical device reportability reviews for the FDA and for other regulatory agencies in the world. The scope of today s Life Science companies is becoming increasingly global, both in the demand for, and the sale of life-enhancing products. These organizations must be able to support manufacturing and distribution throughout the world while addressing the potential operational risks, as well as overcoming the quality, safety and revenue pressures inherent in the industry. The world s leading enterprise compliance and quality management companies, like Pilgrim Software, are lowering those risks and strengthening the profitability of organizations, through enterprise-wide, automated solutions. Manufacturers then are able to dedicate their resources to designing higher quality products that will directly benefit patients quality of life. 7

8 ABOUT PILGRIM SOFTWARE Pilgrim Software, Inc. is a world-leading provider of Enterprise Compliance and Quality Management (ECQM) solutions for highly regulated industries. Pilgrim has pioneered effective, integrated software solutions for the Life Science and FDAregulated industries, as well as manufacturers in the automotive, aerospace and defense, and other regulated manufacturing industries. Pilgrim s reputation for excellence in innovation has attracted an impressive portfolio of global customers. More than a half-million end-users employ Pilgrim products every day to meet the diverse challenges of the world s highly competitive marketplace. Pilgrim s fully Web-based, integrated solutions help businesses centrally manage domestic and international operations to ensure product safety and compliance, reduce manufacturing costs and improve customer satisfaction. United States Headquarters 2807 W. Busch Blvd. Tampa, FL Tel. (813) Fax (813) sales@pilgrimsoftware.com European Headquarters Hilversum The Netherlands Tel. +31 (0) Fax +31 (0) emea@pilgrimsoftware.com 2010 Pilgrim Software, Inc. All Rights Reserved.