The following are some of the key requirements of 21 CFR Parts 1270-1271 and how MasterControl addresses them:
|21 CFR Part 1270, 21 CFR Part 1271 Regulations||MasterControl Software Solutions Features|
Part 1270.31 ( Subpart C): There shall be written procedures prepared and followed for all significant steps.
Part 1270.33 (Subpart C): Records shall be maintained concurrently with the performance of each significant step "The records shall identify the person performing the work, the dates of the various entries, and shall be detailed as necessary to provide a complete history."
Part 1271.47 (Subpart C): Procedures for all steps in testing, screening, and determining donor eligibility must be established and maintained. Establish and maintain means define, document, implement, follow, review, and as needed, revise on an ongoing basis to ensure 21 CFR Part 1271 compliance.
Part 1271.200 (Subpart D): (e) Document and maintain records of the use of each piece of equipment, including the identification of each HCT/P manufactured with that equipment.
Part 1271.270 (Subpart D): (b) You must establish and maintain a records management system relating to core CGTP requirements to ensure compliance with 21 CFR Part 1271 "Records pertaining to a particular HCT/P must be maintained in such a way as to facilitate review of the HCT/Ps history before making it available for distribution."
MasterControl Documents, the building block within the MasterControl quality suite, automates and streamlines routing, approval, escalation, and revision control. Provides advanced analytics and reporting capability for a real-time view of the system which helps in monitor the 21 CFR Part 1271 regulated processes. Provides secure, time-stamped audit trail of all changes, including the identity of the person making the change, when, and why.
MasterControl Forms automates, streamlines, and effectively manages any forms-based process in the recovery, donor screening, donor testing, processing, and other critical steps. Forms created in Microsoft Word, Excel, or PowerPoint can be converted to PDF as is, so end users will see the same form and won't need new training. A company may also improve existing forms according to 21 CFR Part 1271 regulations or design new ones to suit its needs.
There shall be written procedures prepared and followed for all significant steps in the infectious disease testing process. Any deviation from the written procedures shall be recorded and justified.
MasterControl Deviations automates data collection, routing, follow-up, and escalation of deviation cases. Tracks all routing information and data entered into the electronic form, allowing the deviation owner to identify bottlenecks and understand the sequence of events during processing which ultimately leads to 21 CFR Part 1271 compliance.
An establishment covered by these regulations...shall permit an authorized inspector of the FDA to make...an inspection.
Part 1271.400 (Subpart F): If you are an establishment that manufactures HCT/Ps...you must permit the FDA to inspect any manufacturing location at any reasonable time and in a reasonable manner to determine compliance...
The MasterControl suite helps ensure Good Tissue Practice (GTP) compliance with 21 CFR Part 1271 by optimizing processes and keeping the quality system always ready for FDA inspections. All relevant documents and records will be stored in a centralized, Web-based repository, making it easy to track and retrieve them during an inspection.
Tissue establishments may also perform internal audits to boost inspection readiness and to ensure all processes are accordign to 21 CFR Part 1271 regulations. MasterControl Audit automates, streamlines, and effectively manages the audit process. Provides advanced tracking capability, from scheduling and planning to execution and completion. Offers best practice forms and automates scheduling of all recurring audit-related activities.
(a) Establishments that perform any step in the manufacture of HCT/Ps must establish and maintain a quality program.
(b) Functions of the quality program include... Ensuring that appropriate corrective actions relating to core CGTP requirements, including re-audits of deficiencies, are taken and documented, as necessary.
(c) Quality audit must be periodically performed.
(d) Validate computer software for intended use...if you rely upon the software to comply with core CGTP requirements...
The MasterControl suite can serve as the foundation for the entire quality system to help ensure Good Tissue Practice (GTP) compliance with 21 CFR Part 1271. It automates all quality-related tasks such as routing, tracking, escalation, review, and approval of documents and forms. Automation helps sustain compliance by simplifying the compliance environment, standardizing and streamlining processes, and promoting efficiency. Provides a single repository for all quality documentation, making search and retrieval easy during inspections and audits.
MasterControl CAPA integrates corrective action process with other quality processes. A CAPA form can be launched directly from another form (i.e., a nonconformance report). Automatically enters relevant data into a CAPA form, reducing data entry and eliminating errors from manual transfer of information according to 21 CFR Part 1271 regulations. Provides customizable reporting capabilities to help managers monitor entire quality management life cycle.
MasterControl Audit automates, streamlines, and effectively manages the audit process. Provides advanced tracking capability, offers best-practice forms, and automates scheduling of all recurring audit-related activities.
MasterControl 21 CFR Part 1271 validation products and services address different needs based on individual risk assessment. These products and services are designed to allow continuous validation by dramatically reducing the time, pain, and cost involved in software validation.
You must train all personnel, and retrain as necessary, to perform their assigned responsibilities adequately.
MasterControl 21 CFR Part 1271 Training automates assignment and monitoring of training tasks and grading of online exams. Allows sequencing of training courses, so after a prerequisite is completed, the next course is automatically launched. Provides group sign-off feature for verifying training of large groups of employees.
Any change to a process must be verified...to ensure the change does not create an adverse impact elsewhere in the operation, and must be approved before implementation by a responsible person with appropriate knowledge and background.
MasterControl Change Control streamlines the entire change management procedure according to 21 CFR Part 1271 for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Customizable reports provide real-time status of change control tasks and the entire quality system, allowing a more proactive approach to Good Tissue Practice (GTP) compliance.
|(21 CFR Part 1271.320 Subparts D, E )|
(Subpart D):You must establish and maintain procedures for the review, evaluation, and documentation of complaints...The complaint file must contain sufficient information about each complaint for proper review and evaluation of the complaint...for determining whether the complaint is an isolated event or a trend.21 CFR Part 1271.350 (Subpart E): You must investigate any adverse reaction...You must report to FDA an adverse reaction involving a communicable disease...
MasterControl Customer Complaints streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form which is predefined according to the 21 CFR Part 1271 requirements. Allows a timely escalation to an adverse events specialist while ensuring that required data is immediately collected.
MasterControl is compliant, helping you meet 21 CFR Part 11 and other FDA regulations such as 21 CFR Part 1271 year after year, while keeping compliance costs down.