Source: https://www.mastercontrol.com/uk/21_cfr_regulations/1271.html?lne=nmm&nlc=part1270_1271mm
Timestamp: 2017-10-23 13:38:31
Document Index: 112515200

Matched Legal Cases: ['arts 1270', 'art 1270', 'art 1271', 'art 1271', 'art 1271', 'art 1271', 'art 1271', 'art 1271', 'art 1271', 'art 1271', 'art 1270', 'art 1271', 'art 1271', 'art 1271', 'art 1271', 'art 1271', 'art 1271', 'art 1271', 'art 1271', 'art 1271']

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 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.
(21 CFR Part 1270.31 Subpart C)
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.
(21 CFR Part 1271.160 Subparts D)
(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.
(21 CFR Part 1271.170 Subpart D)
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.
(21 CFR Part 1271.225 Subpart D )