Corrective Action and Preventive Action (CAPA) - the overall effort to investigate and correct quality issues to prevent recurrence - is an important principle under the Current Good Manufacturing Practice (CGMP) regulations found in 21 CFR Part 606, which covers blood establishments. Such organizations can improve compliance and efficiency by implementing tissue and blood bank CAPA software systems.
Although 21 CFR Part 606 does not use the term CAPA directly, it states that all biological product deviations should be investigated in accordance with the applicable provisions of 21 CFR Parts 211 and 820, both of which require CAPA procedures.
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Tissue and blood bank organizations have realized the importance of complying with FDA, CGMP, and ISO regulations. Compliance prevents revocation of a firm's license to collect, process, store, and distribute blood and tissue products. The survival of these companies is heavily dependent on structuring their processes in accordance to the standards laid out by regulatory authorities. By preventing issues from recurring they are able to avoid facing severe consequences. Although manual and hybrid tissue and blood bank CAPA systems provide the ability to identify issues, these systems lack the necessary infrastructure and setup for effectively and efficiently managing CAPA issues. Because of the inconsistencies and errors inherent to manual systems, many tissue and blood bank organizations are now incorporating tissue and blood bank CAPA software that helps management build a sound CAPA program for dealing with issues impacting the company's business. The MasterControl tissue and blood bank CAPA software system is specifically designed to allow tissue and blood bank organizations to minimize errors and manage CAPA issues quickly and effectively.
Paper-based and hybrid CAPA systems may be inexpensive but management faces inefficiency and wasted resources when extensive man-hours are wasted on managing and approving CAPA documents. Since a manual approval cycle of any document takes longer, it is most likely that a standard operating procedure will go through multiple rounds of updates, which inevitably means that employees will consult an outdated SOP document for executing a process. This is a severe nonconformity in the business which can be resolved through the MasterControl's tissue and blood bank CAPA system that provides a mechanism for automatically documenting procedures and obtaining approval and signatures without unnecessary delays. MasterControl tissue and blood bank CAPA software is entirely web-based which allows employees, vendors, partners, and different stakeholders to collaborate on CAPA documents that are then made available to all authorized users throughout the enterprise. The entire documentation cycle of routing, delivery, escalation, and approval of CAPA documents is automated which also makes it easier to search for and retrieve documents during inspections and audits.
As per CFR 606/current Good Manufacturing Practices (cGMP), the main objective of a CAPA program is to incorporate an effective documentation cycle that quickly approves CAPA documentation for reference by users that are dealing with issues which surface during audits. With MasterControl tissue and blood bank CAPA software, management is able to infuse efficiency and a systemized process flow for identifying and resolving issues that arise during audits.
Paper-based or hybrid CAPA software systems don't provide adequate connectivity between processes. As per 21 CFR Part 11, the requirement is to have a compliant CAPA software solution that effectively tracks corrective actions/preventive actions and customer complaints from incident recording through final sign-off. A CAPA is triggered through different sources, including Form 483 findings, quality audits, customer complaints, etc. It is imperative to connect these sources so that the data collection process is efficient and complete to ensure that critical information does not fall through the cracks. The reliable MasterControl tissue and blood bank CAPA software integrates the CAPA process with the entire quality system. The CAPA program can be seamlessly integrated with other processes critical to GMP compliance such as change control, audit, and customer complaints.
All data collection processes pertinent to the CAPA program function together in unison, serving as the basis for identifying and researching issues and implementing the proper solutions in the system.
MasterControl tissue and blood bank CAPA software captures data through advanced CAPA forms. The solution's 8D process guides quality teams through every step of a tissue and blood bank CAPA system implementation, from identification of the problem to investigation of root cause through correction of the problem and prevention of recurrence. A CAPA form can be launched directly from another form to streamline the overall CAPA process and avoid mistakes during re-entry of data. Links are maintained so users can review a completed process and easily see what triggered the CAPA. The advanced analytics in the software also allow the management to get a clear picture of the actual state of the quality system and the business in general.
21 CFR Part 11 requires tissue and blood bank organization to generate biological product deviation reports (BPDRs) to the FDA in a timely manner. MasterControl's tissue and blood bank CAPA software system allows BPDRs and other reports to be generated on a regular basis. Through the reports, managers have the assurance of compliance and they get a real-time view of the CAPA process and can therefore be more proactive about improving the quality system. With MasterControl's tissue and blood bank CAPA software system companies can maintain strict adherence--with full management visibility--to FDA and AABB (American Association of Blood Banks) requirements.
Therefore, the MasterControl tissue and blood bank CAPA system provides top-down and cost-effective enforcement of SOP best practices that is compliant to the FDA, CGMP, and FDA regulations.
For more information about MasterControl's tissue and blood bank CAPA software, please feel free to contact a MasterControl representative.