MasterControl, Inc. helps FDA-regulated companies electronically control and streamline all quality-related documentation and FDA compliance audit management processes. Why shouldn't your company benefit from a solution that most auditors are already familiar with?
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MasterControl Audit is the ideal solution for your audit needs. Depending on a company's specifications, MasterControl Audit is fully capable of automating FDA compliance audits. Using the software, you can prepare audit processes for GLP, GCP, PV, Vendor, Supplier, General Quality, ISO, or GMP audits, MasterControl Audit is equipped to handle the needs of both small companies and large enterprises including Tier 1 pharmaceutical or medical device companies that need to conduct effective FDA compliance audits.
Companies doing business in the medical and pharmaceutical industries are distinctly aware of the importance of complying with FDA regulations. In order for these companies to sustain business, they must regularly clear FDA compliance audits. The FDA gives the official word when clearance is authorized for any company to put regulated products on the market. This is the reason top level executives pay great attention in preparation for FDA compliance audits. Clearing FDA compliance audits and inspections require continuous action and preparation on the part of every company subject to FDA regulations. Audit preparation simply doesn't happen overnight or within a few days or weeks. Solid audit preparation means that organizations are ready for FDA compliance audits every day and every hour. To ensure that the company is able to plan and execute an audit program compliant with FDA regulations, MasterControl offers the only solution that provides scalability to be implemented in an organization of any magnitude.
The very first requirement of conducting an FDA audit is that all audit related documentation must be stored under a single platform which should be easily accessible by auditors without any delay. MasterControl Audit provides an online repository for electronically storing information that is readily accessible by authorized users from around the world. This allows vendors, employees, stakeholders, and auditors to collaborate in the audit program and discuss quality issues pertaining to standard operating procedures (SOPs). The solution also provides automated task assignment and automated follow-up so that employees associated with the audit program are continuously on the same page regarding their tasks.
In order to gauge and improve the efficiency of audit procedures, management runs different types of audits (internal, customer, external, etc.). MasterControl Audit has the capacity to plan and execute various audits on varied frequencies. The system can execute multiple audits simultaneously without affecting performance. Moreover, the audits are divided into different stages for more efficient gathering of findings that can, using MasterControl, be effectively tracked through advanced tracking forms. This feature helps auditors manage all QA, QC, and QM activities without any hassle. Once the findings are collected, the advanced CAPA functionality can help overcome any residing issues in the procedures. When CAPAs are well tracked, management can always remain aware of the corrective and preventive actions applied on each issue.
Risk assessment is an important aspect of FDA compliance audit as well, since it helps highlight the major risk factors that affect a company's business. Management can utilize MasterControl to standardize the risk assessments and align them with FDA compliance audits. This feature also helps in standardizing and categorizing not only risks, but all judgments, CAPAs, findings, memos, activity workflows, root causes and document templates for each risk as well. MasterControl Audit also automates reporting, report responses, email messages and notifications, system messages, and the prioritization of audit findings. Eventually, the company will be able to analyze audit data and generate reports for building a sound understanding about the weaknesses and strengths of the business.
To learn more about preparing for FDA compliance audits with MasterControl's automated audit solutions, please feel free to contact a MasterControl representative.