Out of Specification Software
Auditing is a critical function within a pharmaceutical company. The aim of carrying out a GMP audit in the life sciences Industry is to verify compliance with the principles of Good Manufacturing Practices and to propose any necessary corrective actions. The gaps identified in the audit check list help the management to review the quality system of Pharmaceutical and Biotech Companies.
Objectives of Audits in GMP Environment
Conducting an audit has been identified as an effective means of evaluating GMP compliance with these three objectives of the quality system.
- Verification of the control systems adopted by the organization and ensuring that the GMP regulations are being followed through these controls.
- Identifying potential problems and corrective actions to resolve them along with solutions to avoid recurrence.
- Establishing a high degree of confidence on Drug products and Drug Substances, and satisfaction from customer
Types of GMP Audits and the goals
There will be 4 types of Audits in the Regulated Industry like Pharmaceutical and Biotech.
Internal Audit, Customer Audit, Vendor Audit and Regulatory audits conducted by US FDA, MHRA, WHO
- In order to achieve Drug product realization, appropriate raw materials must be purchased from approved suppliers which involves vendor audits.
- Establish and maintain a state of control which necessitates periodic reviews of operations and processes. Internal audits may serve as a means of conducting such periodic reviews. Results from these internal audits serve as an important input for continuous improvement.
GMP Audits in Life Sciences Industry are conducted in Three Stages:
- Stage 1 – Planning the audit and initiating it
- Stage 2 – Carrying out the audit in the facility
- Stage 3 – Filing the audit report, identifying corrective and Preventive Actions, Follow-up, Effectiveness Checks, and closure
Challenges in Manual GMP Audit Scheduling and Tracking findings
Audit Planning and Scheduling
Organizations operating in different geographies with multiple facilities and branches find audit planning and scheduling cumbersome. Creating an Annual Audit Calendar and communicating the audit schedule to concerned departments with due reminders is a strenuous job when carried out manually.
Audit Execution Activities
Organizations undergo multiple audits from different regulatory bodies and customers throughout the year, which may result in delays in responding to the findings.
Auditing involves various important data such as audit observations (findings), auditee response, and audit reports. Paper based record management is always prone to data security issues. Ensuring security and confidentially of these data is a rigorous task.
Archiving past audit records supports the organization in maintaining reference documents that provide clear knowledge of the errors occurred in previous audits. Properly archiving such historical data is essential to make them easily accessible when they are needed.
GMP Audit Scheduling Software
AmpleLogic Audit Management Software enables organizations to execute audits effectively by automating and streamlining the Audit Management process, and addressing the current paper-based challenges in managing audits.
The solution, by eliminating the inadequacy of a paper-based system, strengthens product quality monitoring and enhances process improvements.
Amplelogic Audit management Software is developed on our LOW CODE Platform.
Features of GMP Audit Management Solution
Hassle-free Audit Planning and Scheduling
- Easy audit scheduling with Audit planner and audit calendar. Audit Agenda can also be defined while scheduling the audit.
- Auditee can be communicated on the audit schedule and audit agenda via email notification triggered by the software program. Auditee, in case of an Internal Audit, will have the provision to change the schedule by citing an appropriate reason.
- AmpleLogic Audit Management solution has the feature of capturing critical information of Internal Auditor such as Auditor’s total year of experience, qualification, and areas of expertise. This feature reinforces the fact that audits can greatly benefit an organization when it is carried out by an experienced auditor with the market acumen necessary for performing thorough audits.
- A certificate for internal auditor can be generated within the solution acknowledging the competence of the auditor which is critical in performing the audit.
- In case of Regulatory Audits too, Auditor information is maintained to prepare for any upcoming Audits from the Same Auditor.
Flawless Audit Execution
- Audit findings and auditee responses are captured by the software, making sure that this invaluable data is secured and rightly accessible to authorized users.
- Audit Checklist is a vital instrument in audit execution. While capturing the audit observations, users can upload the checklist into the Audit Management solution.
- AmpleLogic Audit Management also has qualitative rating system (Minor/Major/Critical) to note the severity of audit observations.
Integration with CAPA module
- Once the audit is executed, the findings are assigned to responsible departments in the pharmaceutical Plant
- The responsible department/s will respond back with the Root cause and propose appropriate corrective and Preventive Action.
- AmpleLogic Low Code Based Audit Management Software is capable of integrating with CAPA management module. The CAPAs can be initiated and closed at the CAPA Management module with enabled status tracking at the Audit Management system.
- Once all the CAPAs are closed, specific findings will also stand closed. When all findings are closed then the Audit report will be closed.
- The solution generates a range of graphical reports e.g., category wise audits, criticality wise audit findings reports, department wise audit findings, findings closure status reports and the like. Such intuitive reports give actionable insights to the management helping them achieve the objectives of the audit in the best possible way.
- Repetitive Findings report will help the management to keep more focus on specific areas
Benefits of an GMP Audit Management Software
Managing Audit End-to-End
- An Electronic Audit Management system takes care of the entire audit life cycle starting from audit planning and Audit initiation through to audit findings, action item implementation and closure.
- A pre-defined workflow makes such a painstaking job smooth with proper approval mechanism and review system in place.
Simplified Audit Scheduling
- A periodic task like auditing necessitates planning and scheduling audits round the year. Manual processes can make such a task very complicated and concerned teams may not receive timely alerts. An Audit management software triggers auto reminder on the schedule and enables the teams to be audit-ready in advance.
- An Automated Audit Management Solution acts as a central location where all audit (Internal/External/Customer and Regulatory) information can be stored securely eliminating the potential threat of missing audit findings, response, or audit reports.
Integration with other Quality Modules
- Seamless integration of Audit Management software with other quality modules especially CAPA Management helps auditing achieve one of its key objectives, that is continuous improvement.
- Various audit reports and trends get easily generated by an automated solution and serve as an important toolkit for effective audit
Our GMP Audit Software will also comply with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA,SFDA,NAFDAC, MEDSAFE,MHLW, MCAZ, SWISSMEDIC,KFDA and MoH
Other industries that can take advantage of GMP Audit Tracker
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages