Whenever the word Audit comes into the picture many thoughts evolve for quality professionals. For all the professionals in an organization, audit management is one of the most critical, central, challenging and time-consuming part to their role, also challenging Regulatory audits can make or break the manufacturing companies as the company’s future lies on the performed audits.
AmpleLogic Audit Management and Scheduling Software enables the organizations to manage audit schedules, internal audits as well as external audits by automating and streamlining the Audit Management process, addressing the current paper-based challenges in managing audits.
Audits can be either:
- Regulatory Audit
Audits are conducted in three stages
- Pre-Audit activities – Audit Planning.
- On Site Activities – Audit Execution.
- Post Audit Activities – Reporting, Corrective Action, Follow up and Audit Closure.
Main Objectives of Pharm Quality Audit:
- Pharmaceutical manufacturers commonly use audits as an effective mechanism to verify compliance with GMP (Good Manufacturing Practice) regulations.
- GMP audits important goals:
- Audits are intended to verify that Manufacturing and Control Systems are operating under a state of control
- Audits help in correction of potential problems on prompt.
- Audits can help to establish a high degree of confidence
Challenges in Audit Management:
- Regulatory Audit Flexibility: Most of the pharma companies have many branches all over the globe with large number of employees, this makes it very difficult to conduct an audit.
- Audit Comparison: Risk assessment is done based on area of operation and it differs from place to place which makes the manual process complicated.
- Audit Evidence for reference: Evidence in the form of written document always have a danger of getting damage or lost.
- Audit Findings as reference: Sometimes the data findings of an audit at one place can be a reference to an audit at other place, in these scenarios company need to send hard copies of the data findings through mail.
- Eliminate Spread Sheets: Traditionally, audit management systems are comprised of a combination of spreadsheets and other manual processes. The manual steps required for these systems add to an already limited audit time period open to quality management professionals.
- Audit Planning: In the planning stage, manual steps means- a number of time-consuming tasks including planning the audit calendar, writing the appropriate scope item documentation, notifying people of their individual actions, finding and printing any Audit Checklists.
- Audit Scheduling: Planning and scheduling audits can also be complex, according to professionals, it is one of the biggest audit management challenge.
- Audit Planning Calendar: Another challenge is that the annual audit calendar can have small variations year on year. Annual audits are scheduled but there may be audits that arise unplanned (Unplanned Audits). Managing the resources to make sure everything gets done can be a major obstacle for quality managers, particularly when it requires input and commitment from other people co-ordinating others’ time management and ensuring they are properly trained to complete an audit.
Features of AmpleLogic Audit Management System
- Simplified Audit Scheduling and Planning:
Any type of audit can be scheduled at Audit Annual Calendar that allows information to be captured in detail, by providing the functionality to review, comment and publish confirmed schedules to involved departments. This helps to perform regulatory audits and annual audit calendar reduces effort of audit team.
- One of the unique feature of AmpleLogic Audit Management is that if there is a Surprise Internal Audit, the details can be entered after the audit is done.
- There is a separate flow for each and individual audit whether it might be internal, vendor or regulatory audit.
- When internal audits are conducted, there is provision to capture the details of the audit findings so that will be a reference for the same level auditors.
- Automated Audit Report Creation:
The system has capabilities to automatically create a blank audit response report immediately after completion of the audit. The report is not only auto generated but the information within the audit schedule is moved into the report reducing repetition. Besides the audit schedule and audit response, reports are linked to each other to have a seamless switch between them.
- Direct Auditor Entry:
An auditor with permission can directly enter the findings into the system and avoid the duplication of re-entering findings into the system from hard-copy.
- Automated Alerts & Notifications:
This practical feature ensures that the users are automatically communicated at defined frequencies and defined workflow steps about the approaching due date for required actions. Users are notified directly through follow-up e-mails that are sent automatically to the user e-mail account. Besides, the system auto escalates the overdue to the concerned authority to bring immediate response.
- Integrated Quality Systems with other Pharma Process Areas:
The Audit Management Software is designed to be flexible (Design Flexibility) in integrating with other quality systems and establish a seamless and controlled workflow between audit management system and rest of the quality systems specially CAPA Management. The CAPAs originating can be initiated and closed at the CAPA Management with enabled status tracking at the Audit Management.
- Connections between multiple systems can help quality managers to maintain an effective audit management system. As audit findings will likely lead to corrective and preventive actions and a number of follow-up tasks, it would be extremely valuable to the quality professional to view and analyse non-conformance’s and findings at the touch of a button. Without an automated system, it can be difficult to generate the subsequent audit report and review trends because this information is almost impenetrable without an excessive amount of time and effort.
- AmpleLogic Audit Management Software provides a central focal point which integrates the entire audit lifecycle, allowing to plan, schedule, prepare, report and track audit actions through to closure – all from one electronic system.
- Automatic generation of Audit templates from the system which are compliant with the standards of FDA, 21 CFR part 11, EU annexure 11 and other regulatory bodies.
- Enhances visibility across all the plants which facilitates smarter and faster decision making and thereby reducing the number of raised CAPA’s or Change Controls or Deviations.
- Simplifies the day-to-day work by standardizing methods and automating the repetitive tasks thereby boosting performance and effectiveness of entire auditing process.
- Audit Evidence Capture: Capture evidence in real time and attach any type of common file, including videos, photos and sound recordings. The advantage to attach evidence is that non-conformances can be viewed the same way by everyone and there’s no need for interpretation. This process also eliminates the need to make lengthy notes to describe an issue.