Audit Management and Tracking Software
With growing complexity of businesses and types of audits that need to be conducted, there is a need of efficient audit management software with end-to-end functionalities for managing the complete audit life cycle.
Giving the fact that managing schedules, solutions, internal and external audits can be a herculean task, AmpleLogic Audit Management and Scheduling software makes these processes easier by ensuring proper management via automating and streamlining these processes as opposed to the current paper-based challenges.
Types of Audits include:
- Regulatory Audit
They 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.
Conducting internal audits (or self-inspections) and external audits of suppliers and outsourcing operations are important parts of a good quality system. Audits helps in evaluating compliance with the requirements of the quality system and providing feedback to management for continuous improvement.
Auditing has a significant part in all of the three objectives.
In order to achieve product realization, appropriate quality materials must be purchased from approved suppliers; supplier approvals may sometimes involve supplier audits.
Establishment and maintenance of a state-of-control requires periodic reviews of operations and processes; auditing of such operations and processes may be used to conduct periodic reviews.
Results of periodic audits will serve as the inputs to continuous improvement program.
Main Objectives of Pharmaceutical Audits
- Pharmaceutical manufacturers commonly use an effective mechanism to verify products compliance with GMP (Good Manufacturing Practice) regulations.
- GMP Audits important goals include:
- Verification of control systems and ensure Manufacturing is operating under a state of control
- Discovery and prompt Correction of potential problems to avoid recurrence.
- Establishing a high degree of confidence on products and satisfaction from customers
The importance of conducting both internal and external audits
- Include internal and external audit results as part of the process performance and product quality monitoring system.
- Implement corrective actions and preventive actions (CAPA) based on audit observations and audit Compliance.
- Audit results are included in management review of the quality system
Challenges in Audit Management Software System
Auditing can be very cumbersome especially when dealing with pharma organizations that have several branches all over the world. These organizations tend to have many employees, multiple accounts and record books, statutory records and documents. This makes it quite difficult for auditing to be carried out effectively on all those branches.
Difficulty in Audit Collation
Auditing aids in risk assessment for it is viewed primarily as a safeguard measure and done primarily to provide assurance to organizations.
This risk assessment is conducted within different segment of the organization and this is tedious as each area of operation has its risks and faces its challenges. Hence, it is strenuous establishing a common ground after audit is carried out.
Missing Audit Observations and Findings
Observations made in written format during the course of auditing can be destroyed, stolen or get missing. This is due to the fact that these observations are made mechanically on paper and filed.
Other times, there is need for transfer of data in hard copies through mails when they are required in other sections or branch of the organization.
Spreadsheets are an intricate part of audit management systems as the system does not function without them.
Making spreadsheets manually is excessively time consuming and limits the entire quality management system.
Audit Planning and Scheduling
When planning and scheduling an audit, a lot of complex processes need to be addressed and when doing it manually, it involves processes like planning the audit calendar, writing the appropriate scope item documentation, informing people of their individual tasks, finding and printing checklists, etc. The planning and scheduling phase is already strenuous but when done manually, it worsens.
Audit Planning Calendar
Audits are carried with the help of an audit calendar and this varies year in, year out as auditing agendas are adjusted. It puts in to perspective, available resource and materials in place for the entire auditing. This is done so that due process is followed and an effective audit is carried out.
Features of AmpleLogic Audit Management Software
Simplified Audit Scheduling & Planning:
- Any type of audit can be scheduled with the aid of the Audit Annual Calendar This feature allows information to be captured in detail by providing the ability to review, comment and publish confirmed schedules to departments concerned. This helps to perform regulatory duties and help reduce labor and effort of the team.
- If there is a surprise internal audit on the AmpleLogic Management software and tracking system, the details can be entered accurately after it is done.
- AmpleLogic Audit Management Software provides a separate flow for each individual for all types of audit.
- Details can be captured when internal audits are carried out. This is done to ensure that a very good audit can be used as a reference for auditors on the same level.
- Blank responses can be generated automatically with the aid of an Automated Audit Report Creation. This feature aids the avoidance of undue repetitions on the audits upon completion and ensures easy integration for easy transition between reports.
- An auditor with permission can directly enter findings into the system. In doing this, the auditor avoids the duplication of re-entering findings into the system from hard-copy.
Ease of Communications
- Communications and information are easily circulated with the aid of automated alerts and notifications. This ensures that defined workflow processes are sent across efficiently for required approvals and authentications. It promotes effective customer services with follow-up e-mails sent automatically to the user’s e-mail address and ensures a secure pathway.
Integrated Quality Systems with other Pharma Process Areas:
- AmpleLogic Audit Management Software is designed to be flexible in integrating with other quality systems and establish a seamless and controlled workflow between the audit management system and the 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 system.
Critical Advantages of Audit Solution
Integrates with other quality systems
- Effective audit management software maintenance by quality managers due to the seamless integrations and communications between systems.
- Analysis of non-conformance and track findings at the touch of a button for further preventive and corrective actions to be easily carried out by CAPA and other follow-up procedures
Automated Audit Reports
- Subsequent audit reports and review trends are easily generated with the automated system and the generated information is secure with little or no wasted time or efforts.
- AmpleLogic Audit Management Software provides a central point which integrates the entire audit life cycle.
- This allows for planning, scheduling, preparation, reporting and tracking of audit actions through to the end. All this is done from one electronic system.
Audit Template Generation
- Automatic generation of Audit templates from the system which are compliant with the standards of FDA, 21 CFR Part 11, EU Annex 11 and other regulatory bodies.
- It enhances visibility across all the systems and hence, facilitates smarter and faster decision making. This in turn, reduces the number of raised CAPA’s or Change Controls or Deviations.
- This automated and web-based system, makes work easier, more reliable and efficient by carefully avoiding undue repetitions and errors during an auditing process.
- Audit evidence are being captured in real time and can be easily interpreted. This is because it makes use of videos, photos and sound recordings to ensure that it is well understood and visually appealing