Audit verification activity

The standard requires that trained personnel be assigned for management, performance of work, and verification activities including internal quality audits. 

Design, development, and system build is normally a period of intense activity, in which a supplier will be involved in life-cycle activities and will need to provide a set of auditable design and development documentation to support the validation program. For this, the entire design and development process should be carried out to written and approved procedures, and all design, development, testing, and verification activities should be documented and approved in order to provide a level of computer system documentation that can be used to support the pharmaceutical manufacturer s life-cycle qualification activities. 

Despite the similarities that sustainability audits have to compliance and EHS management systems verification processes, there are some important yet subtle distinctions to note. Those distinctions include the scope or boundaries of the assurance/verification activities, standards of practice, assurance criteria and evidence, and content of the assurance report. 

Verification activities carried out according to the verification and validation plan. Typical verification activities include e.g. design reviews, audits of procedure implementation and integration testing ... 

The GMP details certain requirements for the quahty system, such as the independence and responsibihties of the quahty control unit. It requires such activities as internal audit to monitor GMP conformance, employee training, complaint investigation, failure analysis, and verification of proper manufacture and test by QC prior to release of the batch. 

The management staff responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of actions taken and the reporting of verification results (see 8.5.2). 

All relevant departments are provided with adequate resources and trained personnel for the activities related to product realization including inspection, test, monitoring of the design, production, installation, and servicing of the process and/or product. Verification and audit activities are carried out by personnel independent of those having direct responsibility for the work being performed. 

The vendor qualification policy will ensure that vendor qualification activities are performed under the auspices of quality assurance. Additionally, a thorough review of the vendor qualification ownership will be performed, and additional resources will be assigned, if needed. An expanded training program will be developed and implemented to ensure that all staff associated with the vendor qualification program are trained on the new and improved policy and procedures. Verification and monitoring of conformance with the company s vendor qualification policy and procedures will be performed periodically through internal company audits. 

The check stage also involves assessment of the effectiveness of the efforts. This assessment can take many forms, from internal auditing to independent verification. These checking activities are important to sustainability programs in providing confirmation and improved credibility to efforts in social activities that often are difficult to quantify. 

Recording audit observations is an essential part of the audit to enable the auditor to prepare detailed, accurate and complete audit reports which are based on factual observations. Checklists, audit questionnaires and sampling plans are useful tools and should be prepared prior to the audit. Generic checklists may be a good start and can be refined as required for each audit to account for trial-specific issues. Source data verification (SDV) templates are always trial-specific as each clinical trial is unique. Although checklists and questionnaires are very useful to record audit observations, they should never restrict the extent and scope of audit activities and allow for flexibility during the audit. 

Audit notes are indispensable to allow QA auditors to write an accurate report after the audit. Detailed notes allow the auditor to prepare a meaningful audit report which is based on verified observations. All information collected during an audit is considered audit evidence. Information sources in an audit are, for example, document review, interviews and observation of activities. If applicable, sampling techniques may be applied, for example for SDV and verification of information in tables and listings. Audit observations are only considered audit findings if it is determined after comparison with audit criteria that these are not or insufficiently fulfilled. And finally, audit conclusions can be drawn to assess whether the audit findings impact the validity of the clinical data and the safety of the trial subjects. 

Verification of informed consent forms for all trial participants is a key task during audits. The auditor should check if an informed consent form is present for all trial subjects and has been signed by the subject and the investigator prior to any trial-related activity. 

As a final point to this section on inspections, it should be kept in mind that - as it is the case for any other operative procedures covered by the GLP Principles - the Quality Assurance Programme of inspections (and audits) should be subject to management verification. Management has to assure that the Quality Assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice which means that the Quality Assurance has to provide management with periodic reports on its activities, not only for single studies as already detailed above, but for the totality of its... 

To comply with the new legislation the sponsor needs to develop a set of standard operation procedures (SOPs) to cover all areas of trial activities. A quality system should be in place to ensure record-keeping and verification of data entry or extraction of data from the case report form (CRF), capture adverse events (AEs), serious adverse events (SAEs) and unexpected serious adverse reactions (SUSARs) and report in an expedited manner data transfer from source data to database and archiving of the source data for audit purpose. GCP and trial specific training should be carried out and recorded in a timely manner. 

One lesson learned has been that developing a robust compliance verification program is difficult. Along the way they learned that (1) clear ground rules for audits must be established, communicated, and adhered to (2) it is not possible to audit in requirements and (3) the compliance verification organization must be equal with the program managers and the technical authority. In addition, they determined that not just anyone can do SUBSAFE work. The number of activities authorized to perform SUBSAFE activities is strictly controlled. 

Safety Lifecycle activities including audits, assessments, and verifications. 

IV.71. The documented audit results should be brought to the attention of the management personnel responsible for the activity audited. The responsible management should take timely improvement or corrective action in response to the audit findings. Verification of the effective implemented corrective action should be estabhshed and recorded. 

The owner/operator should define when verification, assessments, auditing and validation activities take place to ensure that adequate time and resources have been assigned to these activities. The highest quality projects are obtained when procedures or guidelines are in place to ensure that all activities occur in the proper order with the necessary content. For example, many projects have experienced delays when SIL verification was performed late in the project, and the SIS design was found to be inadequate. 

It should be determined which records of the verification and vahdation results should be maintained for the lifetime of the system. The records should provide evidence that all planned activities have been performed, results recorded, and anomalies investigated and resolved. The records should be made available to third parties for audit and review. The records should clearly demonstrate the traceability of all verification and validation work to the relevant source documentatiom... 

MQA A planned system of activities that provides assurance that the manufactured material meets the requirements specified. This includes inspection, verification, audits, and evaluations of raw materials and finished products to access their quality. 

Establish an effective safety management system/process. Nominate key roles/ responsibilities. Define approval signatories - especially for safety reports. Establish independent verification/audit to reduce chance of undetected error. Establish a workforce-wide commitment to product integrity. Learn from previous mistakes. Initiate a documentary audit trail (identify, log and track all hazards). Airworthiness and safety must be foremost in the minds of the entire organisation. Furthermore, as many legal cases turn on documentation, it is essential that risk assessment activities and choices are documented and that records are kept. ... 

These control systems shall provide for safety reviews, installation approval, independent verification of correct installation and removal, documentation of the modification, marking of installed modifications, and periodic audits of outstanding modifications. These controls shall also provide for communicating the installation of temporary modifications to the design authority to allow for technical oversight and an evaluation of the impact on current design activities. 

These mechanisms help ensure that actions are taken continuously to improve the System. They use findings from self-assessments (gap analysis), and from verification and measurement activities (internal audits, inspections, reviews, observations, etc.)... 

---