Unplanned-Audits-&-Auditees

Unplanned Audits & Auditees

An unplanned regulatory audit conducted at pharma & life science business sites is enormous challenge and with incomplete quality processes, logs or records can provide inconsistent, unreliable results and non-readiness of documents from the data available in presence of auditors is dreadful pressure on auditee/s and it may lead to quality observations. This may happen when you believe the completeness of the existing documents with respect to compliance when, in fact, they are not.

Finding any small observation, which is in regulatory violation during a pre-audit can lead to an audit finding and if not rectified, tend to fail an official regulatory inspection.

Manual or non-digitized processes, particularly quality processes, might miss some important additional sections, especially when in using spreadsheets, the complexity of ever increasing data can lead to confusion and inability to find the right data at the right time.

Quality Processes and documents

Entire organization’s quality processes life cycle traceability ensures defined procedures for development, manufacturing and testing cycles. Organizational staff must be ready with all quality processes documentation for an official regulatory inspection and provide the documentation and document copies as requested for review, as necessary.

Today trend has changed and given way to implementing more efficient processes with “electronic records and electronic signatures” that meet regulatory requirements instead of paper document records. All data, both paper and electronic, are required under good manufacturing practices (GMP) are subject to compliance regulatory inspection.

Data integrity and GMP

An important subset of GMP documentation requirements in recent years is data integrity.  The macro level definition would be as completeness, consistency and accuracy of data. Complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.

Specific best electronic execution practices to prevent data manipulation for GMP compliance include:

  • Controlled access: for instance, by limiting computer permissions to edit or overwrite data to alter specifications, process parameters or manufacturing methods by technical means
  • Not use shared login credentials (ES): for each user to have unique credentials to identify an individual rather than a group of users
  • Audit trails & reports (ER): to track data creation, alteration. Audit trails should be secure, readable, chronological, non-editable & computer-generated and time-stamped with user information
  • Software administrator: It is an individual independent role from those responsible for administration of infrastructure and solution applications
  • Establish a hierarchical workflow system: to define a role and scope-based system and restrict access to modify data in the workflow

Conclusion

Any regulatory audit is one of the most important events for a pharma or life science organization for inspection readiness and further to make enterprise-wide effective business decisions

But readiness with QMS data is not an easy task. Creating, implementing and maintaining detailed data can take a lot of time and practice to follow enterprise-wide quality processes. And the consequences for missing any requirement on data and records can be major problem. You will fail your next regulatory inspection and face unnecessary regulatory consequences.

Get ready with our core Quality compliance solution, which will help you automate and digitize all your quality processes with seamless integration with any third-party solutions. On the other side, we can help you develop an effective GMP eQMS system for any audit, unplanned or planned without stretching routine workload.

Once you’ve established our eQMS system, be sure to provide the robust data to the auditors, with improved systems, enhanced data accuracy, reduced manual efforts all in all superior regulatory compliant environment.