Vision of a Match less Quality Management System – Life Science industry

Various 21 CFR part 11 complied systems such as Trackwise, QMS, EDMS, Artwork management system, SAP, LMS system and eCTD are currently prevalent in industry. Each system exhibit highest state of compliance with CFR requirements and ensure cGMP compliance in various operations. Our Quality management systems (QMS) are efficient in following

1.      Tracking open quality systems

2.      Reminding us on pending , due over due tasks

3.      Updating specific required section to remain in compliance with CFR

4.      Ensuring CAPA is triggered for major non compliance

5.      Recording Audit observation and compliance

6.      Running reports and showing what we asked based on batch number and other inf

7.      Follow step by step operational steps and make us audit ready

8.      Close quality systems, remind us for retrospective review

9.      Bring similar incidence and associated CAPA during search , leveling and CAPA

10.  Means capable of doing as we say or help us in complying with CFR , FDA requirements

Even after having above mention features, our QMS system is dependent upon manual intervention of Quality system owners or executors. For example let’s say during any investigation we end up deciding retraining of employees before execution of next batch processing. This action item cannot be closed if training task owner attach training completion documents to QMS task. Further at several incidences it is observed that training the evidence attached to QMS didn’t covered entire work function. Manual intervention such as these exposed us to higher risk of non compliance and put burden on quality team to remain extra vigilant.

In my view a Quality management system should be smart enough to interact with other ERP platform within the company. Further Quality management software should be capable enough to trigger task initiation in other ERP systems and take updates from input coming from other ERP systems. I was thinking of below mention example while visioning this quality management software

Example 1 : Consider an investigation where we end up deciding retraining of batch process records after its revision with respective changes mention in this deviation. This CAPA should trigger a auto revision in EDMS system for master batch record under investigation and shoot notification to document owner about due revision and dates. Further QMS system should review completion of training for each job role it was assigned with in organization.

Example 2 : Consider a deviation associated with stability sample failure of Drug substance and Drug product. In this case our QMS system should trigger auto block of all batches manufactured using these DP and DS. QMS should have override access to BOM in SAP and prohibit further utilization of batches under question to ensure better control on process.

Example 3 : QC out of specification result in personnel monitoring of employee for more than acceptable incidence should trigger restriction of employee access through facility management software. Similar over due training for new procedure , revised procedure, training as a result of CAPA should prohibit use of equipment , instrument, e-BPR systems for concerned employees.

Considering the competitive market landscape, every day changing regulations and companies merger / acquisitions it very difficult to think about cross functional work. But if we think from compliance perspective, more lean perspective and in view of avoiding manual human error we should think about a matchless QMS system. This QMS system can help us in one of the following way:

1.      Avoid surprise non compliance – Manual QA final reviewers have varying skills, knowledge and review efficiency thus imposes risk of uncertainty in performance.

2.      Company changing product names, material names, adding new products, new suppliers and new documents cross functional working will ensure compliance over sight.

3.      No last minute delay: Artwork is approved but not updated in system, SAP recipes approved and not reflecting in system, QMS trackwise query not showing impacted batch, Specification revised but changes not reflected in LIMS software.

Conclusion : The dream of match less QMS system can help ensure CAPA effectiveness programs and avoid future FDA observations. For example major life science companies are adopting Global work culture environment, and therefore if we unable to ensure implementation of CAPA across all sites we are risking our self with future observation and disposition of non complied products.  Also manual interventions impose high risk in QMS standards and practices as they can vary from person to person. We are in the technology revolution visions and imaginations are aligning each other it’s time to think about implementing lean, high compliance index and machine learning in our QMS systems.