Quality systems are essential and necessary part of the processes to ensure the product / process quality; It is the foundation for the patients, consumers and regulators to have the confidence in the safety and effectiveness of the products and reliability, sustainability and productivity  aspects of business.  On the other hand, it is continuously tested and challenged for its rigour and robustness by the business and operational environment, which requires it to be agile, reliable and productive. 

Quality begins with the intent, which is fixed by management. ~ Edwards Deming

The regulatory agencies are gradually and naturally progressing and driving the oversight – scrutiny – expectation from procedural compliance – implementation status – effectiveness checks.  Apart from audits, one such step is the implementation of “Quality Metrics” which provides the overall state of Similarly business  / management is focussing on the productivity and cost of quality.

Digitisation of Quality systems and processes offers an apt solution for assuring performance requirements required of the quality system; at the same time, minimizing and eliminating the bottleneck / constraints of the manual processes.  While the quality systems and digitisation alike, are require to strike a right balance for a) compliance with regulations b) implementation environment / complexities  c) flexibility / agility for ease of use, and many more such aspects;   Among many aspects of deployment of any software application,  the “direction and design” considerations shall determine the “true leverage” of the digitisation;  However, it is limited by prioritizing the immediate concerns, short-term targets, rigidity in the adapting the digitized processes, which almost always involves re-engineering the business processes.

“Design creates culture. Culture shapes values. Values determine the future.” – Robert L. Peters

Success of the digitisation depends on the balancing the change management without losing the true potential and impact of the features and functionalities of the digitisation platform;  Maintaining the Compliance, Efficiency  and Productivity in an continually evolving operations & business environment, is an common denominator.

Common objectives and targets

  • Compliance
  • Reporting
  • Accuracy         

Overcoming the challenges

  • Traceability
  • Availability
  • Efficiency
  • Data Accuracy     
  • Data Accessibility
  • Realtime Monitoring
  • Consistency
  • Security

Opportunities & Leverage(s)

  • Revisiting the business processes &
  • Automation
  • Decision making – Intelligence & Analytics         
  • Collaboration 
  • Continuous Improvement 
  • Scalability       

Initial phases of digitisation consists of islands of attempts at leveraging the excel tools for tracking – tracing – reporting attempts, which are essentially duplication of corresponding formats. We don’t design those summary reports into SOPs, as they would be compliance requirements; and hence we maintain the online form, succeeding the SOP logs/formats. Because of the redundancy even if managed well, has to face some challenges with manpower, accuracy of data etc., which leads the path to next level of accuracy. 

Level 1:

Complexity: 3/5

Impact: 1/5

Drivers/opportunities: +Discipline’s

Operational Impact: Compliance-Accessibility-Traceability

Function/Business process Use case: Adoption of right metrics frequency of oversight & controls

Technical Use Case: Manual business process re-engineering to take the compliance to point of source/origin of data.

Level 2:

Complexity: 1/5

Impact: 2/5

Drivers/opportunities: ++ Eliminating the burden of managing the paper control, traceability, availability, contemporaneous documentation

Brief Description: Paper on Glass with Integrated reporting / reviews

Operational Impact: eliminate the log books; current status of events ( equipment, samples, processes etc )

Function/Business process Use case: elog books

Technical Use Case: Active / Passive – rule based – interlinking and interlocking of the activities & processes

“We can’t solve problems by using the same kind of thinking we used when we created them.” – Albert Einstein

While the initiation and evolution of digitisation can be often linked with the initiative of some personnel interested to solve a business problem, which often finds traction for gradual adoption of tools and technology.  2nd most common initiative is to solve local problems within function or unit; This phase is critical to address the diverse priorities,  preferences; which if not handled effectively, shall lead to added complexity either with efficiency of roll out or add to complexity with diverse applications / solutions deployed across sites without forethought on the total leverage of the digitisation process, technology;

Majority of the digitisation’s projects oscillate between the digitisation of workflows or business processes which are again limited or focussed on the specific business processes. ( Quality – LMS , DMS , QMS, etc, Quality Control – LIMS, CDS, SDMS, etc,; Manufacturing – WMS, SCADA, MES, eBMR etc )  and limited or specific scope of integration, often within the areas., viz., LIMS-Instrument interface, MES-SCADA /WMS.

Level 3:

Complexity: 3/5

Impact: 2/5

Drivers/opportunities: +++ enhanced productivity of integrating preceding / succeeding  or inter-dependent processes

Brief Description: Business Process workflow within process or section

Operational Impact: standardize the processes, and build the reliability and robustness of the compliance processes through replace the paper trails with electronic trails + smart reports

Function/Business process Use case: sample management tracker (receipt – sampling – assignment / analysis – results)

Technical Use Case: analysis sequence flow – consistency

Level 4:

Complexity: 4/5

Impact: 3/5

Drivers/opportunities: ++++ eliminate / minimize the post-activity review criteria through rule-based consistency / compliance reviews.

Brief Description: Integration ( processes and equipment’s )

Operational Impact: standardize the processes ( performance of instruments – methods – personnel ) with interlock and interlinking of different systems

Function/Business process Use case: binding of the Inter-dependent systems viz.,  availability / validity of qualification  status of equipment / analyst ), CoA/AR locking against  auto-triggered OOS / OOTs, ,  receiving and posting back the samples/quantities from ERP / MES

Technical Use Case: Equipment/instrument connectivity for auto transfer of data/results/ reports

“The only limit to our realization of tomorrow will be our doubts of today.” Franklin D. Roosevelt

Quality systems is not about the definition of procedures and compliance status; it is how it works to ensure and assure the intended results/affect ; and extension of it to the digitisation of the quality systems, i.e., it is not about adopting a tool,( read it as, force fitting equivalent to the digital paper on glass; or vice versa of adopting the out of the box features and functionalities) but it is about bringing about the transformation to leverage the digitisation which suits the organisational environment and challenges and delivers the improvements with cost, time, and without adding further complexities or newer challenges.

The true and complete leverage of the digitisation can only be brought around through holistic objectives and employing an phase wise approach with expanding scope of implementation. Which involves either an pro-active or concurrent integration preceding or succeeding processes viz., ERP/WMS-LIMS; LIMS-WMS, WMS-MES.

Level 5:

Complexity: 5/5

Impact: 5/5

Drivers/opportunities: +++++ integration of primary data ( either instrumentation or business processes ) to eliminate the redundancies , inconsistencies and dependencies

Brief Description: Automation

Operational Impact: Robustness of products, TAT / SLAs, Optimisation of man-powers

Function/Business process Use case: Business process re-engineering ( compliance systems and processes )

Technical Use Case: Sample preparation automations