How does the use of an e-QMS enable better management of quality events? How does it protect against the consequences of paper or manual management? There are many advantages, from the interaction between events, monitoring of actions, reminders to persons involved, management of deadlines to follow-up supervision mechanisms after closure.

1. Innovative solutions, which have become an important component in company information systems

Management of e-QMS (Electronic Quality Management System), has become an important transversal element among pharmaceutical organizations and medical device manufacturers. This is a tool that serves all employees who are directly or indirectly associated with product quality and patient safety for quality management.

These systems generally allow management of:

• Quality system documents, whether these are the classic documents of a quality document system (SOP, instructions, forms, etc.), controlled documents (such as specifications, for example), simple stored documents (texts, quality agreements, etc.), or even records.
• Employee training programs, from authorization at the workstation to the monitoring of recurrent training courses, training examinations, etc. some of which are true e-learning platforms.
• Quality events, which include deviations, customer complaints, non-conformities, OOS/OOT, CAPAs, and change management.
• Audits, whether these are internal audits or external supplier audits.
• The quality part of supplier management, authorization, request for corrective action plan, clocking-in card, etc.

But also more rarely, management of risks with both the risk analysis development part and the associated mitigation plans, projects, etc.

Although this list looks a bit like a catalog, this does not prevent us from seeing that the coverage is fairly broad and touches on different subjects of quality management systems. Very clearly, whether an electronic or manual method is used, this area needs to be covered, but the introduction of a computerized tool meets all these needs simultaneously.

But then, may we ask how computerized coverage of needs is better and does it allow needs to be met more easily than a manual paper method?

2. Technical tools that guarantee good practices

Needless to say, the tool provides data control functions and rationalizes the entry of information into an electronic form. It allows the inclusion of numerous checks, a list of values, which guarantee the consistency of data, even between data. This is a condition for subsequent use for analytical and statistical purposes. In fact, if your data is not consistent and is not based on stable permanent frames of reference, you will not be able to use it later on.

We can see in different FD 483 issued by the FDA that some companies do not show proof of permanence in their information management within their quality events management, and that this is considered a potential breach of cGMP requirements.

In the technical tools, we find a whole set of classic functions, such as an electronic signature and user identity management which guarantees the uniqueness of profiles and therefore access to persons authorized for certain roles. Again, the FDA noted failures in this respect (lack of unique usernames and passwords, etc.). Classic functions such as the audit trail, management of metadata associated with the items, access protection etc., are now part of the standard toolbox of solutions present on the market.

Technical tools therefore allow rigor in data entry, provide consistency of the information entered and all of the advantages that technology can provide, such as more advanced ergonomics, comfort and readability of processes, assistance with the use of tools. They are also the guarantor of the continuity of data entry and of a certain consistency of frames of reference usable for analysis purposes.

3. Better time management

Technical tools also allow an improved flow of data between the different players. One of the recurrent problems in the management of quality events and CAPAs is the length of time taken to manage these events when done manually. This time management may also be constrained by the regulations. In some cases,  (for example complaints), time frames are defined precisely. Generally, the time devoted to the handling of quality events should not be excessive. Whether investigation or resolution is involved, quality events must be handled quickly. It is always difficult to justify time frames of several months, even several years in the resolution of quality events and CAPAs, except when this is guided by a specific action plan.

A process is a succession of tasks divided between different people in an organization. When this process is supported by a physical resource such as paper, the time devoted to transfers between the different tasks is sometimes too long. Process optimization is performed in two areas: the reduction of dead time between tasks, and management of the optimization of the task itself. When we are confronted by a manual process, optimization of inter-task time is the first improvement to be made. It is the very essence of a computerized system to optimize routing between the different players in a process. Transfer time is almost eliminated at this moment. The tasks themselves can be optimized, as even with automation, the user who has to intervene in a task must be informed, even reminded if necessary. It is henceforth possible to define time frames for tasks that will be managed automatically and may be the subject of reminders or particular messages. It is even possible to call on still more sophisticated automation, like sending a task to a group of authorized persons and to consider that first person in the group to take charge of it will do it for everyone, or to set up escalation processes with referral to another person when a certain time is exceeded.

As we see, this time optimization should solve the problem of process duration, as much as possible, within the limits of the actual tasks to be accomplished. This is indeed a question of the necessary duration and not the duration to be expected from episodic processing actions.

4. A methodological support

There is an area in which these tools are yet more powerful, however, that of methodological support.

These tools in general support the best practices observed in relation to the handling of quality events. In FDA Warning Letters, significant shortcomings are often observed in the methodological handling of events and CAPAs.

For example, a CAPA which has not been the subject of a root cause evaluation, or an effectiveness measurement which was not performed and /or documented. The processes present in e-QMS tools are generally built on the best practices which take into account the requirements of texts and the expectations of inspectors.

Using such a tool is therefore a guarantee that the required approach is being followed and that things are being done “in order”.

In the context of a manual approach, it is relatively easy to infringe the method – intentionally or also non-intentionally  – which is not possible with an automatic process that will impose the steps and only allow the process to move forward once the previous steps have been duly completed. This methodological input may even make it possible to go relatively far.

For example, in the context of a CAPA, a check of the effectiveness of the actions implemented is required. Very often, this check is carried out by verifying that the actions are implemented correctly. Nevertheless, it is often difficult to evaluate the corrections carried out other than over the long term.

Some systems for example allow the implementation of automation that will enable the collection of events, which will read the “weak signals” arising in the organization with the aim of pointing out a potential displacement of the problem, without  truly resolving the cause. This background monitoring (this “watchdog”) makes it possible to respond to a real concern of the texts that demand measurement of the effectiveness of the CAPA with regard to removal of root causes.

Methodological support ensures the sustainability of CAPA or quality event processes and concordance with quality procedures explaining the approach. This deviation between practices on the ground – especially when they are in a manual environment – and the approach fixed in the procedures is, here again, a cause frequently cited in the Warning Letters (was not conducted or documented in accordance with procedure, etc.).

The guidance, methodological supervision, method sustainability and document consistency function is a valuable asset provided by the e-QMS and makes it possible to rely on a state of the art technique that complies with the texts and is shared by many companies.

5. Transversal quality

The different processes of an organization interfere and interconnect.

Even more in the field of quality. It is not at all improbable to imagine a chain of events where a customer complaint, for example, may lead to the opening of a deviation highlighting severity or recurrence levels that impose the need for a CAPA. This same CAPA in its turn could initiate requests for changes in documents,  changes to tools or organization processes and, these changes will of course have to be communicated to staff, be the subject of training, and of a check that employees have successfully acquired the skill. Managing such a sequence of events manually can sometimes prove a real nightmare.

In the course of their development, ,organizations have often equipped themselves with different solutions that are not necessarily related to each other. Many companies use one software application to manage complaints, another for change control management, an Excel file for CAPAs and deviations.

Quality is transversal within the organization and it is  natural that an action or series of actions call for a cascade of other actions. But management using successive Excel tools along with a variety of different software is sometimes a feat.

Still more annoying, the chances of making an error then accumulate, in repeating and recopying the information from one process to another, thereby increasing the possibility of making a mistake.

Another example: imagine that when analyzing a deviation, it so happens that you have to complete a 5 W (Why, Who, Where, When, What). If this deviation highlights a necessity to process a CAPA, this information entered in the 5 W will not be automatically recovered, but will have to be re-entered as these are then the first input items in the investigation.

Loss of time, loss of data, risk of errors, everything comes together to generate new deviations! When they incorporate all these processes, the IT tools are capable of promoting soft transversal skills, without recopying information, with natural links in the subjects, without loss or degradation of data.

6. Data security, and greater reliability

It escapes no-one that data security is an important point and that data relating to quality and the handling of quality events is important data whose permanence and security must be guaranteed.

Computerized systems allow control of access, management of the authorizations of persons, thereby guaranteeing that only authorized persons can access some functions. But additionally, they allow us to guarantee data reliability and permanence.

Who has not never had to cope with the loss of a document? Either because it has slipped inside another document, or is buried in the pile of work on a desk?

With an e-QMS system worthy of the name, nothing is lost, nothing is deleted, everything is tracked. Impossible to misplace a CAPA or a deviation. In addition, the system must be validated and its validated status maintained.

IT tools, when they are used appropriately with appropriate data validation and protection methods, therefore provide a level of data security that is much more in phase with the requirements of Data Integrity than manual management in paper mode.

7. The treasure trove of data

But above all, and this is perhaps the point that is most disturbing with the manual method, it is then  almost impossible to perform an analysis of your data.

The FDA encourages the performance of a retrospective analysis of its Quality events (retrospective review of CAPA, etc.). It is therefore necessary to have computer access to your data.

Companies rest on a veritable treasure trove that is often not exploited: their data. Unfortunately, it is often very difficult, even impossible, to analyze it if it is not all consistent, established using the same frames of reference, and technically accessible.

A customer complaint may concern a product, as well as a deviation, a CAPA, or a change control. If your system is heterogeneous, or managed manually, you will not be able to perform extractions or analyses on the basis of an item code. The value of being able to query quality events relative to a batch number, a production equipment item, or a product range, may also be easily imagined.

When a system manipulates data manually or with heterogeneous tools, the reference system data (item codes, batch numbers, equipment numbers, suppliers, etc.), is rarely shared rigorously. Still less when data in paper format is involved. If we want to perform a data analysis, the data must then be reprocessed at great cost, and re-entered with the risk of errors. This then never happens.

Such a situation implies an attitude relative to quality that is mainly reactive and defensive. The possibility of performing a trends analysis and of deducing deviations predictively, is almost impossible.

Conclusion

It is clear that IT tools for the management of Quality systems, events and CAPAs provide real advantages over manual management. Whether it is a tool that obliges compliance with rigorous data entry, a methodological tool that will support you in performing a complicated investigation, or the acceleration of event processing, there are significant benefits.

The greatest advantage is then the possibility of working on deposited information that is consistent, in which it is possible to have a  high level of confidence, with the aim of being able to progress towards what is called  “Predictive Quality”, quality that benefits the patient as well as the company, positive quality.

Again certain rules must be respected, there must be compliance with regulatory requirements (validation, compliance with the texts), but above all full consistency and homogeneity which will then allow you not only to manage your quality events, but to use them to improve your service to patients.