change control

The challenges of Change Control: sharing, documentation, training and digitisation

10/04/2021 |
BLOG

The challenges of Change Control: sharing, documentation, training and digitisation

The challenges of Change Control: sharing, documentation, training and digitisation

Change Control is a key system for ensuring the quality of products and processes, especially in the Life Sciences sector where there are significant regulatory complexities.

As defined in the EU GMP Guidelines, Change Control is a formal system whereby qualified representatives from appropriate disciplines review proposed or actual changes that could affect validation. Its aim is to determine whether action is needed to ensure that the overall system is maintained in its validated state.

Change requirements (Change Requests or COC) are not specific to one department, but can affect the whole company. Indeed, they are requested by those who need to implement a change that may impact validation.

When introducing a new line, for example, the Change Request is issued by the engineering and qualifications department and includes tasks for other departments, such as validation. For a change of material or supplier, on the other hand, the Change could be requested by the purchasing department.

Supervision is always carried out by the quality control department, which usually sets up a local and/or global Change Control Committee, to which the most significant and relevant Change Controls are periodically presented, evaluated and discussed with the various impacted departments and where final authorisation is given.

 

Documentation

The Change Control system requires a written procedure (change control program) to resolve the following points.

  • Which types of change the Change Control system should take into account. To which sections these operating instructions apply.

  • Who can suggest/initiate the Change.

  • How a change can be requested (form, digital system or other communication methods).

  • How changes are classified. Who is responsible for the evaluation.

  • How the measures necessary for implementing the change are determined and who compiles the required information.

  • Who is responsible for carrying out and monitoring all necessary measures.

  • How the Change Control Committee is assembled and which tasks it has.

  • How the change will be documented (format, content, memory).

  • Who is responsible for authorising the changes.

  • What are the special rules for urgent changes.

The challenges of Change Control

The Change Control system is complex and therefore presents many challenges and difficulties. In particular:

  • Communication. Poor communication between departments, lack of follow up or escalation of change requests, delayed or inappropriate notification by suppliers, etc.
  • Processing time. Many companies manually manage change requests and documentation. This causes a lot of effort, more management time and a higher risk of errors, backlog and loss of data and documents. Digitisation does not replace approvals and tasks, but simplifies compilation, information sharing and alerts on upcoming deadlines, thus increasing control of the process.
  • Ineffective documentation. A manual system makes it more difficult to update the documentation, including the revision history, and to recover the data necessary to support the change. For example, a test might be duplicated because the documentation was not updated for the previously performed test.
  • Training: Adequate staff training is a prerequisite for both FDA and ISO. When training management is not linked to the rest of the quality control processes, especially in manual management, keeping training up to date with changes in procedures becomes complex. Procedures are usually impacted by Change and having control over the training to be given to staff greatly reduces the management time.

Change Control Management with a digital system

Change Request documentation can be managed in printed or electronic form.

Change management using a digital workflow management system not only enables documentation to be protected, organised and available, but also allows actions to be assigned to those involved, the process to be monitored and notifications to be sent ahead of deadlines, while also keeping backlogs and other critical KPIs under control.

In addition, Change Requests can connect to other processes such as CAPA.

With a digital system, the management of both processes is interdependent, so there is no risk of premature closure of one process over another.

 

PRAGMA4U is a modular and scalable Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.

It enables companies to: have documentation that is protected, always up-to-date, organised and linked to the source processes; assign and implement workactivities directly on the platform; easily share information between departments; keep processes under control using KPIs; and compile reports and dossiers that will be useful for inspections.

The platform can contain multiple processes, creating a true digital map of the company. It also integrates with other systems, such as ERP, simplifying the compilation and updating of data.

CSV & DATA INTEGRITY CONSULTING
MORE INFO

Discovering CAPA. Tools and techniques for optimising the process

Complaints as an opportunity for continuous improvement for Life Science companies

Subscribe to our newsletter

Increase your knowledge, join a community of professionals and stay up to date each week on the latest industry news.

SHARE ON SOCIAL MEDIA
excel - spreadsheets

When Excel is not the best choice

10/04/2021 |
BLOG

When Excel is not the best choice

When Excel is not the best choice

Microsoft Excelis without a doubt the most famous software in the world for managing spreadsheets. With Excel we can process data at a full 360°: organise in tables, display in graphs, calculate with matrix formulas, 3D formulas, nested formulas and much, much more.

In short, to paraphrase a well-known commercial, we could easily say “where would the world be without Excel!”.

So, what’s the problem?

Well, there are cases where using Excel isn’t exactly the most functional, simply because it was designed for different purposes! Would you ever try to unscrew a screw using a knife? Of course, maybe after a few attempts and a little effort you might succeed. But why not just use a screwdriver?

Using a less suitable tool risks worse performancewhich will inevitably spill over into our work.

Here are three situations in which the use of spreadsheets may not be an advisable choice.

1.Excel is not a Database

The usability, security and retention of data in the  Digital Transformation  are crucial.  Recording,  archiving,  analysing  and modifying data daily and easily therefore becomes a priority for the company.

It is possible to carry out all of these tasks in Excel by managing spreadsheets as databases.

However, the program has some limitations:

  • it takes a long time to compile, manage and backup data;
  • it is complex to create and maintain relationships between a lot of data in different spreadsheets;
  • as the data increases, the performance of the program decreases;
  • shared management and modification may be difficult;
  • it is subject to human errors.

2. Excel is not an Editor

Filling Excel cells with long and detailed text can be very frustrating for those who have to read the file.

Excel does allow you to choose font, size, colour, spell-check, insert images and links, but it is not a text editor and cannot be used as such. A text editor allows you toorganise content hierarchically (Title, subtitle, paragraph) and with Excel this is not possible. Quotations, indexes and footers cannot be inserted. Moreover, Printing an Excel spreadsheet is a real nightmare.

3. Excel is not designed for collaborative work

In company contexts it is common to share work in Excel files. For example, different departments may record data and activities that will later be useful to other departments and to which the latter will add their own data.

Multiple people working on the same file poses significant risks: loss of data; confusion over different file versions; rescue difficulties; not being able to edit the file at the same time; just to name a few. With the online version, some limitations have been eliminated, although not all companies can use it due to policy.

Conclusions

Excel is a powerful program that performs best when analysing data, carrying out calculations and functions, and creating tables and charts. Using it for purposes that go beyond its “mission” may run the risk of reducing the efficiency and performance of the intended activity.

As mentioned, each activity has its own support tool. Using a workflow tool that has been developed specifically for managing workflows between departments, with selective archiving of data and information, with traceability for total security, with the option of synthesising information in intuitive reports and much more is undoubtedly the best choice, and especially because it easilyintegrates with other programs, such as Excel, creating a true digital map of the company.

FOR MORE INFORMATION:

10 things you should never do in Excel

Can I use excel as a database on my website?

Top 10 Disadvantages of Spreadsheets

PRAGMA4U

It enables companies to: have documentation that is protected, always up-to-date, organised and linked to the source processes; assign and implement workactivities directly on the platform; easily share information between departments; keep processes under control using KPIs; and compile reports  and dossiers  that will be useful for inspections.

The platform can accommodate several processes (e.g. Audit, Change Control, Complaints, CAPA, etc.), creating a true digital map of the company. It also integrates with other systems, such as ERP, simplifying the compilation and updating of data.

PRAGMA4U is the result of S4BT’s many years of experience in the pharmaceutical world. For this reason, the system is fully CFR 21 – part 11 compliant and was created with the specific intention of complying with
to the high quality standards of the legislation and standards that also greatly concern data integrity.

PRAGMA4U
MORE INFO

The challenges of Change Control: sharing, documentation, training and digitisation

Digital Transformation in Life Science companies: impacts and opportunities

Subscribe to our newsletter

Increase your knowledge, join a community of professionals and stay up to date each week on the latest industry news.

SHARE ON SOCIAL MEDIA
CAPA

Discovering CAPA. Tools and techniques for optimising the process

10/04/2021 |
BLOG

Discovering CAPA. Tools and techniques for optimising the process

Discovering CAPA. Tools and techniques for optimising the process

Corrective and Preventive Actions (CAPA) are currently one of the major points of observation by the FDA.

The management of CAPAs is complex and difficulties do not always depend on staff shortages, but very often they are attributable to a problem in the structure and flow of the process. How often is it the case that not all actions are tracked, not all steps are documented or even data is lost in a cluttered system with excessively long implementation timeframes.

Furthermore, corrective action should be minimised as much as possible, as a consequence of deviations, non-conformities, etc., in favour of proactive approaches such as greater use of Quality Risk Management.

Being Proactive and Preventing is less expensive than being Reactive and Correcting!

In the following paragraphs, we will reference the regulations, explore tools and techniques to improve the approach to preventive and corrective actions, answer the most frequently asked questions about CAPAs and, finally, use an infographic to demonstrate how to simplify a CAPA process using a digital system.

Tools and Techniques to improve the approach to preventive and corrective actions

There are several techniques and tools that can be used to improve the approach to corrective and preventive actions.

The RCA uses different models and tools such as:

  • Failure Mode and Effect Analysis (FMEA) is a methodology used to analyse the failure or defect modes of a process, product or system, assess the causes and evaluate the effects on the entire system/plant. Generally (but not necessarily) the analysis is carried out beforehand and is therefore based on theoretical and not experimental considerations. It allows organisations to anticipate possible defects and errors in process design during the design phase.
  • The 5 Why method consists of asking the question “why” repeatedly until you understand all the symptoms of a problem and get to the root. The method is usually used during problem-solving activities or in conjunction with other tools, such as the cause and effect diagram.
  • Ishikawa or fishbone diagram, so-called because it resembles a fishbone with a rectangle at the end containing the effect or problem. In manufacturing, the causes or factors influencing a production process are often organised into four macro-groups, which are: labour, machines (including the energy used and working and measuring instruments), materials (raw and auxiliary materials), and methods (operating procedures or practices). The Ishikawa diagram can be used as a support in brainstorming sessions with the team.
 

Despite strong regulatory pressures, not all deviations, complaints, audit results or supplier defects should trigger a CAPA. Trend analysis and risk management can help avoid the “everything is a CAPA” syndrome.

Trend Analysis: Paying attention to trends helps us understand whether a non-compliance is an anomaly or not and whether it therefore needs a CAPA process or simply corrective action following a deviation, etc. Trends can also identify minor issues before they become more risky, perform preventive actions and help to better prioritise non-compliances for further investigation.

Quality Risk Management (QRM). Quality Risk Management is a process to mitigate or eliminate risk. It starts with an initial assessment phase, up to a final periodic review. QRM is an increasingly popular process in the upstream inspection phase of any process and helps to reduce the number of open CAPAs.

The most frequently asked questions about CAPAs

What are CAPAs?

CAPAs (Corrective Actions, Preventive Actions) are a system of quality control measures designed to eliminate the causes of a deviation, non-compliance, defect or other undesirable situation in order to prevent its recurrence.

  • Corrective action acts on existing non-compliances, deviations or defects.
  • Preventive action is taken to eliminate the causes of a potential deviation, non-compliance or defect in order to prevent it from occurring.

Through a CAPA process, a company not only develops an Action Plan, but also determines, implements and monitors the effectiveness of an identified solution. Basically, through this process, the company Quality Control system is able to “self-correct” and improve itself.

Why open a CAPA?

The purpose of corrective and preventive actions is to acquire information, analyse it and identifyand investigate problems with quality in the product so ast totake appropriate and effective actions to correct the problem and prevent its recurrence.

Key to this process will be the testing and validation of corrective and preventive actions, the communication of activities to be carried out to the responsible parties, the documentation of activities and the collection and sharing of relevant information for management review.

When to open a CAPA?

CAPAs are opened following and in the presence of certain inputs. Including:

  1. Deviations
  2. Non-compliance
  3. Change Control
  4. Internal/External Audits
  5. Complaints
  6. Rejection of products
  7. Management Review
  8. Regulatory inspections
  9. Trends in process performance and product quality monitoring

Who opens the CAPA?

Usually the CAPA is linked to other “parent” processes such as Deviations, Complaints, etc., so the people who open CAPAs are those who have previously instigated another process. However, there are often committees within companies, which discuss the process and jointly decide who should be in charge of it. Quality Assurance is generally represented in the committees.

What are the reference regulations and guidelines for corrective and preventive actions (CAPA)?

The reference regulations for the management of CAPAs are:

Although CAPAs are not specifically indicated in the cGMPs for pharmaceuticals (21 CFR 210 and 211), there are requirements that are parallel to the CAPA concept. It is clear that CAPA expectations have become a current GMP for pharmaceuticals.

21 CFR 211 (e.g. 21 CFR 211.160 and 211.192) contain requirements parallel to the CAPA requirements listed in the Medical Device Regulations (21 CFR 820) (1-2).

How do you manage a CAPA using a digital system?

PRAGMA4U is a modular and scalable Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.

It enables companies to: have documentation that is protected, always up-to-date, organised and linked to the source processes; assign and implement workactivities directly on the platform; easily share information between departments; keep processes under control using KPIs; and compile reports and dossiers that will be useful for inspections.

The platform can contain multiple processes, creating a true digital map of the company. It also integrates with other systems, such as ERP, simplifying the compilation and updating of data.

PRAGMA4U
MORE INFO

Reducing the impact of Deviations and simplifying their management using digital technology

The challenges of Change Control: sharing, documentation, training and digitisation

Subscribe to our newsletter

Increase your knowledge, join a community of professionals and stay up to date each week on the latest industry news.

SHARE ON SOCIAL MEDIA
|  
electronic dossier

Handling inspections (well) through an electronic dossier

10/04/2021 |
BLOG

Handling inspections (well) through an electronic dossier

Handling inspections (well) through an electronic dossier

Life Science companies are subject to frequent inspections by partners, agencies and authorities. For example, you may receive an inspection when you introduce new lines, produce for new markets or simply have routine and/or follow-up inspections to check that the company is in line with regulations and guidelines.

A crucial stage during an inspection is the examination and review of documentation by the auditors, both in the preparation phase and during and after the inspection.

The documentation needed can be of any kind:

  • Personnel qualifications and training
  • Standard Operating Procedures (SOPs)
  • Qualification reports
  • Validation reports
  • Complaints
  • Change Control
  • Deviations
  • Etc.

Documentation Review – Remote Audits and Inspections

Documentation review has become an even more important activity for remote Audits, which, due to safety and travel constraints, have been replacing in-person audits over the last year, thanks to the great technological flexibility we have.

In remote Audits, the company being inspected (auditee) sends the required documentation to the inspectors (auditors) via a shared and previously agreed platform.

Now, imagine this documentation stage using paper systems, from the initial search for the document, to scanning it, saving the file in the folder and then sending. Quite a cumbersome process, if we consider, too, that it must be repeated for many documents.

Having those documents in digital form, on spreadsheets or in text files and saved in network folders, would certainly reduce the time involved. We also know that even in the most precise organisation, paper files in folders are prone to errors, losses and deterioration. 

 

Electronic dossier

Digitalising  work processes on a software platform that complies with regulatory standards and offers the ability to manage assets, digital signatures, attachments and documents is crucial during an inspection. 

Here is a practical example. An inspector wants to see documentation on deviations and related CAPAs for a particular batch. For paper documentation, as mentioned above, we would need to search in the archive folders, then scan them and share on the platform. For network files and folders, if we are organised, then we can “manage” with searching for all batch-related files and sharing them.

With a digital platform, by entering the batch number and using a simple search, we can trace one or more of the deviations the batch has encountered, the documents signed electronically, the tasks performed and also the relevant CAPAs. Once we have entered the single deviations process, we can extract a dossier, i.e. a protected pdf document summarising all information on the deviation and related processes and tasks, updated in real time and including attachments. 

The dossier can be opened, viewed, saved and printed, if necessary. During an inspection, especially remotely, it is extremely easy to go back to the documentation and share the dossier as a generated pdf file.

Customised Electronic Dossiers

The Standard Electronic Dossiers contain all the information on the process (tasks, owners, attachments and documents, etc.). 

However, not all companies can, or will, share such information with third parties, if not necessarily required to do so.

With PRAGMA4U , companies can create customised dossiers, entering the relevant process information that they want to pass on to the other party. This makes it possible to use the document for sending information to third parties, such as inspectors, but also, for example, as documentation for a customer in the event of a complaint.

PRAGMA4U

PRAGMA4U is a modular and scalable Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.

It enables companies to: have documentation that is protected, always up-to-date, organised and linked to the source processes; assign and implement workactivities directly on the platform; easily share information between departments; keep processes under control using KPIs; and compile reports  and dossiers  that will be useful for inspections.

The platform can contain multiple processes, creating a true digital map of the company. It also integrates with other systems, such as ERP, simplifying the compilation and updating of data.

PRAGMA4U
MORE INFO

Discovering CAPA. Tools and techniques for optimising the process

The challenges of Change Control: sharing, documentation, training and digitisation

Subscribe to our newsletter

Increase your knowledge, join a community of professionals and stay up to date each week on the latest industry news.

SHARE ON SOCIAL MEDIA
digital transformation

Digital Transformation in Life Science companies: impacts and opportunities

10/04/2021 |
BLOG

Digital Transformation in Life Science companies: impacts and opportunities

Digital Transformation in Life Science companies: impacts and opportunities

Digital Transformation: we have all heard these words at least once. Especially in recent months, in the light of the pandemic. Many companies are dealing with remote contacts, overproduction and the adoption of digital tools in order to continue their business.

Digital Transformation,  however, goes beyond the introduction of new technologies, leading rather to a total rethinking of the organisation and posing more cultural than technological challenges.

In the following paragraphs, we will analyse the meaning and impact of digital transformation and what scenarios and challenges lie ahead for the Life Science businesses.

Digital Transformation

Digital Transformation has been talked about since the late 1990s, as an approach that involves the whole company and introduces changes in the business at a technological, cultural, organisational, social, creative and managerial level.

Digital Transformation encourages participants to share, be transparent and inclusive in the process and places the recipient of the final service at the centre of the development, if not actually participating in it.

Digital Transformation is a ‘gateway’ to the future and to maintaining competitiveness in the marketplace. Companies that have already implemented projects related to the use of new technologies achieve “a profitability that is 26% higher than other companies and a market value increase in the region of 12%”.

According to a SAP report, most companies understand the importance of digital change, but only 3% have implemented digital transformation projects within the company.

Companies that are considered leaders in Digital Transformation have the following characteristics:

  • they consider Digital Transformation to be at the very core of their business (96%) and technology as highly important for achieving a competitive advantage (93%). With this in mind, leaders are also rethinking their business models;
  • they prioritise customer contact activities. The 92% of leaders in Digital Transformation have already set up strategies and processes for improving customer experience. Generally speaking, they consider the latter to be the gateway to successful digital transformation;
  • they invest heavily in digital research and training of employees, so as to be ready for change. The 71% of leaders also state that investing in digital transformation makes it easier to attract and retain talent;
  • they are built on a bimodal structure. This is an organisational model that takes into account a company’s technological tradition and brings this element together with the more typically innovation-oriented aspects. This enables the business to be run efficiently while at the same time introducing new technologies to remain competitive, especially Big Data and Analytics (94%), Machine Learning (50%) and Internet of Things (76%).

Departments that are most often digitised in the Life Sciences sector

 

For Life Science companies in particular, being part of a digital ecosystem implies easier communication and sharing of data, extending from regulating bodies right up to the patient.

 

Of great interest in this respect is a study conducted by KPGM on digitisation within the Life Science businesses of Germany, Switzerland and Austria. The research looked at 75 companies, including pharmaceutical, medtech and other Life Science companies. 

The departments with the greatest digitisation are IT and Quality Assurance. Quality Assurance is also the area where most digitisation projects are planned. The areas least affected at the time of the research were logistics and production. Although in recent months, there has been a sharp increase in interest and projects in these areas.

Just the increase in efficiency is, according to the research, one of the major benefits of deploying digital technologies, including the agile design of R&D processes (39%). Closely followed by the advantage of optimising Quality & Compliance processes (28%).

 

Efficient internal processes and an agile approach

 

Before implementing a technological solution, it is advisable to reflect on our own internal processes. How they can be simplified. Only then should we ask how a digital tool can fit in. Without this prerequisite, there is a risk that instead of increasing productivity, the technologies will lead to further wasted time for the staff using them.

Another issue to consider is transversal collaboration with internal and external stakeholders who will make use of the technology, even if not managing it directly. The advice is to involve them and create cross-functional teams within the company and the group to jointly evaluate and test the new technology, the impacts it will have and how to manage them.

The agile approach can help with tackling the uncertainty of a new technology and the change it entails, as it allows the best solution to be implemented gradually while making quick decisions.  The agile approach involves setting up working groups that are horizontal to the organisation’s hierarchy for rapid prototyping and testing of the best solutions.

Culture and digital skills

Amongst the biggest challenges for more than80% of Life Science companies (KPGM report), are the lack of digital skills and acceptance of new technologies on the part of employees.

The introduction of new technologies might in fact be  seen as replacing human activities with the consequent risk of job losses. Therefore, fear of this may lead, consciously or unconsciously, to employees’ resistance to change. If this is the case, management should intercept the fear and convey the message that Digital Transformation is an opportunity to increase one’s skills, remain competitive in the labour market and have the opportunity of changing a repetitive job for a more valuable one within the company.

Companies often employ coaches to help them establish a culture of digital change.

When it comes to lack of digital skills, many companies have undertaken to retrain their employees. Starting with an assessment, they have provided personalised routes for digital growth. Training of this kind certainly involves a significant investment. Many companies in KPMG’s research expressed considerable doubt about their ability to develop such skills.

In this respect, a critical parameter in the digital transformation process is a clear definition of the qualified employee profile that will be required in the future. The training system must therefore adapt to these requirements with specific training programmes.

PRAGMA4U
MORE INFO

Discovering CAPA. Tools and techniques for optimising the process

The challenges of Change Control: sharing, documentation, training and digitisation

Subscribe to our newsletter

Increase your knowledge, join a community of professionals and stay up to date each week on the latest industry news.

SHARE ON SOCIAL MEDIA