MS tools: Life line for cGMP audits

S Aparna, Director, Nichelon Infotech Services

An industry like Pharmaceuticals is naturally subject to stringent governmental regulations.
Inadequate knowledge about the jobs handled, or the latest techniques (cGMP: current Good
Manufacturing Practices), and other technical aspects of the trade, will lead to deteriorated
performance and risk exposure. Competency management thus is not just desirable but is also a
mandatory requirement under GMP.
Team competency
Entire teams in the pharma industry need to remain up to date in technology and standard
operating procedures. This is possible only with meticulously planned and scrupulously
executed training programmes, backed up with frequent and periodical refresher courses. Only a
team of individuals with proven and certified competence can deliver the expected performance.
Team competency management is as important as mitigation of risk due to regulatory non-
compliance.
Competency management and business results
The world today is knowledge driven as never before. The Competency Management in an
organisation is a measure of its business maturity and a key contributor for its success. Only a
systematic and holistic approach towards competency management with reliable and
dependable tools would result in high standards of safety that meet stringent regulations, and
also would yield enhanced business results. It is an organisation that seriously conducts
competency studies and undertakes Competency Management Programs that becomes a Star
Performer!
IT enabled Competency Management
In even a moderately sized organisation, it may be an onerous task to track manually, the
current levels of technical knowledge and related skills of individual employees and to design
and schedule appropriate and effective training programmes for the targeted individuals to
educate them intensively or to update them periodically. It is even more difficult to
convincingly demonstrate this to the governmental and other autonomous authorities that
impose, inspect and enforce stringent regulations. You therefore need to automate the whole
process by using the tools of Information Technology. A good CMS will make a significant
difference to your team skills and competence.
Six questions a good CMS must answer
A good Competency Management System (CMS) must answer all the six important questions
related to Training Management:
Who - the Individuals or Groups or Teams to be Trained
What - the Subjects of Training must be
How - the method or mode of Training, and Evaluation
When - the schedules of Training Programmes
Where - the Venues are to be
Whether - the Training is complete and appropriately Documented
A good CMS must also be much more than just a faithful keeper of Training Programme
records.
Future ready versatility
You will naturally not want a quick fix solution for a CMS but a thoughtfully developed tool. A
good CMS must have both versatility and foresight. It must provide for built-in document
repositories for version controlled SOPs, preparation of Question Banks, random Question
Papers, Batching, Attendance marking, On-line /
Off-line Training, Objective Evaluation, Certification, Tracking, Maintaining Training History,
and Costing, and also provide Reports and Analytics.
The CMS must have innovative methods of mapping groups / sub groups with the
corresponding training needs in the required subjects and the methods of training, to address the
needs of training right from shop floor team member to the senior management level. It should
be able to provide for Classroom, External, Content delivery, Review methods of Training,
Trainer / Trainee feedback for training effectiveness, On-line / paper based examination /
testing, Trainer Qualification and re-qualification, and Generation of GMP Training
Certificates. It must also address the re-training needs.
Training assessment and compliance
Training assessment is the most important part of the training in order to know the effectiveness
of the training. The CMS must facilitate a 360 degree assessment possibility. Some of the very
important assessments made through the CMS are: Immediate trainee assessment, long-term
assessment, Shop Floor Assessment, Trainer Feedback, assessment through testing and grading.
As already mentioned, the competence must be demonstrably assessed. It must therefore
maintain all the required records and Audit Trails to assure full compliance to the regulations.
How well equipped are you now
To have a winning edge in a regulated industry, you need to conduct a review on your current
practices of managing the Training Needs in your organisation. You need to ask yourself: Is our
training documentation current? Do we train our employees, and document their training for the
changes in SOP? What system do we have to ensure that all copies of authentic training
documentation are current and contain identical information, regardless of where it is kept?
How effective and fast is our information retrieval process? Should a Regulatory Authority like
an FDA inspector demand for it as part of a routine GMP inspection, can we access it fast
enough and convince the authority demonstrably enough?
How to achieve worry-free improvements
All that you need to make remarkable improvements over the present practices is to get yourself
an efficient CMS, which will answer all your questions and concerns about competency
management. One such is Nichelon5 CMS. It is painstakingly and thoughtfully developed, after
considerable research, by Nichelon Infotech Services., based at Hyderabad, the Pharma and
Technology Capital of Andhra Pradesh. It is a Competency Management tool that is specially
developed for managing the needs of Training and Competency of the Teams. It ensures
conducting of planned training with assured compliance to stringent regulations. Its systematic
and planned approach is focused on helping organisational leaders solve critical talent
management challenges from succession planning to performance improvement to aligning
workforces with organisational goals. Some well known pharma companies have been using
Nichelon5 CMS and are extremely happy with the planning and execution of training and the
help it renders during regulatory audits.
A feature-rich CMS
Nichelon5 CMS is built on cutting edge technology to cover the five activities regulating the
training operations in an organisation - Identifying, Planning, Executing, Evaluating and
Tracking. It has all the features that a good and versatile CMS must have. It thus helps you
manage the complete training lifecycle of the work force as per the GMP requirements.
Comprehensive functionality, easy to manage workflows and high level of configurability are
some of its key features. With this kind of a CMS you can ensure and track the training of any
type and enforce FDA training requirements.
Life line for cGMP audits
Regulatory auditors are keen to know how well each team member is equipped to handle his/her
specific role in GMP environment. A quick report is worth more than a hundred explanations
and Nichelon5 CMS provides comprehensive Reports and Analytics. It also maintains all the
required records and Audit Trails to assure and demonstrate full compliance to FDA's 21 CFR
Part 11 regulations on Electronic Records and Electronic Signatures.
Technology
Nichelon5 CMS is built on robust Web Technology Enterprise grade application architecture. It
has a scalable architecture, and hence is capable of easily meeting the training needs whether
the enterprise is large or small. Since it is built on Web-Technology, it is just installed on the
server and operated through a browser.
This is a huge benefit and saving as validation is done only for the server, sparing area all the
trouble of validating each computer that is being used for training. Due to the n-tier architecture
that it follows, it is easy to implement and maintain for many years after implementation.
Administration
Nichelon5 CMS is administered with role-based security, with configurable and separate
security profiles for electronic signature and application authentication. It is designed to work in
a regulatory regime, with its high compliance to stringent regulations on electronic documents
and electronic signatures. Complete audit trails will be maintained for masters and training
programs registration and approval. Nichelon5 CMS readily presents all the essential
information for the Training Program Implementer or the other top brass, to view at a glance in
the form of configurable Dashboards on the user's Home Screen.
Low cost of ownership
Since Nichelon5 CMS is designed in 100% Web Technology, it ensures a low cost of
ownership, and easy maintainability. It is the most affordable competency management tool that
ensures Training to your Staff and assures Compliance to Regulations.
S. Aparna is the Director, Nichelon Infotech Services , Hyderabad, A.P. (www.nichelon.com)