Convenient QA Aps
Decentralized Clinical Trials
QA Consultant
QUALITY IS WORTH IT
General Principles
Quality is Control
A quality management system is about you taking control of your business. Any systematic method for control is a quality system.
Capture Learning
Inventing new methods and creating novel skills is expensive and time consuming. Re-inventing the same again and again is bad business. Quality is about using what has been lerned.
Manage Risk
Ignoring risks to your business does not make the risks go away. Managing risk feels like opening Pandoras Box, only the curses has already been released. With Risk Management, you can do something about it.
Create Confidence
Dealing with customers and regulators is all about creating confidence that you are in control of your business and the quality of your product. The Quality Management System justifies their confidence.
Create Benefits
Any Quality Management System must be a benefit and a help to anyone working with or under it. If not, it must be updated until it is a benefit, otherwise it will not be used and all the benefits will be lost.
Understand your business
Feeling that you understand your business and makes it succesfull is vastly different than putting it to words and writing it down. The act of formulating it will reveal new knowledge, or identify areas for investigation.
WE CAN DO IT
Services
Decentralized Clinical Trials
New methods and techniques are emerging from Decentralized Cinical Trials. Many require new procedures and regulatory acceptance in order to be used. Understanding the “why” of current clinical trial practices are essential to incorporate the new parts even if most of the trial use traditional methods.
Building, using and maintaining a GCP compliant quality management system is an absolute need and requirement. Using a system that furthers execution instead hindering it is good business.
Vendor Auditing
Understanding your vendoes and knowing what they can and can’t do for your business is vital. Some vendors are unable to perform as expected. Some pose unwanted risks to supply or compliance. Some are outright dangerous to your company.
The first step is to make sure you know that you want them to do for you. The second step is to determine what kind of risks they pose to your company. The final step is to make sure they fit your needs and your risk appetite. Anything from searching their website to a multi day onsite audit may be needed.
Data Protection Officer
GDPR are the rules for how to handle data privacy and data protection. For any organization interested in protecting personal privacy, compliance is easy, but there are a number of activities that must be performed anyway from an overview of data processing in the company to vendor management, including vendor audits.
Often a Data Protection Officer is not needed, but data privacy management and guidance is still an issue that must be taken care of.
Data privacy connects many areas including the quality system, risk management andIT security. An understanding of all areas makes for a smoother integration.
Risk Management
Identifying the risks to the company, to processes, to decisions, to plans and vendors is the first step in understanding and handling the risks The true benefit from risk management comes when risk assessments are integrated in as many activities as possible. Not only do risk assessment identify risks that need to be mitigated or accepted. It can also identify non-issues otherwise thought to be important, and justify not wasting resources on it.
If risk assessment is not easy to perform, then it will not happen, and important risks will remain unknown and unmitigated.
Other services
Pharmacovigilance
Collecting, assessing and reporting adverse events and adverse reactions is an absolute legal requirement. These activities must be incorporated into all other activities.
IT Security
Basic IT security and security policies have become a basic requirement from authorities and customers.
Customer Audits
Being successfully audited by authorities and customers is not simple, but there are techniques available to help demonstrate compliance.
Deviations & Incidents
Recording, assessing and implementing learnings from incidents and deviations demonstrates a learning organization. Doing it in a timely manner requires attention and assigned responsibilities.
Validated Software Development
Validation of software is a requirement everywhere, but even if it wasn’t, who would dare use software without being sufficiently sure it works.
Internal Audit
Internal audits of departments and functions ensures that learning and improvement is a management focus area, building confidence with authorities and customers.