Lachman Consultants offer the highest quality produce and excellent regulatory compliance for their customers. Industry leaders in compliance and regulatory affairs in the pharmaceuticals and technical services industry they have clients all around the world. They only employ the highest calibre of staff and the salaries that are paid are set accordingly
What then are the best ways to stay compliant in an industry that is overloaded with regulation, compliance standards and documentation? One of the simplest ways to deal with this is to piece together a list of the rules and regulations that will apply specifically to your company. This is because compliance is best achieved when you have simple and clear sets of rules to follow. This does not mean that the legislation is superfluous and unnecessary, just that it has developed and changed over time so that there are rules then further rules all relating to similar areas.
The rules in writing compliance and legislative documents to ensure ease are to keep it clear, do not make it complex when this is unnecessary. This will reduce errors. If you try to cover too much in one section of the compliance manual it will inevitably become more complicated and thus less likely to be followed. When creating your risk based model do not aim to cover every scenario in one go. High and frequent risks would be covered but lower ones could be left and discussed in other documents. When you are creating your suite of compliance documents ensure that your different types of document covers guidance or clear instructions on the process that must be followed.
A frequent mistake that is made in compliance documents is that as well as stating the regulatory guidance it will go onto describe the steps of doing a certain job or task. This should be avoided. If required separate instructions should be created to as instructions on how to do a certain job or task.
You should ensure that all your documents in your suite are held in an orderly filing system. A really good index for the system is an essential requirement.
You must be aware that training will need to be given on these documents to all employees including any new ones. Lachman consultants of Westbury New York have a rigorous and extensive training program. You will need to ensure that the documents may need to be changed or amended as new legislation is introduced. The pharmaceutical industry is ever changing and you will need to update your document quickly and concisely. The management team will need to decide whether the changes will require further intensive training for the team or whether they can be loaded on a quick email and a quick chat with the team. Again this will defend upon the severity of the change and its importance.
If you have different branches of your company you will have to decide whether you do central compliance or let your various branches and departments deal with it all independently.
Once you have created your documents. Considering the major purpose and requirements of them, then when you have delivered your training, kept it up to date, revisit the documents when required; you will be up to the Lachman standard.