Quality Management Systems (QMS) for Wholesalers can be built by a consultant alone, but the best QMS is one which has input from the Company, the staff who carry out the activities and the managers who are responsible for the business and specific processes within the scope of the licence.

One the QMS has been, reviewed, signed by the Responsible Person, issued, everyone must be trained or retrained and have their competence checked. then the hard work begins. Compliance with the controlled documents, maintenance of the logs or registers controlling and recording the issue of forms is just the start of the cycle of events.

All documents and records must be kept for at least 5 years, but first they must be created following ALCOA principles. What are ALCOA principals?

“A “is for “Accurate “

“L” is for “Legible”

“C” is for “Contemporaneous”

“O” is for “Original”

“A” is for” Attributable”

The records should be readily available for future reference, by internal or external auditors and in case of recall.

Records must be filed correctly and in line with the SOP. Back-ups of electronic data must be tested and a report created to accurately define the findings.

The QMS must be led from the top, and all staff members should be involved, everyone should have an opportunity to request a change and to help improve the QMS. A new QMS can take up to three years to bed in.