Corporate Quality Manual

The FDA Compliant, Corporate Quality Manual (CQM) is a lengthy fully detailed manual containing all the policies and procedures that the regulatory authorities require approved organisations, to have in place.
The CQM is the start of all FDA compliant documentation. The policies container in it, dictate what documents must be raised and details their scope. Here our CVM goes a great deal further in containing templates for all these documents.
The FDA is continually increasing the compliance pressure, with CAPA issues cited in up to 50% of 483 warning letters, no FDA-regulated company can afford to set aside their CAPA plans. Recently high profile FDA citations to pharmaceutical, biotech and medical device companies have run into hundreds of millions of dollars. This does not include class action lawsuits brought by consumers, which are becoming more commonplace in today’s litigious society. It has never been as important as it is now, to have all your procedures and policies documented, in a company approved format.
This Corporate Quality Manual contains over $3500.00 of generic interactive document templates. These quality templates are in world wide use.

The FDA has raised the bar. The rationale for change, the approach it has taken and the progress achieved are not as good as some think. In September 2003, The Wall Street Journal published an article informing all that pharmaceutical “manufacturing techniques lag behind those of potato-chip and laundry-soap makers.” The same article correlated the rise in recalls with quality problems and noted that despite fines in excess of US$500 million for manufacturing failures, acceptable levels of quality were not being achieved.
Since then, the FDA, and the industry have been actively, working together to shape the new quality requirements and standards. Compliance now requires a quality systems approach starting with “quality by design” in development and ending with scientific process control in manufacturing. So today, products are more complex; cash is scarcer; and quality requirements require more fundamental understanding. Pharmaceutical companies need to take action on each of these issues in a comprehensive manner.

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