President's Message

At the start of each year, many people make resolutions aimed at improving something about themselves. Pharmaceutical companies should follow a similar approach to ensure that they minimize potential risks of non-compliance. An annual assessment of your quality system is an excellent way to avoid non-compliance surprises.

Drumbeat Dimensions, Inc. can help you conduct a compliance assessment and reduce your risk of unexpected compliance issues. We can assess the health of your quality system by performing the following services in an efficient and effective manner:

• Analysis of your Standard Operating Procedures (SOPs) to ensure that you have addressed the applicable regulatory requirements
• Analysis of SOP quality of key SOPs to ensure that they adequately address critical aspects of the GMPs
• Audit operations to ensure that SOPs are being followed
• Assess validation efforts to determine if processes and systems are properly validated and that validation is properly documented
• Assess CAPA process to verify that corrective and preventative actions are being identified and addressed
• Assess your change control process to verify that changes are being reviewed and addressed in an effective and efficient manner

Contact me for more information on how Drumbeat Dimensions, Inc. can help achieve and maintain a healthy compliance outlook.

Tim Fields
President, Drumbeat Dimensions, Inc.