The FDA will release a draft guidance this month on how it will interpret International Organization for Standardization (ISO) audit reports when determining its inspection priorities for device makers, an agency director says. Under the FDA Amendments Act, which reauthorised the Medical Device User...

Hi Martin Thank you for your reply I am thinking of this from Two directions 1 - Staff members need to have records of their accidents in and around the lab i.e. needle stick injuries, cuts, trips breaks. also we need to log accidents that are major as IR1s as well - we do this as CA/PAs at the moment...

Real name: Mohammed Arfan (but known as Arfan) City/Country you live: Oldham, Greater Manchester, England Job Title: Quality Assurance Co-ordinator Company: Oldham Council I am currently working within the Adult & Community Services and we are using Q-Pulse primarily to record and monitor Complaints...

One of our customers in the aviation sector is producing some nice results with the Audit module beyond the traditional JAR-OPS, Part 145 etc. compliance areas where they are now using it for Operations Standards Audits and IOSA. Do you have any similar experiences?

Hi, Yes, Q-Pulse can be used to fully develop a robust Business Continuity system. We are in the final stages of development, and have been able to use the Customer, Suppliers, Documents, Training, and Audit modules to develop a structure that works for us - essentially placing our entire plan throughout...

Hi David, I was looking more for a standard checklist, that lists internal audit questions to the CPA standard. Thanks Gregor

Do you want something in QPulse audit checklist format (e.g. exported as .pdf) or an attached (Word, Excel) format Gregor? I can let you have some wonderfully old fashioned vertical audit checklists in Word format and some horizontal CPA audit checklists in Word & Excel. More recently, I composed...

Today, we announced the release of the latest version of our compliance management software. Q-Pulse is an integrated compliance management solution that helps Life Sciences organisations to proactively manage regulatory activities such as Auditing, Document Control and CA/PA in compliance environments...

Diseases such as heart disease, infectious diseases and cancer threaten the lives of billions worldwide, and every year millions more are exposed to life-threatening diseases for which there is no effective treatment. Maintaining and improving quality is vital in designing and developing effective vaccines...