Well-written documentation and a comprehensive and well-designed Pharmaceutical Quality System (PQS) can be a manager’s best friend. Pharmaceutical Quality System (PQS) documents: provide guidance and instructions for employees to complete the day-to-day activities are the ‘go-to’ during an audit or inspection are the first reference point when inducting new employees. But designing a good PQS…
What is the Medical Device Single Audit Program (MDSAP)? The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 as a pilot program, satisfying the requirements of the pilot program in December 2016. MDSAP allows a MDSAP recognized third party Auditing Organisation (AO) to conduct a…
Quality Management System software providers have matured in recent years, with an increasing number entering the Pharmaceutical and Medical Device industries and marketing themselves as 21 CFR Part 11 and ISO 9001 compliant. The fact is that QMS software providers have all gone to the cloud with many offering a purely web-based service. Only a…
Since 2006, PharmOut has been a leading provider of highly regarded and coveted Quality Management Systems (QMS) template packs. Purchasing is simple and facilitated through our online shop – a simple click here, pay there, and you will be able to download a “zip file” of the QMS template of your choice, be they for…
What you need to know about PIC/S GMP Documentation Tips The TGA’s announcement of its intention to adopt PIC/S GMP PE 009-13 as of 31 December 2017 means Australian GMP manufacturers need to review their current document retention schedules and practices to maintain compliance. PharmOut’s leading PIC/S GMP consultants have studied the new guidance and…
Please complete the form on the contact us page. We will get back to you within one business day.
Phone: +61 3 9887 6412
Email: info@pharmout.net
