If there were not already enough tasks to complete and IT tickets to resolve, no one wants to carve away an entire day (or even take away a personal weekend) to shut all systems down - and ‘test’ the Disaster Recovery (DR) Process. The Disaster Recovery SOP serves to...
At ADAMAS, we’re passionate about helping the businesses we serve with computer systems compliance (CSC). But just what does that mean, and how has it changed over the years? I had an interesting conversation recently with a QA colleague, reminiscing about the origins...
Some time ago I was lucky enough to be invited to tour the Mercedes AMG Petronas Formula One (F1) team headquarters in Brackley, Northamptonshire, UK – just a stone’s throw from the legendary Silverstone motor racing circuit – and to watch the Monaco Grand Prix from...
Is your organisation in the dark when it comes to the quality and compliance status of your computer systems and computer system vendors? At ADAMAS, we’re in the privileged position of working alongside a wide range of sponsor organisations, CROs and computer system...
There is no doubt you are aware of the UK’s intention to leave the EU on Friday 29th March 2019, and that following the planned departure, EU law – including those on medicinal products – shall cease to apply in the UK. Nevertheless, there are still ongoing...
Ministry of Health & Family Welfare, Government of India, has released the Pharmacovigilance (PV) Guidance for Marketing Authorization Holders (MAHs) and it will be effective from Jan-18. The guidance document intends to enable the MAHs to set up a PV system at...
As informed earlier in our blog, the Ministry of Health and Family Welfare, India, has mandated the accreditation of Ethics Committees (ECs), involved in supervision of clinical trials, with effect from 01-Jan-18. The accreditation will be conducted by National...
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published their latest Good Pharmacovigilance Practice (GVP) Inspection metrics covering the period April 2015 – March 2016. Within this period a total of 35 inspections had been carried out,...
The ICH E6 (R2) has been formally adopted by the ICH assembly held in Osaka, Japan on 5-10 November 2016. All changes proposed in ICH E6 (R2) Step 2 have been accepted in principle, within the ICH E6 (R2) guideline during Step 4 adoption by the ICH Assembly. A...
According to the Office Order dated 03-Jul-14 issued by the CDSCO, a Principal Investigator could not conduct more than three (03) clinical trials at any given period of time, irrespective of whether those clinical trials were actively recruiting or were in long term...
Come and meet ADAMAS Consulting at the RQA European QA Conference, Belfast
Computer Software Assurance (CSA): Why the Change and What Does it Mean?
Annex 1 Revisions: What are the Changes and Whom will they Affect?
Why Is Data Integrity Important When Transferring Data in a Clinical Trial?
ADAMAS and Ergomed combine to expand global capabilities