-
29/May/2019
4 BENEFITS A KNOWLEDGE BASE CAN BRING TO YOUR ORGANISATION
The value of a knowledge base should not be underestimated, but what are the actual benefits? Read on to discover more.
-
25/Jan/2019
HOW TO IMPLEMENT A SUFFICIENT DATA GOVERNANCE POLICY TO ENSURE COMPLIANCE WITH DATA INTEGRITY REGULATIONS IN THE LIFE SCIENCES SECTOR.
Data Integrity Regulations have beocme vital to organisations, here is how to Implement a Sufficient Data Governance Policy in the Life Sciences Sector.
-
07/Nov/2018
AUDIT TRAIL REVIEW FOR DATA INTEGRITY: CRITICAL QUESTIONS YOU MUST ASK TO ENSURE YOUR COMPANYS SYSTEMS STACK UP TO FDA GUIDELINES
Audit trail is a record of the “who, what, when, and why” of a record. Data integrity arrangements must ensure that the accuracy, completeness, content and meaning of data is retained throughout the data lifecycle. How does your Company’s systems stack up to this FDA Guideline?
-
22/Aug/2017
THE FUNDAMENTALS OF DATA INTEGRITY : ALCOA +
In this post we explain the fundamentals of Data Integrity via the acronym ALCOA+ that defines the framework required to achieve and maintain Data Integrity.
-
12/Aug/2015
PERFORMING A DRY RUN OF TEST SCRIPTS IN THE VALIDATION PROCESS: A WASTE OF TIME OR A COST SAVER?
Dry Runs are often misunderstood. While they can be of huge benefit to a project, time and again they do not get factored into the testing schedule, and so, they can become a ‘nice to have’ rather than a mandatory part of the testing cycle.
-
01/Aug/2015
GAMP 5: ARE YOU UP TO DATE WITH THE LATEST VALIDATION BEST PRACTICES?
GAMP – Good Automated Manufacturing Practices was founded in 1991 and is a trademark of the International Society for Pharmaceutical Engineering (ISPE). GAMP-5 was launched in 2008 and includes a set of procedures that help to ensure automation equipment/software meets required quality standards.
- Back to Blogs
Dataworks Blog