Importance of Data Integrity and Document Management
In recent years there has been increased emphasis on data integrity, as this is a critical factor for the manufacturer in measuring the quality of their product and their credibility.
What is Data integrity?
Every organisation knows the saying, ‘If it isn’t written down, it didn’t happen’, this is fundamental in a manufacturing environment. Data is essential in the manufacturing process, without data how can the integrity of the product or processes be proven, without data it is harder to identify risks and opportunities for improvement.
The FDA identify data integrity as ‘the completeness, consistency and accuracy of data. Complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original and accurate (ALCOA)’.
Why is data integrity a challenge?
A loss of data integrity can lead to severe consequences in terms of patient safety and can affect the reputation of the organisation. Small inconsistencies or inaccuracies in data can cause significant problems these are all too common in the manufacturing environment i.e. product recall or loss of sales.
There is a greater risk of data integrity issues with paper QMS, whereas an electronic QMS automatically tracks changes by creating an audit trail of changes applied. The audit trail captures the ‘who, what, when and why’ of a record.
There are small controls a company can put in place, from each employee having a unique login to a machine or software which processes information generated during the manufacturing process. Maintaining an audit trail, data back-up /disaster recovery and most importantly, the protection of records.
How to implement data integrity into your process?
- Good documentation practices
- Create unique logins for users
- Only allow access to trained individuals to the appropriate software
- Implementation of a second check or check authorisation at critical process steps during the product lifecycle
- Equipment qualification
- Software validation
- Maintain confidentiality of data
- Data back up
- Ensure there are cybersecurity controls in place
Why implement effective data integrity processes?
Patient safety is integral to medical device manufacturers, this however begins with the manufacturing processes. Maintaining good data integrity processes throughout the product lifecycle, is the basis to ensure the final product’s identity, strength, purity and safety. KD&A can help your organisation creating and implementing a QMS, as well as, assisting your organisation with all related medical device requirements.
June 27, 2019