Data integrity is the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle, it includes the actions and measures implemented to maintain the security, reliability, consistency and quality of data, regardless the format or medium chosen to create, register, process, archive and use them.
Qualipharma has the knowledge and experience required to support companies with different business lines, with facilities placed in different locations and with different processes performances; we can guide your company through the homogenization and standardization of the data integrity implementation in order to reach a global and unique approach of its units and guarantee the existing regulations accomplishment.
At the present, the Data Integrity is one of the most important aspect considered by the regulatory authorities while undertaking inspections, especially by the FDA; Recently this aspect has risen steeply due to several deficiencies found in many pharmaceutical companies. Even though, the requirements to ensure the data integrity are still the same for no matter the format or medium chosen (paper, electronic), an increasing number of companies choose to develop its processes and operations through computerized systems. As result, many aspects must be taking into consideration, such as:
- Computerized system interchange electronic data with other systems so it becomes highly important to include proper verifications which guarantee the right data entry and the correct and safety processing of data.
- Controls to restrict the access to the computerized systems to people authorized must be incorporated (keys, personal cards, passwords, etc.).
- The Data Archiving should only be possible when the documents validity, accessibility, readability and integrity is checked and proved. Any time important changes on the systems are made, it is a must to guarantee and prove the ability to quickly retrieve the data.
- The way to demonstrate a system data integrity is through the system validation.
It is important to identify the risks inherent to the Data Integrity since they can vary depending on the data grade configuration and therefore if the data manipulation could potentially exist or not. The Data Integrity incorporation must be considered as an integral element in the global management system of the company and not as separate part. Qualipharma provides the support needed to guarantee the data quality and integrity on every phase of your company systems and technologies:
- Support on systems development.
- Identification of the relevant and critical records.
- Data and Metadata identification.
- Risk Assessment. Standardization, definition of the company criteria.
- Identification of areas and data flow.
- Systems validation.
- Development of politics and procedures for the maintenance of the data integrity
- Extensive experience team, with reference position in this sector due to the high amount of successful cases
- Deep knowledge on data integrity and new technologies
- Work Integration
- Experts on developing solutions for the data integrity implementation adapted to your company process, methodology and policy