More and more pharma companies along with companies in the healthcare and life sciences sector are turning to replace wet ink signatures in documents with computer-generated documents to speed up work and lower cost. While the use of computers and computer systems for operations is unrestricted for industries, for the previously mentioned regulated industries things are slightly different. For using computers in the regulated sectors as part of the manufacturing, quality control, and other operations, it is necessary to use software approved by FDA. Salesforce software is ideal because it comes as validation ready software and its features meet the requirements stipulated in 21 CFR Part 11, considered the bible of the regulated industries.
cGMP and more
For following the best practices of the industry, pharma, healthcare and life sciences, industries have to comply with cGMP (Current Good Manufacturing Practices) in their operations. According to the experts at Flosum.com, to introduce the use of computer-generated documents for operations, it is necessary to comply with 21 CFR Part 11. The regulatory requirement is applicable for companies that want to use electronic signatures and electronic records for record keeping of their regulated information. Companies involved in the manufacture, handling, and distribution and warehousing of drugs, biologics and medical devices come under the purview of the regulation. The purpose of using computer-generated documents is to reduce paperwork, eliminate wet ink signatures, accelerate regulated product approvals and lower the costs of review and approval of regulated and critical data as well as its transmission.
Significance of Part 11 compliance
The credibility of manual documents and manual signatures are much higher than computer-generated documents that people can fake at will. Manual documents have more authenticity and easy to attribute it to the creator as compared to the electronic documents. Complying with Part 11 ensures that the authenticity of electronic documents and electronic record keeping matches with that of manual documents. Organizations regulated by the FDA intending to use electronic documents for their operations have to use Salesforce software after due validation for compliance with Part 11.
Compliance means assurance
Companies that meet the requirements of Part 11 are declaring the following.
- The information contained in the system is reproducible and valid.
- The stakeholder of the documents has certified the completeness of the record.
- Signatures are irrefutable and represent the person’s affirmation of their signature legally binding on them, and there is no possibility of altering dates.
Salesforce has features that enable companies to achieve compliance with Part 11 and maintain it in their applications.
The meaning of validation
Once you validate the Salesforce software, it means that the software is capable of adhering to the FDA guidelines with respect to use of computers and capable of generating documents that are authentic and reliable. Data integrity is uniform throughout, signatures and dates appearing on the documents are sacrosanct, and you can never change it.
Salesforce software gives the confidence to users that they are following the best practices in the industry.