Regulatory compliance

Compliance is far from the only potential benefit of a dedicated document collaboration solution. The right solutions can offer our Q-Pulse customers a solid foundation for success and scalability.

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PleaseReview gives you a perfect audit trail. I have made its acquisition a requirement at every organization for which I’ve led medical writing.

Kim Norris, Director of Medical Writing, uniQure

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CFR 21 part 11

The FDA requires organisations to use a document collaboration solution that fully complies with CFR 21 part 11. The criterion under these regulations requires electronic records, electronic signatures, and hand-written signatures executed on electronic records to be trustworthy, reliable and equivalent to what would be executed on paper.

Compliance is far from the only potential benefit of a dedicated document collaboration solution. The right solution can offer a solid foundation for success and scalability. By fully understanding the business benefits of the right system and the key features to look for, you can implement a solution which scales with your organization's needs.

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Equivalent to paper records and hand-written signatures executed on paper.
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Reliable
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Trustworthy

Moving from CSV to CSA

The speed and efficiency of computer software validation (CSV) has emerged as a key focus over recent years, with the FDA set to release their new approach: Computer Software Assurance (CSA).

One of the key findings of a 2011 review of data quality was that Computer Software Validation (CSV) had become a burden for life science companies. CSV seemed to have shifted the industry's focus to passing audits with extensive documentation requirements. They also found that less time and effort was spent concentrating on quality.

Discover the pain points of CSV and how you can get ahead of the game and prepare to align your organisation to the FDA’s new CSA approach.

Prepare to align your organisation to the FDA’s new CSA approach

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Auditability and reporting

Simply monitoring documents as they are being produced is not enough. As documents are created, reviewed, edited, and finalised, you need a way of seeing who did and said what and when. Establishing a controlled environment that is only accessible to those granted permission and with the secure link can ensure complete safety of data and intellectual property.

Auditing and reporting can be made easy when collaborating on documents in a single environment where an automatic trail of activity is recorded every step of the way. The automatic reconciliation report in PleaseReview captures all the activity undertaken on the document review, including time stamp data, all comments, edits, and suggested changes; everything an auditor needs to see.

The risk of non-compliance

Life science companies have an obligation to protect the sensitive data and information they have and produce. 

Using a secure, effective document collaboration solution that meets FDA compliance requirements enables you to decrease the amount of time it takes to collate, consolidate, and inspect documents. A single environment which enables you to collaborate efficiently, automatically audit and pull detailed reconciliation reports prepares you for a surprise inspection, encourages an ethical mindset throughout and establishes you as a trustworthy company; all of which helps to mitigate legal consequences.

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Discover how PleaseReview can meet your regulatory needs

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Additional Resources

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